Psychological interventions for needle-related procedural pain and distress in children and adolescents

  • Conclusions changed
  • Review
  • Intervention

Authors


Abstract

Background

This review is an updated version of the original Cochrane review published in Issue 4, 2006. Needle-related procedures are a common source of pain and distress for children. Our previous review on this topic indicated that a number of psychological interventions were efficacious in managing pediatric needle pain, including distraction, hypnosis, and combined cognitive behavioural interventions. Considerable additional research in the area has been published since that time.

Objectives

To provide an update to our 2006 review assessing the efficacy of psychological interventions for needle-related procedural pain and distress in children and adolescents.

Search methods

Searches of the following databases were conducted for relevant randomized controlled trials (RCTs): Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; PsycINFO; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); and Web of Science. Requests for relevant studies were also posted on various electronic list servers. We ran an updated search in March 2012, and again in March 2013.

Selection criteria

Participants included children and adolescents aged two to 19 years undergoing needle-related procedures. Only RCTs with at least five participants in each study arm comparing a psychological intervention group with a control or comparison group were eligible for inclusion.

Data collection and analysis

Two review authors extracted data and assessed trial quality and a third author helped with data extraction and coding for one non-English study. Included studies were coded for quality using the Cochrane Risk of bias tool. Standardized mean differences with 95% confidence intervals were computed for all analyses using Review Manager 5.2 software.

Main results

Thirty-nine trials with 3394 participants were included. The most commonly studied needle procedures were venipuncture, intravenous (IV) line insertion, and immunization. Studies included children aged two to 19 years, with the most evidence available for children under 12 years of age. Consistent with the original review, the most commonly studied psychological interventions for needle procedures were distraction, hypnosis, and cognitive behavioural therapy (CBT). The majority of included studies (19 of 39) examined distraction only. The additional studies from this review update continued to provide strong evidence for the efficacy of distraction and hypnosis. No evidence was available to support the efficacy of preparation and information, combined CBT (at least two or more cognitive or behavioural strategies combined), parent coaching plus distraction, suggestion, or virtual reality for reducing children's pain and distress. No conclusions could be drawn about interventions of memory alteration, parent positioning plus distraction, blowing out air, or distraction plus suggestion, as evidence was available from single studies only. In addition, the Risk of bias scores indicated several domains with high or unclear bias scores (for example, selection, detection, and performance bias) suggesting that the methodological rigour and reporting of RCTs of psychological interventions continue to have considerable room for improvement.

Authors' conclusions

Overall, there is strong evidence supporting the efficacy of distraction and hypnosis for needle-related pain and distress in children and adolescents, with no evidence currently available for preparation and information or both, combined CBT, parent coaching plus distraction, suggestion, or virtual reality. Additional research is needed to further assess interventions that have only been investigated in one RCT to date (that is, memory alteration, parent positioning plus distraction, blowing out air, and distraction plus suggestion). There are continuing issues with the quality of trials examining psychological interventions for needle-related pain and distress.

Résumé scientifique

Interventions psychologiques contre la douleur et la détresse de procédures impliquant des aiguilles chez les enfants et les adolescents

Contexte

Cette revue est une version mise à jour de la revue originale Cochrane publiée dans le numéro 4, 2006. Les procédures impliquant des aiguilles sont souvent source de douleur et de détresse pour les enfants. Notre revue précédente sur ce sujet a indiqué qu'un certain nombre d'interventions psychologiques étaient efficaces dans la prise en charge pédiatrique contre la douleur impliquant une aiguille, y compris la distraction, l'hypnose et les interventions cognitives et comportementales combinées. Un nombre considérable de recherches supplémentaires dans ce domaine a depuis été publié.

Objectifs

Pour mettre à jour notre revue de 2006, évaluant l'efficacité des interventions psychologiques contre la douleur et la détresse de procédures impliquant des aiguilles chez les enfants et les adolescents.

Stratégie de recherche documentaire

Des recherches sur les bases de données suivantes ont été réalisées pour trouver des essais contrôlés randomisés (ECR) : Le registre Cochrane des essais contrôlés (CENTRAL) ; MEDLINE ; EMBASE ; PsycINFO, le Cumulative Index to Nursing and Allied Health Literature (CINAHL) ; et Web of Science. Des demandes d’études pertinentes ont également été envoyées sur divers serveurs de listes électroniques. Nous avons effectué une recherche mise à jour en mars 2012 et en mars 2013.

Critères de sélection

Les participants étaient des enfants et des adolescents âgés de 2 à 19 ans se soumettant à des procédures impliquant des aiguilles. Seuls les ECR avec au moins cinq participants dans chaque groupe d'étude, comparant un groupe d'intervention psychologique et un groupe témoin ou de comparaison, étaient susceptibles d'être inclus dans la revue.

Recueil et analyse des données

Deux auteurs de la revue ont extrait les données et évalué la qualité des essais et un troisième auteur a contribué à l'extraction des données et de codage pour une étude non anglaise. La qualité des études incluses a été codée en utilisant la méthode d'évaluation Cochrane sur le risque de biais. Les différences moyennes standardisées avec des intervalles de confiance à 95% ont été calculées pour toutes les analyses à l'aide du logiciel Review Manager 5.2.

Résultats principaux

Trente-neuf essais totalisant 3 394 participants ont été inclus. Les procédures d'insertion d'aiguilles les plus couramment étudiées étaient les ponctions veineuses, les insertions de tubes intraveineux (IV) et les vaccinations. Les études incluaient des enfants âgés de 2 à 19 ans, avec la plupart des preuves disponibles chez les enfants de moins de 12 ans. En accord avec la revue originale, les interventions psychologiques les plus couramment étudiées pour les procédures d'insertion d'aiguilles étaient la distraction, l'hypnose, et la thérapie comportementale cognitive (TCC). La majorité des études incluses (19 sur 39) ont uniquement examiné la distraction. Les études supplémentaires issues de cette revue mise à jour ont continué de fournir des preuves solides de l'efficacité de la distraction et de l'hypnose. Aucune preuve n’était disponible pour soutenir l'efficacité de la préparation et de l’information, la TCC combiné (au moins deux ou plusieurs stratégies comportementales cognitives ou combinées), les conseils parentaux plus la distraction, les suggestions ou la réalité virtuelle pour réduire la douleur et la détresse. Aucune conclusion n'a pu être apportée concernant les interventions d’altération de la mémoire, le positionnement des parents plus la distraction, l’inspiration et l’expiration ou la distraction plus la suggestion, étant donné que les preuves disponibles étaient uniquement issues d'études uniques. De plus, les scores de risques de biais indiquaient plusieurs domaines avec des risques de biais élevés ou incertains (par exemple, la sélection, la détection et les biais de performance), suggérant qu’une amélioration à la rigueur méthodologique et à la notification des ECR sur les interventions psychologiques doit être effectuée.

Conclusions des auteurs

Dans l’ensemble, il existe des preuves solides étayant l'efficacité de la distraction et de l'hypnose contre la douleur et la détresse de procédures impliquant des aiguilles chez les enfants et les adolescents, avec aucune preuve actuellement disponible pour la préparation et l'information ou des deux, la TCC combinée, le conseil parental plus la distraction, la suggestion, ou la réalité virtuelle. Des recherches supplémentaires sont nécessaires afin d'évaluer les interventions qui, jusqu’à ce jour, ont été étudiées dans seulement un ECR (qui est l’altération de la mémoire, le positionnement des parents plus la distraction, l’inspiration / expiration et la distraction plus la suggestion). Il existe des problèmes permanents sur la qualité des essais examinant des interventions psychologiques contre la douleur et la détresse de procédures impliquant des aiguilles.

Resumo

Intervenções psicológicas para dor e desconforto de procedimentos relacionados com agulha em crianças e adolescentes

Introdução

Esta avaliação é uma versão atualizada da revisão Cochrane original publicada na Edição 4 de 2006. Procedimentos relacionados com agulha são uma fonte comum de dor e desconforto para crianças. Nossa revisão anterior sobre este tema indicou que uma série de intervenções psicológicas foram eficazes no controle da dor nos procedimentos pediátricos com agulha, incluindo distração, hipnose e intervenções cognitivo-comportamentais combinadas. Pesquisas adicionais consideráveis na área têm sido publicadas desde aquela época.

Objetivos

Fornecer uma atualização para nossa revisão de 2006, avaliando a eficácia de intervenções psicológicas para a dor e desconforto em procedimentos relacionados com a agulha em crianças e adolescentes.

Métodos de busca

Foram conduzidas buscas nas seguintes bases de dados, para ensaios clínicos controlados randomizados relevantes (ECCRs): Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL) e Web of Science. Pedidos de estudos relevantes também foram postados em vários servidores de listas eletrônicas. Fizemos uma busca atualizada em Março de 2012 e, novamente, em Março de 2013.

Critério de seleção

Os participantes incluem crianças e adolescentes com idades entre dois e 19 anos, submetidos a procedimentos relacionados com agulha. Somente ECCRs com, pelo menos, cinco participantes em cada braços do estudo, comparando um grupo de intervenção psicológica com um grupo controle ou de comparação, foram elegíveis para inclusão.

Coleta dos dados e análises

Dois revisores extraíram os dados e avaliaram a qualidade dos ensaios clínicos e um terceiro autor ajudou com a extração de dados e codificação de um estudo não-inglês. Os estudos incluídos foram codificados para a qualidade usando a ferramenta de viés 'Cochrane Risk'. As diferenças de médias padronizadas, com intervalos de confiança de 95%, foram calculados para todas as análises usando o software Review Manager 5.2.

Principais resultados

Foram incluídos 39 ensaios clínicos, com um total de 3394 participantes. Os procedimentos com agulha mais comumente estudados foram punção venosa, uso de medicação intravenosa e imunização. Os estudos incluíram crianças com idades entre dois e 19 anos, com maior evidência para crianças abaixo de 12 anos. Consistente com a revisão original, as intervenções psicológicas mais comumente estudadas para os procedimentos com agulhas eram distração, hipnose e terapia cognitivo-comportamental (CBT). A maioria dos estudos incluídos (19 de 39) examinaram somente a distração. Os estudos adicionais nesta revisão atualizada continuaram a fornecer fortes evidências para a eficácia da distração e da hipnose. Nenhuma evidência estava disponível para apoiar a eficácia da preparação e informação, combinadas com TCC (pelo menos duas ou mais estratégias cognitivas ou comportamentais combinadas), instrução aos pais mais distração, sugestão ou realidade virtual para reduzir dor ou desconforto infantil. Nenhuma conclusão pode ser tirada sobre as intervenções de alteração de memória, posicionamento dos pais mais distração, soprar o ar ou distração mais sugestão, pois as evidências estavam disponíveis apenas a partir de estudos individuais. Além disso, o escore de risco de viés indicou vários domínios com escores alto ou incertos (por exemplo, seleção, detecção e viés de desempenho), sugerindo que o rigor e descrição metodológicos das ECCRs para intervenções psicológicas continuam tendo considerável espaço para melhorias.

Conclusão dos autores

No geral, há uma forte evidência apoiando a eficácia de distração e hipnose para dor e desconforto relacionados com agulhas em crianças e adolescentes, sem evidência atualmente disponível para preparação e informação ou ambos, TCC combinada, instrução aos pais acrescida de distração, sugestão ou realidade virtual. Pesquisas adicionais são necessárias para avaliar ainda mais intervenções que só foram investigados em um ECCR até a data (que é, alteração de memória, posicionamento dos pais mais distração, soprar o ar e distração com sugestão). Há contínuos problemas com a qualidade dos ensaios clínicos que examinam intervenções psicológicas para dor e desconforto relacionados com agulha.

Notas de tradução

Tradução da Unidade de Medicina Baseada em Evidências da Unesp, Brazil (Esther Angélica Luiz Ferreira) Contato: portuguese.ebm.unit@gmail.com Translation notes: CD005179

Plain language summary

Psychological interventions for needle-related procedural pain and distress in children and adolescents

Psychological interventions (for example, distraction, hypnosis, coping skills training) are treatments used to reduce pain and distress (anxiety and fear, or both) that children and adolescents experience while undergoing medical procedures involving needles. There is strong evidence that distraction and hypnosis are effective in reducing the pain and distress that children and adolescents experience during needle procedures. Distraction techniques can often be quite simple, such as reading the child stories, watching television, listening to music, or talking about something other than the needle. Sometimes parents or nurses are involved in helping to distract the child, although that is not always necessary. Interventions such as hypnosis may require some teaching by a trained professional for a child to learn. Other psychological treatments, such as explaining what is going to happen before or during the procedure (labelled 'providing information or preparation or both'), using virtual reality (for example, interactive video equipment, goggles, computers showing images, games, stories), or a combination of various strategies have been tested. More research is needed to know whether they are effective for reducing children's pain and distress during needles.

Résumé simplifié

Interventions psychologiques contre la douleur et la détresse de procédures impliquant des aiguilles chez les enfants et les adolescents

Les interventions psychologiques (telles que la distraction, l'hypnose, la formation en habiletés d’adaptation) sont des traitements utilisés pour réduire la douleur et la détresse (l'anxiété et la peur, ou les deux) que les enfants et les adolescents expérimentent lors de procédures médicales impliquant des aiguilles. Des preuves solides montrent que la distraction et l'hypnose sont efficaces pour réduire la douleur et la détresse que les enfants et les adolescents ressentent pendant les procédures d'insertion d'aiguilles. Les techniques de distraction peuvent souvent être assez simple, telles que lire une histoire à l'enfant, regarder la télévision, écouter de la musique, ou discuter d’autre chose que l'aiguille. Parfois les parents ou les infirmiers sont impliqués pour aider l’enfant à se distraire, bien que cela ne soit pas toujours nécessaire. Les interventions telles que l'hypnose peuvent nécessiter un enseignement à l’enfant par un professionnel qualifié. D'autres traitements psychologiques ont été testés, tels qu’expliquer ce qui va se produire avant ou pendant la procédure (appelé « fournir des informations ou préparer ou les deux), utiliser la réalité virtuelle (par exemple, des équipements vidéo interactifs, des lunettes de protection, des ordinateurs montrant des images, des jeux, des histoires), ou une combinaison de différentes stratégies. Des recherches supplémentaires sont nécessaires pour déterminer s'ils permettent de réduire la douleur et la détresse des enfants pendant les procédures impliquant des aiguilles.

Notes de traduction

Traduit par: French Cochrane Centre 14th January, 2014
Traduction financée par: Ministère du Travail, de l'Emploi et de la Santé Français

Resumo para leigos

Intervenções psicológicas para dor e desconforto de procedimentos relacionados com agulha em crianças e adolescentes

As intervenções psicológicas (como, por exemplo, a distração, a hipnose, treinamento de habilidades) são tratamentos utilizados para reduzir dor e desconforto (ansiedade e medo, ou ambos) que crianças e adolescentes experimentam ao serem submetidos a procedimentos médicos com agulhas. Há fortes evidências de que a distração e a hipnose são eficazes na redução da dor e do desconforto que crianças e adolescentes experimentam durante procedimentos com agulhas. Técnicas de distração podem ser bastante simples, como ler histórias infantis, assistir televisão, ouvir música ou falar sobre algo diferente do que a agulha. Às vezes, pais ou enfermeiros estão envolvidos em ajudar a distrair a criança, embora nem sempre seja necessário. Intervenções, como a hipnose, podem exigir algum ensinamento de um profissional treinado para uma criança. Outros tratamentos psicológicos, como explicar o que vai acontecer antes ou durante o procedimento (chamado de "fornecer informações" ou preparação ou ambos), usar realidade virtual (como, por exemplo, equipamentos de vídeo interativo, óculos, computadores que mostram imagens, jogos, histórias) ou uma combinação de várias estratégias, têm sido testados. É necessário maiores pesquisas para saber se eles são eficazes para reduzir dor e desconforto em crianças durante as picadas.

Notas de tradução

Tradução da Unidade de Medicina Baseada em Evidências da Unesp, Brazil (Esther Angélica Luiz Ferreira) Contato: portuguese.ebm.unit@gmail.com Translation notes: CD005179

Background

This review is an update of a previously published review in the Cochrane Database of Systematic Reviews (2006, Issue 4) on 'Psychological interventions for needle-related procedural pain and distress in children and adolescents'.

Description of the condition

Medical procedures are a common source of pain and distress for children. Healthy children undergo immunizations repeatedly throughout childhood. The Advisory Committee on Immunization Practices (ACIP 2004), the American Academy of Pediatrics (AAP 2004), the American Academy of Family Physicians (AAFP 2004), and the Canadian Paediatric Society (CPS 2004) all recommend over 20 various immunizations before age 18 years. Children with chronic illnesses experience an even greater number of painful procedures, as part of the diagnosis, treatment, and monitoring of their condition. In a hospital setting, children often experience unpredictable and severe procedure-related pain (Cummings 1996) that can be associated with negative emotional and psychological implications (Kazak 2001). Despite the prevalence of pain stemming from medical procedures and the distress associated with this, research indicates that pain management continues to be suboptimal. For example, a recent investigation of the epidemiology and management of painful procedures in children in Canadian hospitals found that 78% of patients admitted to inpatient units had undergone a painful procedure; however, less than a third of the painful procedures had documented pain management interventions (Stevens 2011).

Evidence-based clinical guidelines for reducing the pain of childhood vaccinations do exist (Taddio 2010). These guidelines promote a '3-P' approach to pain management, which includes pharmacological, physical, and psychological factors. In terms of psychological approaches, the guidelines recommend various cognitive and behavioural techniques that are effective at reducing vaccination pain (for example, deep breathing) as well as various techniques that are ineffective for vaccination pain (for example telling children reassuring comments like 'it won't hurt').

Description of the intervention

Medical procedures, particularly needles, are among the most feared experiences of children (Broome 1990). It is important to note that identifying positive adaptive or negative maladaptive intervention strategies should be based on evidence. While intuitively it might appear that reassurance (for example, saying 'don't worry' or 'it’s going to be ok') would help to decrease pain and distress during needle procedures, there is a large body of evidence to indicate that it is actually distress-promoting (for example, Manimala 2000). Various mechanisms have been proposed to explain this, including reassurance indicating to the child that the parent is worried, reinforcement of child distress behaviours by attention, or permission to the child to freely express his or her distress (McMurtry 2006; McMurtry 2010).

A number of psychological interventions for managing pain and distress in children are available, of which the majority are cognitive behavioural in nature. Although non-pharmacological interventions for pain that are not cognitive behavioural exist (for example, acupuncture, heat or cold), these interventions were not included in the present review. The borderline between psychological and non-psychological interventions is difficult to define, often because some interventions could arguably fit into more than one category. For example, coughing and deep breathing could both arguably fall under the categories of psychological (for example, distraction) or physical interventions. We would argue that the classification of interventions into distinct mutually exclusive categories would misrepresent the processes involved.

Cognitive interventions include techniques that target negative or unrealistic thoughts to help replace them with more positive beliefs and attitudes (for example, saying positive self-statements such as 'I can get through this' instead of 'this is going to hurt'). Behavioural interventions include techniques that target negative or maladaptive behaviours to help replace them with more positive and adaptive behaviours (for example, watching a funny movie instead of talking about how much the needle will hurt). Cognitive behavioural therapy (CBT) uses a combination or variation of cognitive or behavioural, or both, strategies targeting both thoughts and behaviours (Barlow 1999). CBT for pain management aims to help individuals develop and use coping skills to manage their pain and distress, and can include various techniques such as distraction, relaxation training, deep breathing, hypnosis, preparing for and rehearsing the procedure in advance, using positive reinforcement for adaptive behaviours, making positive coping statements, and receiving coaching to use adaptive strategies (Chen 2000a ; Christophersen 2001 ; Keefe 1992). While it can be challenging to identify the exact processes or mechanisms that each of the interventions target, efficacy is in part a function of many dimensions such as intervention novelty, engagement, and developmental appropriateness.

As noted above, although CBT-based interventions are often described as 'psychological' in nature, this does not mean they are limited to use or direction by psychologists. On the contrary, most of these techniques are quite straightforward (for example, distraction, deep breathing), require no intensive training to use, and can be delivered by various healthcare workers (for example, nurses, child life specialists) as well as family members, such as parents. However, certain techniques do require some training and knowledge for maximum effectiveness (for example, diaphragmatic breathing is more involved than taking a few deep breaths).

Operational definitions of specific cognitive or behavioural interventions (for example, hypnosis, memory alteration, distraction) are available by request from the authors.

How the intervention might work

Cognitive interventions include techniques that target negative or unrealistic thoughts to help replace them with more positive beliefs and attitudes (for example, saying positive self-statements such as 'I can get through this' instead of 'this is going to hurt'). Behavioural interventions include techniques that target negative or maladaptive behaviours to help replace them with more positive and adaptive behaviours (for example, watching a funny movie instead of talking about how much the needle will hurt). CBT uses a combination or variation of cognitive or behavioural, or both, strategies targeting both thoughts and behaviours (Barlow 1999). For the purpose of this review, all of the cognitive, behavioural, and cognitive behavioural strategies described above fall under the overarching category of ‘psychological’ interventions. As a whole, psychological interventions for pain management aim to help individuals develop and use coping skills to manage their pain and distress, and can include various techniques such as distraction, relaxation training, deep breathing, hypnosis, preparing for and rehearsing the procedure in advance, using positive reinforcement for adaptive behaviours, making positive coping statements, and receiving coaching to use adaptive strategies (Chen 2000a; Christophersen 2001; Keefe 1992).

Why it is important to do this review

Several narrative, non-systematic reviews and book chapters on psychological interventions for the management of procedural pain and distress in children are available (for example, Alvarez 1997; Blount 2003; Chen 2000a; Christophersen 2001; Devine 2004; Kazak 2001; Powers 1999; Young 2005). These reviews have typically concluded that psychological interventions are beneficial; however, the lack of a systematic and pooled approach to integrating the literature is problematic and can mean that only limited conclusions regarding the efficacy of these interventions are made. Although there have been a few examples of more systematic approaches to integrating this literature (for example, Broome 1989; Kleiber 1999; Luebbert 2001; Saile 1988), these reviews have tended to adopt a more limited focus (for example, examining the effects of only one type of intervention such as distraction) and many are out of date given the rapid growth of research in this area in recent years.

We conducted and published our original Cochrane Review (Uman 2006; Uman 2008) to provide a comprehensive, systematic review of the efficacy of different psychological interventions for managing procedure-related pain and distress in children. Based on that original review, we established the efficacy of several interventions (namely distraction, hypnosis, and CBT) and made several clinical and research recommendations, including identifying interventions requiring further research. We also made recommendations for improving the quality of trials in the area, which were explored in more depth and outlined in a subsequent paper (Uman 2010). At the time of our initial review only 28 RCTs met our inclusion criteria and provided the necessary data for inclusion in our meta-analysis. Since the publication of our initial review, considerable additional research in the area has been published. Therefore, this updated review was meant to expand upon our original review by identifying and including the more recent RCTs and synthesizing the results of these more contemporary studies with our prior work to make stronger conclusions about the efficacy of these interventions. We also used a risk of bias measure in this update to evaluate the risk of bias for all of the included studies. The current updated review combines findings across a larger sample, which strengthens and expands our conclusions regarding the efficacy of psychological interventions for needle-related procedural pain and distress in children and adolescents.

Although we wished to conduct sensitivity analyses to examine more specific age ranges or developmental periods, the broadness and variability in the study sample age ranges limited these analyses. In addition, the majority of RCTs in this area assessed single event needle procedures rather than repeated or multiple needle procedures, thereby precluding the ability to assess this area further. As such, we did not include these analyses in this updated review but acknowledge the importance of these areas of inquiry for future research.

Objectives

To provide an update to our 2006 review assessing the efficacy of psychological interventions for needle-related procedural pain and distress in children and adolescents.

Methods

Criteria for considering studies for this review

Types of studies

Only randomized controlled trials (RCTs) with at least five participants in each study arm were included. In contrast to our original review in which we included quasi-randomized trials (for example, alternative assignment) in a sensitivity analysis, for this updated review we included only true RCT designs and excluded all quasi-randomized trials. A study was deemed to be a true RCT if the authors explicitly stated that participants were randomly assigned to groups (for example, assignment was determined using a table of random numbers) and did not indicate using quasi-randomization methods (for example, alternating assignment) at any point in the paper. For example, some authors may describe the study as an RCT in the title or abstract but later report quasi-randomization techniques in the methods sections. A true RCT is one that is described as such throughout the entire paper. While we were more lenient in the original review and included a few studies reporting quasi-randomization procedures, these studies were excluded from the present review in order to be more consistent and stringent in our approach. In addition, unlike in our original review, we included only published trials and therefore excluded any non-published trials (for example, dissertations). No language restrictions were used during the search and translations were obtained when necessary.

Types of participants

Studies involving children and adolescents aged two to 19 years undergoing needle-related medical procedures were included. For the purposes of this review, a needle-related medical procedure was defined as any procedure performed as part of a medical diagnosis, prevention, or treatment. This included dental procedures (excluding dental surgery) but did not include procedures such as body piercings or tattoos, which involve needles but are not performed for medical purposes. The search was limited to needle-related pain, which is among the most commonly occurring and feared procedures for both healthy and chronically-ill children (Broome 1990). Our justification for not including children less than two years of age is that the majority of psychological interventions examined in this review are either not appropriate for use with infants or are qualitatively different when applied to infants. The efficacy of psychological interventions for procedural pain and distress in infants has been addressed in another review (Pillai-Riddell 2011a; Pillai-Riddell 2011b). For both the original review and this review update, we included studies with participants ranging from two to 19 years of age. A maximum age of 19 years was chosen to ensure that our search was limited to children and adolescents only, and is also consistent with the World Health Organization (WHO) definition of adolescence, which defines it as ranging from 10 to 19 years (http://www.searo.who.int/en/Section13/Section1245_4980.htm). The age range was kept broad so as to not exclude any relevant studies; however, studies that included any participants falling outside of this age range were excluded unless authors were able to provide data for only the age range specified for this review while also continuing to meet the minimum criterion of five participants per group.

We included studies examining medical procedures from the same list of procedures identified in our prior review (please see Table 1 for the list of medical procedures and their definitions). Definitions were derived from online medical dictionaries (for example, MedlinePlus Medical Encyclopedia, MedLine 2004; On-Line Medical Dictionary, OLMD 2004) and by consulting with medical professionals in the area of pediatric pain. Participants included healthy children and children with chronic or transitory illnesses from both inpatient and outpatient settings. Studies including patients with known needle phobias (that is, diagnosed by a qualified professional such as a psychologist) were excluded. While we acknowledge that needle fears are quite prevalent and some youth included in the reviewed studies may have had undiagnosed phobias, this criterion was established in an attempt to distinguish between typical needle fears or ones that are extreme enough to have warranted assessment and diagnosis prior to the study. Furthermore, children undergoing surgery were excluded because numerous factors specific to surgery or being in intensive care units can complicate and interfere with the accuracy of self-reported accounts of pain and distress. These factors may include sedation, inability to verbalize because of intubation, more intensive pharmacological interventions, long-term hospital stays, inability or difficulty attributing pain or distress to one specific medical procedure, and difficulty distinguishing between the pain and distress caused by the procedure versus the medical condition requiring the surgery (Puntillo 2004). The exception to this was for studies that assessed the efficacy of a psychological intervention for a pre-surgical needle procedure such as an intravenous (IV) insertion. The outcome measures of interest had to be completed prior to surgery or sedation in order for the study to be included in this review.

Table 1. Definitions of medical procedures
ProcedureDefinition
Immunization (also known as immunisation)Protection against a particular disease or treatment of an organism by protecting against certain pathogen attacks; the introduction of microorganisms that have previously been treated to make them harmless.
Venepuncture (also known as venipuncture)The surgical puncture of a vein typically for withdrawing blood or administering intravenous medication.
Finger prick/pinObtaining blood by puncturing the tip of the finger.
InjectionThe act of forcing a liquid into tissue, the vascular tree, or an organ.
Subcutaneous injectionInjection administered under the skin.
Intramuscular injectionInjection administered by entering a muscle.
Lumbar punctures (LP) (also known as spinal tap)The withdrawal of cerebrospinal fluid or the injection of anesthesia by puncturing the subarachnoid space located in the lumbar region of the spinal cord.
Bone marrow aspiration (BMA)The bone marrow is the tissue that manufactures the blood cells and is in the hollow part of most bones. This test is done by suctioning some of the bone marrow for examination.
Bone marrow biopsy (BMB)The removal and examination of tissue, cells, or fluids from the bone marrow of a living body; usually performed at the same time as a BMA.
IV/catheter insertionA narrow short, flexible, synthetic (usually plastic) tube known as a catheter, that is inserted approximately one inch into a vein to provide temporary intravenous access for the administration of fluid, medication, or nutrients.
Central line (also known as central venous catheter)Insertion of a catheter into the large vein above the heart, usually the subclavian vein, through which access to the blood stream can be made. This allows drugs and blood products to be given and blood samples withdrawn.
Suture (also known as laceration repair)A stitch made with a strand or fiber used to sew parts of the living body.
Accessing a portacath (also known as a port)Insertion of a needle into an implanted access device (portacath) which facilitates the drawing of blood and intravenous (or intra-arterial) injections by not having to locate and insert a cannula into a new vessel. Some ports are connected for intrathecal, intraperitoneal or intracavitary injections.
Arterial punctureA hole, wound, or perforation of an artery made by puncturing.
Arterial blood gas (ABG)A test which analyses arterial blood for oxygen, carbon dioxide and bicarbonate content in addition to blood pH. Used to test the effectiveness of respiration.
Arterial line (also known as intra-arterial catheter)Insertion of a catheter into an artery.
Thoracocentesis (also called thoracentesis)Aspiration of fluid from the chest.
ParacentesisA surgical puncture of a bodily cavity (e.g. abdomen) with a trocar, aspirator, or other instrument usually to draw off an abnormal effusion for diagnostic or therapeutic purposes.

Types of interventions

Studies were included if at least one trial arm consisted of a psychological intervention, and there was a comparator control arm, other active treatment, treatment as usual, or waiting list control. We excluded studies in which the psychological intervention(s) was combined with a non-psychological intervention (for example, pharmacological intervention) when the unique effects of the psychological intervention could not be evaluated.

Types of outcome measures

The two measured outcomes of interest were pain and distress, assessed using scales or measures with established reliability and validity (that is, as evidenced in at least one prior study published in a peer-reviewed journal). For this review, pain was operationalized using the definition proposed by the International Association for the Study of Pain (IASP), describing pain as: “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage” (IASP 2004). In addition, distress was broadly defined as any type of negative affect associated with the procedure (for example, anxiety, stress, fear). Because the main focus of this review was the data pooling component (that is, the meta-analysis), as with the original review, RCTs were excluded if the data necessary for data pooling (for example, means, SDs, cell sizes) were not available in the published study, could not be identified through contact with the study authors, or could not be calculated based on other data provided (for example, confidence intervals).

Primary outcomes
1) Self-report

Measures of pain and distress may include various versions of the following (Champion 1998):

• Visual Analogue Scales (VAS);

• Numerical Rating Scales (NRS);

• Verbal Rating Scales (VRS);

• faces Scales designed to assess level of pain or distress (for example, anxiety or fear, or both).

2) Observer Global Reports

Observer versions of the self-report measures for pain and distress listed above (completed by parents, caregivers, nurses, doctors, or other hospital staff present) were also included. It is important to note that there are various factors affecting the degree to which observer reports are positively correlated with self-reports of pain and distress, such as the person completing the report (that is, mother, nurse, or doctor) and the age of the child (Champion 1998). Despite these caveats, observer reports of pain and distress can provide valuable information, particularly for younger children.

3) Behavioural Measures

These include behavioural observation measures, typically completed by trained researchers or medical staff. They may include but are not limited to the following commonly used scales (McGrath 1998).

Pain Scales

• The Children’s Hospital of Eastern Ontario Pain Scales (CHEOPS) (McGrath 1985)

• The Faces Legs Activity Cry Consolability Scale (FLACC) (Merkel 1997)

Distress Scales

• The Observational Scale of Behavioral Distress (OSBD) (Jay 1983)

• The Child-Adult Medical Procedure Interaction Scale (CAMPIS) (Blount 1989), the CAMPIS-revised (Blount 1990; Blount 1997), and the CAMPIS-short form (Blount 2001)

While developmental and age factors are important considerations when selecting appropriate outcome measures, there is still considerable variability in selecting outcome measures and many are used for a broad range of ages. However, systematic reviews of self-report of pain intensity in youth aged zero to 18 years note that no scale is uniformly appropriate across development and there continues to be debate about the choice of scale to use (Stinson 2006; Tomlinson 2010). The more recent Tomlinson 2010 review suggests that faces scales are frequently used; the most widely used with the best validity are currently the Faces Pain Scale-Revised (FPS-R) (Hicks 2001), the Oucher pain scale (Beyer 1992), and the Wong-Baker Faces Pain Rating Scale (WBFPRS) (Wong 1988). However, it is important to note that several studies have found that faces scales starting with smiling no-pain anchors, such as the WBFPRS, tend to result in greater pain ratings compared to scales starting with neutral non-smiling pain anchors because they may confound affective states with pain ratings (for example, Chambers 1998). In addition, although many faces scales are validated and used with younger children (three to five years), it has been found that children this young often demonstrate response biases, such as choosing only the lowest or highest anchors (for example, von Baeyer 2009). Thus, self-reports of pain from preschoolers should be interpreted with caution and complementary observational assessments (for example, by parents) are also recommended. However, there are systematic discounting biases in some studies of parental and staff proxy ratings whereby more weight is given to certain scales or raters (for example, giving more weight to parent reports and less weight to child reports). For these reasons, it can be helpful for studies to incorporate various measures of pain and distress by different raters (for example, child, parent, staff) and this is the reason we chose to evaluate these outcomes separately in this review.

However, is it worth noting that there is also variability among observational assessments of pain and distress. In another systematic review of observational (behavioural) measures of pain for youth three to 18 years old, it was noted that pain intensity measures are not generally age-normed and there are often no separated versions of observational scales for different ages. Rather, although most observational scales were originally developed for specific ages ranges, they have been applied or expanded to a broader age range. However, despite this important issue, which warrants further research, the results of the systematic review did recommend using certain observational scales (that is, FLACC and CHEOPS) based on their sound psychometric properties for youth in this age range undergoing painful medical procedures (von Baeyer 2007).

Secondary outcomes
4) Physiological Measures

Measures of pain and distress that are practical to quantify in clinical setting may include (Sweet 1998):

• heart rate (generally increases with pain);

• respiratory rate (may increase or decrease with pain and distress or both);

• blood pressure (generally increases with pain and distress or both);

• oxygen saturation (generally decreases with pain and distress or both);

• cortisol levels (generally increase with pain and distress or both);

• transcutaneous oxygen tension (tcPO2) (generally decreases with pain and distress or both);

• transcutaneous carbon dioxide tension (tcPCO2) (may increase or decrease with pain and distress or both).

Despite concerns regarding the tendency of physiological measures to habituate in response to pain and distress, as well as a lack of data supporting the specificity of these measures to pain (McGrath 1998 ; Sweet 1998), physiological measures have frequently been assessed as outcomes in pain studies, and were therefore included as outcomes in this review. However, it is important to note that all self- and observer-rated measures of pain and distress are subjective, given that pain is a subjective experience based on a variety of factors (for example, pain threshold, previous experiences with pain, etc).

Search methods for identification of studies

Published studies were identified by conducting electronic searches and by contacting researchers using various electronic mailing lists and list servers.

Electronic searches

Through consultation with a reference librarian and with assistance from the Cochrane Pain, Palliative and Supportive Care (PaPaS) Group, detailed search strategies were developed to search the following six electronic databases for relevant trials:

  • Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 2);

  • MEDLINE (1966 to March 2013) ;

  • EMBASE (1989 to March 2013);

  • PsycINFO (March 2013);

  • Cumulative Index to Nursing and Allied Health Literature (CINAHL) (March 2013);

  • Web of Science (IBI Web of Knowledge) (March 2013).

For this updated review, the same database search terms were used as in the original review; however, we extended the search date to cover the period from when the last update ended (2005) to March 2013. Thus, altogether, the database searches covered the period from their inception to March 2013. Because we opted to include only published studies for this current review update, we excluded one additional database searched in the original review (that is, Dissertation Abstracts International). A similar search strategy was adapted for each of the databases but additional related keywords and MeSH terms were included as appropriate for each specific database. Please see the appendices for the search strategies and terms used for each of the databases: MEDLINE (Appendix 1), PsycINFO (Appendix 2), CENTRAL (Appendix 3), EMBASE (Appendix 4), IBI Web of Knowledge (Appendix 5), and CINAHL (Appendix 6).

Searching other resources

In addition to the electronic search strategy, we also put out a call for relevant studies to four e-mail list serves including: 1) Pain in Child Health (PICH), 2) Pediatric Pain, 3) the American Psychological Association’s Society of Pediatric Psychology Division 54, and 4) the American Psychological Association’s Health Psychology Division 38. Requests to these list serves were sent out for both the original review and, again, for the present review update. Any other relevant studies identified and included in the original review (for example, from reference or citation lists) were included in this update.

Data collection and analysis

1. Selection of studies

Two review authors (LU and CC) independently screened titles and abstracts of trials from literature searches for inclusion in the original review, and two additional review authors (MN and KB) independently screened titles and abstracts for the review update. For all abstracts that were relevant, potentially relevant, or where relevance to the current review was unclear, the full articles were obtained and read by one of the study authors. Using the full articles, two review authors (LU and CC for the original review, and MN and KB for the updated review) decided which studies did and did not meet the inclusion criteria. Review authors were not blind to the authors, institutions, journals, or results. A third review author (PM for the original review, and LU for the updated review) was brought in to help resolve any issues or selection discrepancies that arose.

As noted above, to increase the methodological quality of the studies included in this updated review, we imposed more stringent inclusion criteria for this review update as compared to the original review. Specifically, for this review update we omitted any non-published studies (for example, unpublished dissertations) and quasi-randomized trials (that is, anything other than reporting true random assignment, as described above). In our original review, contact with some study authors clarified that the assignment they used was indeed random assignment although it was not described as such in the paper (for example, described in the abstract as an RCT but described in the methods as using alternating assignment). Thus, to be consistent across all studies, those reporting quasi-randomized procedures in the published studies were excluded from this update even if they were included in the original review.

A total of 28 RCTs were retrieved and included in the original review, although for the current update we excluded seven of these studies because they were unpublished dissertations or reported quasi-randomized methods (that is, alternating assignment). In March 2012, our updated search strategy identified 18 additional RCTs meeting the inclusion criteria and having the necessary data to be included in this update. An additional search in March 2013 did not identify any further studies. Thus, a total of 39 RCTs (retrieved from the original and updated searches) were included in this updated review; all of these included RCTs were coded in full. The references for these studies are all provided below in the 'Description of studies' section.

2. Data extraction and management

Two review authors (LU and CC) extracted data using a data extraction form designed for the original review, and two additional review authors (MN and KB) performed data extraction for additional studies identified in the review update. In addition, another researcher who was fluent in Farsi confirmed inclusion eligibility and conducted data extraction for one non-English study identified from our updated search. Data were extracted on various details relating to study design, participant demographics, diagnosis (when applicable), needle procedure, type of intervention and control conditions, outcomes, as well as other related variables. A third review author (PM for the original review, and LU for the updated review) was available to help resolve any coding discrepancies. Data from the studies were extracted using paper data extraction sheets developed for this review and were also entered into electronic spreadsheets to differentiate between included versus excluded studies. Attempts were made to obtain missing data (for example, means, SDs, cell sizes) from the authors, whenever feasible, to include in the meta-analysis. All data for the included studies were first recorded on paper data extraction forms by review authors (LU for the original review, and MN and KB for the updated review) and reviewed for errors by a trained research assistant. All data suitable for pooling were analysed using RevMan 5.1 software (RevMan 2011).

3. Assessment of risk of bias in included studies

In the original review, each included study was scored independently for quality by two review authors using the Oxford Quality Scale created by Jadad 1996. We also completed a more extensive quality analysis of the included studies (Uman 2010) given that the Oxford Quality Rating Scale is more appropriate for double-blind studies (for example, pharmacological interventions); and psychological interventions, unlike placebo studies, typically cannot be truly double-blind. For the purpose of this updated review, we used the Cochrane 'Risk of bias' tool as a measure of trial quality. The Cochrane Handbook for Systematic Reviews of Interventions (www.cochrane-handbook.org/) distinguishes between methodological quality assessment and risk of bias, and recommends a focus on the latter (please refer to the Cochrane Handbook for a detailed account of reasons why). The Risk of bias tool is a two-part tool assessing seven areas: adequate sequence generation, allocation concealment, blinding of participants and study personnel, blinding of outcome assessment, incomplete outcome data addressed, free of selective reporting, and other biases. All included studies from the original review and those identified in this update were independently coded by two review authors (MN and KB) who then compared responses to reach consensus. This procedure was verified with, and endorsed by, the Cochrane PaPaS Review Group.

4. Measures of treatment effect

Given the nature of the outcome measures in this review, all of the outcome data for the included studies were continuous (for example, rating scales). Consistent with the analytical approach used in the original review, and as is recommended by The Cochrane Collaboration, we computed standardized mean differences (SMD) with 95% confidence intervals (CI), which allowed us to combine the results from different scales measuring the same construct (for example, pain). We proposed that when sufficient data were available from various studies using the same measurement instruments, a weighted mean difference (WMD) with 95% CI would also be conducted. However, given the wide range of different assessment measures used, this was not feasible. Thus, all mean differences presented in the tables and plots of the results section represent SMDs.

Each psychological intervention was assessed separately in a meta-analysis because the interventions were considered too different to combine. However, within each intervention we analysed each outcome measure separately. Thus, for each intervention the following seven outcomes were separately assessed.

a) Pain: self-reports.

b) Pain: observer global reports.

c) Pain: behavioural measures.

d) Distress: self-reports.

e) Distress: observer global reports.

f) Distress: behavioural measures.

g) Physiological measures: each physiological outcome (e.g. heart rate, blood pressure) was assessed separately.

5. Unit of analysis issues

In this context, unit of analysis issues refer to the level at which randomization occurs. For example, in most situations the number of observations analysed should match the number of 'units' that were randomized. In a simple, parallel two-group RCT (intervention versus control), participants would be randomized to one of the two groups and a single measurement for each outcome would be collected and analysed. For the current review, we included and analysed parallel two-group RCTs as well as cluster-randomized trials (that is, groups of individuals randomized together to the same intervention). In addition, we also included cross-over trials (that is, participants undergo more than one intervention); however, we only included these studies if the data were available separately for each group following the first treatment arm. For example, in a treatment (n = 50) versus control (n = 50) two-group design we required the data for the first treatment arm (treatment group versus control) before the groups crossed over and the conditions were reversed rather than the overall combined values for all treatment values compared to all control values. The rationale for this decision was based on the belief that once a psychological intervention (for example, distraction, hypnosis) has been introduced and taught to participants, it is difficult to prevent participants from using these strategies themselves (for example, cognitive distraction techniques) even if they are then switched to a control condition. Lastly, we also included studies using repeated measures designs (for example, pain and distress outcomes assessed at various time points); however, in these situations we only included outcomes occurring during the needle procedure (pre-needle outcomes were not included). If outcomes during the needle procedure were not evaluated, we then selected the next proximal time point occurring closest to the completion of the procedure. If outcomes that assessed both during and following the needle-related procedure were reported, outcomes during the needle procedure were selected for inclusion.

6. Dealing with missing data

All included RCTs were reviewed to determine if the authors reported any missing data. We had originally proposed that data would not be presented for studies if more than 20% of the originally randomized participants withdrew; however this was not applicable to any of the retrieved studies.

In all situations where data necessary for data pooling were omitted from the published RCT (for example, means, standard deviations (SDs), groups sizes, CIs), attempts were made to contact the study authors to obtain these data. If that was not possible, statistical formulae identified in the Cochrane Handbook for Systematic reviews of Interventions for calculating missing data using other reported measures of variation were used (for example, obtaining standard deviations from standard errors, confidence intervals, t values, and P values). In situations in which the authors could not be contacted, did not respond to contact attempts, did not have these data available, or there were insufficient data available to compute the necessary calculations, these studies or the outcomes with the missing data were excluded from this review.

To be consistent with authors’ reporting, we included the number of participants per group identified in the study results sections. When not otherwise specified by the authors, we assumed that there were no study dropouts and used the reported group sizes in the meta-analyses. Initially we intended to conduct all analyses using intention-to-treat (ITT) analyses. ITT analyses include all participants enrolled in the study including those who were lost to follow-up or dropped out. Given that the majority of RCTs did not specifically identify whether ITT analyses were used and did not consistently report whether there were any participant dropouts, ITT analyses could not be performed.

7. Assessment of heterogeneity

For each outcome combining the effects of two or more studies, we calculated heterogeneity using both the Chi2 test and the I2 statistic. Given that Chi2 tests often have low statistical power, a type 1 error level of 0.10 was employed for rejecting the null hypothesis of homogeneity as opposed to the more traditional type 1 error level of 0.05. While Chi2 tests are useful for identifying whether heterogeneity is present, it has been argued that there will always be some level of heterogeneity in meta-analyses given the clinical and methodological diversity (Higgins 2011). The I2 statistic shifts the focus away from whether heterogeneity is present and provides a measure of inconsistency across studies to assess the impact of heterogeneity on the meta-analysis (Higgins 2011). I2 is expressed as a percentage from 0 to 100, and the Cochrane Handbook for Systematic Reviews of Interventions suggests the following rough interpretation guide: 0 to 40%, might not be important; 30% to 60%, may represent moderate heterogeneity; 50% to 90%, may represent substantial heterogeneity; and 75% to 100% represents considerable heterogeneity. The reason for some of the overlap in ranges is because the importance of I2 depends on several other factors such as the magnitude and direction of effects, as well as the strength of evidence for the heterogeneity (for example, the P value for the Chi2 test or the confidence interval for the I2 statistic). In cases where statistically significant heterogeneity was detected, the data were still pooled; however, these results should be interpreted with caution. Given that there was significant heterogeneity for several of the analyses, results were analysed using a random-effects model. When possible, attempts were made to explore the reasons for the heterogeneity. We chose only to report I2 values in the text of the results section but both the I2 statistics and Chi2 tests are depicted in the forest plot figures.

8. Assessment of reporting biases

In order to help overcome publication bias in both the original and updated review, we: (1) imposed no language barriers in our search, (2) contacted several list serves and researchers in the field of pediatric health and pain to request any published, unpublished, and in-progress studies, and (3) contacted the authors of all the studies with missing means, standard deviations, and cell sizes in attempts to retrieve these data. Of note, many studies included several outcome measures; however, in some situations authors only reported means and standard deviations when the group differences with respect to the intervention were significant, but not when group differences were not significant. We included any studies in the meta-analysis that provided completed results (that is, means, SDs, and cell sizes for both treatment and control groups) for at least one outcome measure. Information related to reporting biases is also captured in the Risk of bias tool used to code all of the included studies reported in this update (studies included from the original review were also coded for this update using this tool). Nine of the studies included in this review had authors who responded to our requests and provided clarification or missing data (Balan 2009; Bisignano 2006; Caprilli 2007; Cavender 2004; Gupta 2006; Kleiber 2001; Liossi 1999; McCarthy 2010; Sinha 2006; Wint 2002).

9. Data synthesis

SMDs using a random-effects model for each of the above subcategories were calculated when the necessary data were available. Interventions were considered efficacious when the SMD and both anchors of the CI fell in the negative range. In the original review, we limited the main analyses to only RCTs but included quasi-randomized trials in sensitivity analyses. Due to the limitations of quasi-randomized trials, we limited the analyses to only true RCTs for this review update and did not include the additional sensitivity analyses for quasi-randomized trials.

In situations where studies included more than one type of control condition, we selected the condition that was most similar to the intervention condition, with the only difference being non-administration of the specific intervention. Thus, if a study had three conditions comparing: (1) music with headphones, (2) headphones without music, and (3) no headphones or music, we would select the headphones without music condition as the appropriate control condition because it was most similar to the intervention but just did not include the active ingredient (that is, music). In addition, it was important to note that some control or standard care groups included some cognitive or behavioural techniques, or both. However, we decided a priori to continue to classify these as control conditions since they were determined to be part of standard care and were conceptualized as control conditions by the study authors. In addition, and as noted above, if the control condition included a pharmacological component (for example, lidocaine and prilocaine eutectic mixture (EMLA), a cream used for local anaesthesia), this was still conceptualized as a control condition provided that the intervention group also received the same pharmacological component plus a psychological intervention. The implications of these types of control conditions are further explored in the discussion section of this review.

Consistent with the original review, when a single study provided more than one observer rating of the same construct (for example, both parent and nurse VAS ratings of child pain) or more than one behavioural measure for the same construct (for example, CAMPIS and OSBD measures to assess distress), these measures were pooled using statistical formulae recommended by The Cochrane Collaboration for combining means and SDs. This was done in order to be able to summarize the large amount of data reported in these studies. The formulae we used to pool means and SDs were the following: pooled mean = [(mean1 x N1) + (mean2 x N2) / (N1 + N2)] and pooled SD = square root of [SD12 (N1 - 1) + SD22 (N2 - 1)] / N1 + N2 -2.

As previously indicated, for studies that included outcomes for numerous time points we restricted our analyses to the measurement occurring during the procedure or, if that was not provided, we used the first post-procedure measurement. For example, if a study included procedural measures (taken during the needle) and post-procedural measures (taken after the needle), we included only the former in our analyses. For studies that included only post-needle measures but provided them at several time points (for example, immediately after needle, one minute later, five minutes later), we included the first measure or the outcome assessed as soon as possible following the needle. Pre-procedural measures of pain or distress were not analysed as the focus of this review was on pain and distress reduction during needle procedures.

10. Subgroup analysis and investigation of heterogeneity

As with the original review, subgroup analyses were limited to analysing each category of psychological intervention separately (for example, distraction RCTs, hypnosis RCTs, etc) as the interventions were considered too qualitatively distinct to combine, and overall analyses including all RCTs would not be as meaningful. In addition, as mentioned above, within each intervention category analyses were broken down by outcome category (pain versus distress outcomes) and within each of those categories they were further broken down by outcome measure (that is, self-report, observer-report, behavioural rating scales, and physiological interventions). Physiological outcomes were further analysed separately as they represented distinct functions or processes (for example, heart rate versus blood pressure). For all outcomes, the Chi2 test and I2 statistic of heterogeneity were carried out as previously described.

11. Sensitivity analysis

In our original review, we were unable to conduct all of the sensitivity analyses that we proposed due to insufficient data reported within and across studies, as well as the small number of studies within each intervention category. The main sensitivity analyses we conducted in the original review involved comparing the study results when quasi-randomized trials were added to the analyses. However, in order to strengthen the methodological quality of the findings for this updated review, we limited the included trials to only true RCTs that explicitly stated that true random assignment was conducted. As a result, the four studies with alternating assignment included in the sensitivity analyses of the original review were omitted from this updated review (Christiano 1996; MacLaren 2005; Manne 1990; Sparks 2001).

Results

Description of studies

Results of the search

Three electronic database searches were conducted: one for the original review (February 2005) and three for the updated review (December 2010, March 2012, March 2013). In the original review (Uman 2006; Uman 2008), 29 papers representing 28 separate studies were included. Of these, four were excluded from this review update because they did not report adequate randomization procedures in the paper (Cohen 1997; Cohen 2001; Cohen 2002; French 1994) and three were excluded because they were unpublished dissertation theses (Krauss 1996; Posner 1998; Zabin 1982). Of note, the Cohen 2001 (Cohen 2001) study was listed in the original review as Cohen 1999 (Cohen 1999) because both studies reported on the same sample; however, it was only counted as one study. Thus, a total of 21 studies from the original review were included in this update.

We initiated an updated search of the six databases from 2005 (inclusive) onwards in December 2010, yielding a total of 1338 abstracts which were reviewed. To account for the time taken to review these abstracts and work on other components of this review, we also conducted searches of the databases in March 2012 and March 2013 to identify any new studies published since December 2010. These latter two searches yielded an additional 639 abstracts. A total of 1977 abstracts were reviewed for this review update. Of these abstracts, 90 studies were identified as potentially meeting the inclusion criteria; however two of these studies were previously identified and included in our original review (Liossi 2006; Tak 2006) and one study was not identified in the original review search (Klingman 1985). Not accounting for the two studies already included in our original review (Liossi 2006; Tak 2006), this resulted in 88 studies identified in these updated searches that were reviewed in full based on their abstracts.

Our original search retrieved one non-English study reported in Portuguese, which was translated into English (Santos 1999). Our updated search retrieved two non-English studies reported in Farsi (Shahabi 2007; Vosoghi 2010), which needed to be reviewed in full. We obtained the assistance of a translator recommended by The Cochrane Collaboration who confirmed that one of these studies met our inclusion criteria (Vosoghi 2010). He then completed the data extraction form and Risk of bias tool for this study. In reviewing this study, he also identified an additional study in Farsi which potentially met our inclusion criteria (Alavi 2005). The two studies (Alavi 2005; Shahabi 2007) were excluded because they employed cross-over designs and data were not available pre-crossover, such that the studies could not be assessed as RCTs. In addition, our updated search identified two studies in German (Hoffman 2011; Kammerbauer 2011) and two in Italian (Bufalini 2009; Lessi 2011), which we had informally reviewed by researchers fluent in these languages; however, none of these studies met our inclusion criteria. One of these studies was excluded because the groups received general anesthesia or conscious sedation (Bufalini 2009) and the other three were excluded because they were not true RCTs (Hoffman 2011; Kammerbauer 2011; Lessi 2011). In total, of the 88 studies identified from these updated searches, 18 studies met our inclusion criteria and provided the data necessary for data pooling.

Included studies

Overall, this updated review included 21 studies from the original review (Blount 1992; Cassidy 2002; Cavender 2004; Chen 1999; Eland 1981; Fanurik 2000; Fowler-Kerry 1987; Gonzalez 1993; Goodenough 1997; Harrison 1991; Katz 1987; Kleiber 2001; Kuttner 1987; Liossi 1999; Liossi 2003; Liossi 2006; Press 2003; Tak 2006; Tyc 1997; Vessey 1994; Wint 2002) in addition to 18 studies from the updated searches from December 2010, March 2012, and March 2013 (Balan 2009; Bellieni 2006; Bisignano 2006; Caprilli 2007; Gold 2006; Gupta 2006; Huet 2011; Inal 2012; Jeffs 2007; Kristjansdottir 2010; Liossi 2009; McCarthy 2010; Nguyen 2010; Noguchi 2006; Sinha 2006; Vosoghi 2010; Wang 2008; Windich-Biermeier 2007) for a total of 39 studies (N = 3584 participants) reported in this updated review and meta-analysis.

Of the 39 included studies, most had intervention arms examining distraction only (n = 20), followed by hypnosis (n = 7), CBT-combined (n = 4), parent coaching plus child distraction (n = 3), suggestion only (n = 3), preparation and information (n = 2), virtual reality (n = 2); and memory alteration, parent positioning plus child distraction, blowing out air, and distraction plus suggestion (n = 1 each). Needle procedures varied and included venipuncture (n = 13), IV insertion (n = 7), immunization (n = 6), lumbar puncture (n = 5), bone marrow aspiration (n = 2); and intramuscular injection, local dental anesthetic, injection for allergy testing, laceration repair (n = 1 each). Additionally, participants in one study received either a venipuncture or IV insertion, and in another study they received bone marrow aspiration or lumbar puncture. Included studies also varied significantly in the age of recruited participants. The majority of studies (n = 22) focused on preschool (two to five years old) or school-aged children only (that is, six to 12 years old). Two studies included preschoolers and up to age 13 years. Fourteen studies recruited a wide age range of participants crossing preschool, school age, and adolescence (that is, anywhere from two to 19 years old). Only one study focused exclusively on adolescents (that is, 13 to 15 years old), which examined distraction. Interventions involving parent coaching or parent positioning combined with child distraction generally included preschool or school-aged children only, with the exception of one study which included children and adolescents (that is, 5 to 18 years old). Otherwise, types of interventions examined were distributed across the age ranges. All studies included both boys and girls, with three studies not reporting the sex of participants. Please refer to the 'Characteristics of included studies' table for additional detail, including the intervention and control conditions for each of these studies. For consistency, these are described using the authors' wording provided in published reports.

Excluded studies

Of the 188 studies identified and reviewed in full in the original review, 51 were excluded because they did not meet all of the inclusion criteria or failed to provide the data necessary for data pooling. Furthermore, as noted above, eight papers representing seven studies that were included in the original review were excluded from this review update because they did not report adequate randomization procedures in the paper or they were unpublished dissertation theses (Cohen 1997; Cohen 1999; Cohen 2001; Cohen 2002; French 1994; Krauss 1996; Posner 1998; Zabin 1982). Thus a total of 58 studies identified in the original review search were excluded in this update. Of the 88 studies identified and reviewed in full for this review update, 70 were excluded because they did not meet all of the inclusion criteria or did not report data necessary for data pooling. Thus a total of 128 studies from the original and updated searches were excluded after the full articles were reviewed. Reasons for exclusion are provided below as well as in the ‘Characteristics of excluded studies’ table.

Primary reasons for exclusion fell into the following categories:

Risk of bias in included studies

All of the 39 studies included in this review were coded using seven ‘Risk of bias’ categories, which included: 1) random sequence generation (selection bias), 2) allocation concealment (selection bias), 3) incomplete outcome data addressed (attrition bias), 4) free of selective reporting, 5) free of other bias, 6) blinding of participants and personnel (performance bias), and 7) blinding of outcome assessment (detection bias). Risk of bias results are depicted in Figure 1 and Figure 2. For random sequence generation, 15 of the studies were rated as having a low risk of bias, none were rated as having a high risk of bias, and 24 were rated as unclear. For allocation concealment, two of the studies were rated as having a low risk of bias, seven were rated as having a high risk of bias, and 30 were rated as unclear. For incomplete outcome data addressed, 30 of the studies were rated as having a low risk of bias, three were rated as having a high risk of bias, and six were rated as unclear. For free of selective reporting, one of the studies was rated as having a low risk of bias, 16 were rated as having a high risk of bias, and 22 were rated as unclear. For free of other bias, five of the studies were rated as having a low risk of bias, 21 were rated as having a high risk of bias, and 13 were rated as unclear. For blinding of participants and personnel, none of the studies were rated as having a low risk of bias, 37 were rated as having a high risk of bias, and two were rated as unclear. This result was expected given that it is not typically feasible to blind participants and personnel when conducting psychological interventions. However, we decided to code this item as we did not want to miss any studies where they may have been able to achieve blinding through creative methodology. For example, in theory, a study could achieve blinding of participants and personnel if the intervention involved parenting coaching or training in the use of distraction whereby participants (children receiving the injection) and personnel (nurses administering the injection) were unaware of the intervention. For blinding of outcome assessment, one of the studies was rated as having a low risk of bias, 36 were rated as having a high risk of bias, and two were rated as unclear. Again, although it is rare and challenging to achieving blinding of outcomes for psychological interventions, it is also possible. For example, if a study assessed an intervention involving nurse coaching or training in the use of distraction whereby parents and children were not made aware that distraction was being used as an intervention, and if the outcomes assessed were only completed by the children and parents, this study would achieve blinding of outcome assessment. Another example could involve a situation in which observer ratings are conducted based on a video recording of the needle procedure where the observer is blind to the intervention used and the type of intervention received is not discernible from the video.

Figure 1.

Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies.

Figure 2.

Risk of bias summary: review authors' judgments about each risk of bias item for each included study.

All of the 21 analyses reported below were assessed for heterogeneity. Of these 20 analyses: five had I2 values of 0% suggesting that heterogeneity might not be important; one had an I2 value below 30%, one had an I2 value between 30% and 50%, which may represent moderate heterogeneity; 11 had I2 values between 50% and 90% inclusive, which may represent substantial heterogeneity; and three had I2 scores above 90%, which indicated considerable heterogeneity.

Effects of interventions

Distraction

As with our original review, the most evidence in terms of number of published RCTs existed for the efficacy of distraction on self-reported pain. In total, there were 19 included studies examining the effects of distraction, although one of the studies (Bellieni 2006) involved two distraction groups using different strategies. The distraction techniques in these studies involved: listening to music (n = 5) (Balan 2009; Caprilli 2007; Kristjansdottir 2010; Nguyen 2010; Press 2003), watching cartoons (n = 4) (Bellieni 2006; Cassidy 2002; Tak 2006; Wang 2008), playing with a toy (n = 2) (Vessey 1994; Vosoghi 2010), non-procedural talk (n = 1) (Gonzalez 1993), squeezing a rubber ball (n = 1) (Gupta 2006), using cards with questions on them (n = 1) (Inal 2012), listening via earphones to stories being sung or read (n = 1) (Noguchi 2006), mother distraction including speaking, caressing, and soothing (n = 1) (Bellieni 2006), or a combination or selection of various distractors such as toys, books, cartoons, games, or music (n = 4) (Fanurik 2000; Jeffs 2007; Kuttner 1987; Sinha 2006). Thus, distraction interventions varied widely regarding the degree of passive or active involvement of the child, parental, or health professional involvement, or opportunity for the child to choose a distractor. Of these 19 studies examining distraction, the needle procedures included venipuncture or blood draw only (n = 8) (Balan 2009; Bellieni 2006; Caprilli 2007; Inal 2012; Press 2003; Tak 2006; Vessey 1994; Wang 2008), immunization or injection (n = 4) (Cassidy 2002; Gonzalez 1993; Kristjansdottir 2010; Noguchi 2006), IV insertion (n = 2) (Fanurik 2000; Vosoghi 2010), laceration repair (n = 1) (Sinha 2006), venipuncture via venous cannulation (n = 1) (Gupta 2006), allergy testing involving injection (n = 1) (Jeffs 2007), bone marrow aspiration (n = 1) (Kuttner 1987), and lumbar puncture (n = 1) (Nguyen 2010). Although the age ranges across the studies were quite broad and varied considerably, all of the studies included children 12 years and younger as part of the sample with the exception of one study (Kristjansdottir 2010), which only examined adolescents aged between 13 and 15 years. Of the remaining 18 studies that included children 12 and under, five of these also included adolescents aged up to 18 years (Caprilli 2007; Fanurik 2000; Jeffs 2007; Press 2003; Sinha 2006) while five studies only included children seven years and younger (Cassidy 2002; Gonzalez 1993; Kuttner 1987; Noguchi 2006; Vosoghi 2010). The variance in age ranges between and within studies and variability in type of needle procedures limits our ability to make age- or procedure-specific conclusions or recommendations.

Nineteen studies with a total of 1759 participants were entered into the analysis of the effects of distraction on self-reported pain, resulting in a SMD of -0.61 (95% CI -0.91 to -0.32) and an I2 of 88%. This effect was significant (Z = 4.08, P < 0.0001) (Analysis 1.1). Five studies with a total of 447 participants were entered into the analysis of the effects of distraction on observer-reported pain, resulting in a SMD of -0.87 (95% CI -1.75 to 0.02) and an I2 of 94%. This effect was marginally significant (Z = 1.92, P = 0.05) (Analysis 1.2). Three studies with a total of 286 participants were entered into the analysis of the effects of distraction on self-reported distress, resulting in a SMD of -0.66 (95% CI -1.37 to 0.06) and an I2 of 87%. This effect was not significant (Z = 1.79, P = 0.07) (Analysis 1.3). Two studies with a total of 363 participants were entered into the analysis of the effects of distraction on observer-reported distress, resulting in a SMD of -1.15 (95% CI -2.73 to 0.42) and an I2 of 97%, suggesting there is considerable heterogeneity in this analysis. This effect was not significant (Z= 1.44, P = 0.15) (Analysis 1.4). Two studies with a total of 152 participants were entered into the analysis of the effects of distraction on behavioural measures of pain, resulting in a SMD of -0.15 (95% CI -0.69 to 0.40) and an I2 of 62%. This effect was not significant (Z = 0.53, P = 0.59) (Analysis 1.5). Five studies with a total of 254 participants were entered into the analysis of the effects of distraction on behavioural measures of distress, resulting in a SMD of -0.30 (95% CI -0.76 to 0.16) and an I2 of 63%. This effect was not significant (Z = 1.28, P = 0.20) (Analysis 1.6). Two studies with a total of 112 participants were entered into the analysis of the effects of distraction on the physiological measure of heart rate, resulting in a SMD of -0.70 (95% CI -1.08 to -0.32) and an I2 of 0%. This effect was significant (Z = 3.58, P = 0.0003) (Analysis 1.7). Two studies with a total of 112 participants were entered into the analysis of the effects of distraction on the physiological measure of oxygen saturation, resulting in a SMD of 0.60 (95% CI 0.22 to 0.98) and an I2 of 0%. This effect was significant (Z = 3.10, P = 0.002) (Analysis 1.8). There was only one study that could be analysed for the effects of distraction on the physiological measures of respiratory rate, systolic blood pressure, and diastolic blood pressure (Nguyen 2010), therefore no additional conclusions could be drawn. Sample size, means, and SDs for these outcomes are available in Table 2.

Table 2. Means and standard deviations for outcomes from single trials
InterventionOutcomeStudyTreatmentControl
   NMean (SD)NMean (SD
DistractionPhysiological measure - Respiratory rate Nguyen 20102025.1 (3.6)2028.5 (3.86)
 Physiological measure - Systolic BP Nguyen 20102097.1 (8.57)20105.6 (15.97)
 Physiological measure - Diastolic BP Nguyen 20102065.2 (6.83)2069.8 (11.67)
HypnosisObserver-reported distress Katz 1987173 (0.9)193.3 (0.6)
 Behavioural measure - Pain Huet 2011141.07 (1.05)152.86 (2.16)
Preparation/InformationObserver-reported pain Harrison 1991501.89 (1.27)502.81 (1.11)
 Observer-reported distress Harrison 1991502.43 (1.62)503.17 (1.3)
 Behavioural measure - Distress Tak 2006262.64 (1.1)282.37 (1.12)
 Physiological measure - Pulse rate Harrison 19915084.6 (8.6)5088.6 (8.3)
Memory AlterationSelf-reported pain
(during procedure change score)
Chen 199915-0.06 (3.9)9-0.02 (3.2)
 

Observer-reported pain

(during procedure change score)

Chen 19992004. (3.1)22-0.1 (1.8)
 

Observer-reported distress

(during procedure change score)

Chen 199925-0.2 (2.6)25-0.5 (1.9)
 

Behavioural measure - Distress

(during procedure change score)

Chen 199925-0.62 (3.7)25-0.48 (2.0)
 

Physiological measure - Heart rate

(during procedure change score)

Chen 1999240.1 (26.9)20-4.9 (21.8)
 

Physiological measure - Cortisol

(during procedure change score)

Chen 1999220.01 (0.18)220.01 (0.2)
 

Physiological measure - Systolic BP

(during procedure change score)

Chen 199923-0.5 (11.8)19-5.4 (7.9)
 

Physiological measure - Diastolic BP

(during procedure change score)

Chen 199923-4.1 (10.9)192.9 (10.2)
Parent Coaching plus Child DistractionSelf-reported distress Windich-Biermeier 2007220.36 (0.9)280.54 (1.04)
 Physiological measure - Cortisol responsivity McCarthy 201011523.4 (7.9)12350.8 (9.4)
Parent Position plus Child DistractionSelf-reported pain Cavender 2004202.3 (1.87)232.74 (1.63)
 Self-reported distress Cavender 2004202.15 (1.81)232.74 (1.86)
 Observer-reported distress Cavender 2004201.24 (1.3)232.34 (1.72)
 Behavioural measure - Distress Cavender 20042013.7 (7.83)2316.39 (8.81)
SuggestionSelf-reported distress Goodenough 1997390.7 (1.1)391.1 (1.3)
 Observer-reported pain Goodenough 1997390.9 (1.6)391.7 (2.3)
 Observer-reported distress Eland 1981101.8 (0.71)101.8 (0.79)
Blowing Out AirSelf-reported pain Gupta 2006251.24 (1.3)254 (1.32)
Distraction plus SuggestionSelf-reported pain Fowler-Kerry 1987401.07 (1.02)801.78 (1.14)

Hypnosis

As with our original review, of all of the interventions assessed hypnosis had the largest significant effect sizes across several outcomes. Five studies with a total of 176 participants were entered into the analysis of the effects of hypnosis on self-reported pain, resulting in a SMD of -1.40 (95% CI -2.32 to -0.48) and an I2 of 85%. This effect was significant (Z = 2.97, P = 0.003) (Analysis 2.1). Five studies with a total of 176 participants were entered into the analysis of the effects of hypnosis on self-reported distress, resulting in a SMD of -2.53 (95% CI -3.93 to -1.12) and an I2 of 91%. This effect was significant (Z = 3.53, P = 0.0004) (Analysis 2.2). Six studies with a total of 193 participants were entered into the analysis of the effects of hypnosis on behavioural measures of distress, resulting in a SMD of -1.15 (95% CI -1.76 to -0.53) and an I2 of 71%. This effect was significant (Z = 3.66, P = 0.0003) (Analysis 2.3). There was only one study that could be analysed for the effects of hypnosis on either observer-reported distress (Katz 1987) or behavioural measures of pain (Huet 2011), therefore no additional conclusions could be drawn. Sample size, means, and SDs for these outcomes are available in Table 2.

Preparation and information

Two studies with a total of 154 participants were entered into the analysis of the effects of preparation and information on self-reported pain, resulting in a SMD of -0.22 (95% CI -1.20 to 0.76) and an I2 of 88%. This effect was not significant (Z = 0.43, P = 0.66) (Analysis 3.1). There was only one study that could be analysed for the effects of preparation and information on observer-reported pain, observer-reported distress, and the physiological measure of pulse rate (Harrison 1991), as well as only one study for behavioural measures of distress (Tak 2006). Therefore no additional conclusions could be drawn. Sample size, means, and SDs for these outcomes are available in Table 2.

Virtual reality

Two studies with a total of 50 participants were entered into the analysis of the effects of virtual reality on self-reported pain, resulting in a SMD of -0.23 (95% CI -0.79 to 0.33) and an I2 of 0%. This effect was not significant (Z = 0.80, P = 0.42) (Analysis 4.1).

Combined Cognitive Behavioural Intervention/Treatment (CBT)

The interventions in this category of cognitive behavioural interventions were heterogeneous as they involved different combinations of cognitive and behavioural components. Three studies with a total of 250 participants were entered into the analysis of the effects of CBT on self-reported pain, resulting in a SMD of -0.59 (95% CI -1.62 to 0.44) and an I2 of 86%. This effect was not significant (Z = 1.12, P =0.26) (Analysis 5.1). Three studies with a total of 105 participants were entered into the analysis of the effects of CBT on self-reported distress, resulting in a SMD of -0.50 (95% CI -1.08 to 0.07) and an I2 of 47%. This effect was not significant (Z = 1.72, P = 0.08) (Analysis 5.2). Two studies with a total of 84 participants were entered into the analysis of the effects of CBT on observer-reported distress, resulting in a SMD of 0.04 (95% CI -0.87 to 0.95) and an I2 of 75%. This effect was not significant (Z = 0.08, P = 0.93) (Analysis 5.3). Lastly, four studies with a total of 164 participants were entered into the analysis of the effects of CBT on behavioural measures of distress, resulting in a SMD of -0.54 (95% CI -1.16 to 0.09) and an I2 of 71%. This effect was not significant (Z = 1.69, P = 0.09) (Analysis 5.4).

Parent coaching + child distraction

Three studies with a total of 612 participants were entered into the analysis of the effects of parent coaching plus child distraction on self-reported pain, resulting in a SMD of 0.06 (95% CI -0.19 to 0.31) and an I2 of 24%. This effect was not significant (Z = 0.46, P = 0.65) (Analysis 6.1). Two studies with a total of 581 participants were entered into the analysis of the effects of parent coaching plus child distraction on observer-reported distress, resulting in a SMD of -0.04 (95% CI -0.21 to 0.12) and an I2 of 0%. This effect was not significant (Z = 0.52, P = 0.60) (Analysis 6.2). Three studies with a total of 635 participants were entered into the analysis of the effects of parent coaching plus child distraction on behavioural measures of distress, resulting in a SMD of -0.36 (95% CI -0.97 to 0.25) and an I2 of 83%. This effect was not significant (Z = 1.16, P = 0.25) (Analysis 6.3). There was only one study that could be analysed for the effects of parent coaching plus child distraction on either self-reported distress (Windich-Biermeier 2007) or the physiological measure of cortisol responsivity (McCarthy 2010), therefore no conclusions could be drawn. Sample size, means, and SDs for these outcomes are available in Table 2.

Suggestion

Three studies with a total of 218 participants were entered into the analysis of the effects of suggestion on self-reported pain, resulting in a SMD of -0.13 (95% CI -0.40 to 0.15) and an I2 of 0%. This effect was not significant (Z = 0.90, P = 0.37) (Analysis 7.1). There was only one study that could be analysed for the effects of suggestion on observer-reported pain and self-reported distress (Goodenough 1997), as well as only one study for observer-reported distress (Eland 1981); therefore no additional conclusions could be drawn. Sample size, means, and SDns for these outcomes are available in Table 2.

Parent positioning + child distraction

Only one study provided outcome measures for the effects of parent positioning plus child distraction on pain and distress (Cavender 2004), therefore no conclusions could be drawn. Sample size, means, and SDs for these outcomes are available in Table 2.

Memory alteration

Only one study provided outcome measures for the effects of memory alteration on pain and distress (Chen 1999), therefore no conclusions could be drawn. Sample size, means, and SDs for these outcomes are available in Table 2.

Blowing out air

The one study analysing this intervention in the original review was excluded from this update because of our revised inclusion criteria (that is, the allocation procedure not described as truly random in the study). There was only one additional study analysing this intervention identified from the updated searches (Gupta 2006), therefore no conclusions could be drawn. Sample size, means, and SDs for these outcomes are available in Table 2.

Distraction + suggestion

Only one study provided outcome measures for the effects of distraction plus suggestion on pain (Fowler-Kerry 1987), therefore no conclusions could be drawn. Sample size, means, and SDs for these outcomes are available in Table 2.

Nurse coaching + distraction

The two studies assessing nurse coaching plus distraction that were included in the original review were excluded from this review because of our revised inclusion criteria, explained above (that is, the allocation procedure was not described as truly random in the study). Since no studies assessing this intervention category were identified from our updated search strategy, there were no available data to assess the efficacy of this intervention. Please refer to the original review for more information on our previous findings and conclusions prior to conducting this updated review (Uman 2006; Uman 2008).

Videotaped modelling + parent coaching

The one study assessing videotaped modelling plus parent coaching included in the original review was excluded from this review because of our revised inclusion criteria (that is, non-published dissertation study). Since no studies assessing this intervention category were identified from our updated search strategy, there were no available data to assess the efficacy of this intervention.

Filmed Modeling

The one study assessing filmed modelling that was included in the original review was excluded from this review because of our revised inclusion criteria (that is, non-published dissertation study). Since no studies assessing this intervention category were identified from our updated search strategy, there were no available data to assess the efficacy of this intervention.

Discussion

Summary of main results  

This review synthesizes the results of 39 RCTs; 21 identified from the original review (Uman 2006) and an additional 18 identified from this update. By including only true randomized controlled trials published in peer-reviewed journals, this review offers a rigorous systematic examination of the efficacy of psychological interventions for reducing needle-related pain and distress in children and adolescents. Our results show strong evidence supporting the efficacy of distraction and hypnosis. More specifically, trials support the use of distraction for reducing pain, and hypnosis for the reduction of both pain and distress. Despite the availability of two to four RCTs for each type of intervention, no evidence was available to support the efficacy of preparation and information, combined CBT, parent coaching plus distraction, suggestion, or virtual reality for reducing children's pain and distress. Our original review (Uman 2006) identified sufficient evidence supporting combined CBT; however, due to the more stringent inclusion criteria of this update, three trials examining combined CBT were removed (Cohen 1997; Cohen 2002; Posner 1998) and two new trials (Bisignano 2006; Wang 2008) were identified in the updated searches. Given this new evidence, the efficacy of combined CBT was no longer supported. No conclusions could be made about the efficacy of memory alteration, parent positioning plus distraction, blowing out air, or distraction plus suggestion due to the availability of single trials only in those areas.

Although this review continues to provide strong evidence for the efficacy of distraction as a whole, significantly variability was noted in the distraction methods described in the 20 trials reporting on distraction interventions. We are still lacking clear evidence to identify whether the type of distraction influences its efficacy across child development, and with different needle procedures. Although the type of distraction varies, the majority of the evidence for distraction to date is with school-aged children (that is, ages six to 12 years), but it is supported by studies including children from two to 19 years old. Future studies clarifying these distinctions are necessary to empirically inform more targeted analyses and treatment recommendations.

Overall, hypnosis had the largest effect sizes for reducing pain and distress during needle-related procedures; however, it is important to note that the majority of these trials have been published by the same research group. As such, this raises questions about the generalizability and efficacy of this approach when administered by different providers in different pediatric settings. Future research should assess the efficacy of hypnosis in different settings, including multi-site trials with multiple therapists, in order to provide additional support for the generalizability of these intervention approaches. Furthermore, hypnotisability appears related to the magnitude of treatment benefit (Liossi 2003). Therefore, hypnosis may not be effective for children who have low hypnotisability. This highlights the important point of needing to not only examine intervention efficacy overall but also to consider and evaluate the match between intervention type and child characteristics.

Overall completeness and applicability of the evidence  

This review enables identification of current trends in pediatric acute pain research. Since the publication of the original review, we have noted a decrease in use of classic no-treatment control groups, defined as the absence of psychological and pharmacological pain management, as well as the increased use of topical anesthetics as part of standard care. This is likely due, in part, to the dissemination of advances in pediatric pain management through publication and endorsement of clinical practice guidelines and position statements (Taddio 2010). Indeed, withholding topical anesthetics and non-pharmacological intervention in the face of a strong evidence base for their effectiveness is widely and accurately justified as unethical (Anderson 2005; World Medical Association 2008). However, this shift also has practical research implications. Comparison of interventions with other effective treatments will make it more difficult to detect treatment effects; as such, the field may need to apply new parameters in determining the degree of treatment efficacy (for example, non-inferiority trials). Furthermore, the use of topical anesthetics needs to be measured and controlled for in future trials as their use in standard care may vary, and they are not uniformly given to all children (Windich-Biermeier 2007; Wint 2002), thereby potentially contaminating the group of additional psychological interventions. While the decreased use of no-treatment control groups and increased use of topical anesthetics may reflect a trend towards increased use of evidence-based strategies, continued suboptimal acute pain assessment and management (Stevens 2012; Taddio 2009) suggests that this knowledge is not being widely translated into implementation by providers and families. While the results of this review provide information about research trends, it may not accurately represent what it being implemented in actual clinical practice around the world.

Although the results of this review are based on 39 trials, the vast majority of studies continue to investigate the efficacy of distraction. Rather than continuing to examine a mix of distractors, we argue that the field would benefit more from studies systematically comparing and dismantling the effective aspects of distraction techniques. For example, more recent trials have begun distinguishing between ‘active’ distraction, which engages more senses and requires more patient engagement (for example, playing a video game) versus 'passive' distraction where the patient is less actively involved (for example, watching television (TV)). This warrants further investigation as experimental research has shown that active or interactive (as compared to passive) virtual-reality based distraction was more efficacious for reducing pain in children (Dalhquist 2007). However, a systematic review of music therapy for painful medical procedures in children found that passive music therapy was as effective as active music therapy (Klassen 2008). Research is also needed to identify the impact of distraction novelty on intervention efficacy as it has been proposed that interventions involving novel materials or activities are more effective at capturing a child’s attention (Sinha 2006; Slifer 2002). Furthermore, the role of child preference or choice in distractors is also of interest given that older and younger children tend to select different distractors when given the choice (Sinha 2006; Windich-Biermeier 2007). A number of included trials involved parents in the distraction intervention (; Bellieni 2006 ; Blount 1992 ; Cavender 2004 ; Kleiber 2001 ; McCarthy 2010) whereas others did not (Gupta 2006 ; Jeffs 2007 ; Kristjansdottir 2010 ; Noguchi 2006 ; Tak 2006 ; Wang 2008). Future research should consider the potential impact of parental involvement on intervention delivery and efficacy, as parental presence alone is known to influence children’s behaviour during painful experiences regardless of parent behaviour (see Vervoort 2008; Vervoort 2011). Thus, although we can conclude overall that distraction is efficacious for reducing needle-related pain, our ability to differentiate which aspects of distraction are most efficacious remains limited.

Actual engagement of the parent or child, or both, in the distraction activity should also be routinely monitored in RCTs, as the effectiveness of a particular distractor may depend on the level of engagement or dose received. McCarthy and colleagues (McCarthy 2010) noted that some parents in their control group engaged naturally in distraction. In order to best identify the impact of distraction on needle-related pain and distress, they created three comparison groups based on the actual level of observed parent distraction during the intravenous line (IV) insertion, regardless of experimental group. This secondary analysis provided a more rigorous test of the impact that distraction had on child pain. While child engagement and successful use of distraction techniques are critical for making conclusions about efficacy, very few studies routinely assess and control for this important confounder.

Importantly, the age range of children included in the trials in this review varied greatly, making it difficult to determine which psychological interventions are most effective for different age ranges or developmental periods. Furthermore, few studies exclusively examined interventions in adolescents. Given the rapid developmental changes that take place from early childhood to late adolescence, it is likely that the efficacy of interventions vary based on developmental stage and maturity of the individual child. Indeed, self-management of needle-related pain and distress using evidence-based psychological interventions may be particularly important for older children and adolescents when immunizations are often given in school settings; reliance on parents decreases throughout development and the children increasingly rely on cognitive coping strategies. For example, children’s inclination towards the use of particular coping strategies changes across development, with research indicating that younger children tend to use more behavioural strategies, whereas older children and adolescents use more cognitive strategies (Skinner 2007). Future research should assess the relative efficacy of psychological interventions across development in order to inform treatment that matches and bolsters their effectiveness.

There was notable variability in the types of needle procedures represented in this review, including those that are expected to occur multiple times even among healthy children, such as immunizations. However, very few trials assessed the efficacy of psychological interventions over time and the maintenance of treatment gains. One notable exception was the work of Liossi and colleagues (Liossi 2009), who examined children’s use of hypnosis over the course of three needle-related procedures. In addition to examining change over time, the researchers examined pain and distress among children while they received therapist-guided hypnosis at an initial procedure and then again while they engaged in self-hypnosis during two subsequent procedures. This study highlights the importance of examining changes and maintenance of treatment gains within children over time, as well as the generalizability of interventions beyond individual providers.

Lastly, in addition to direct outcomes such as quantifications of pain and distress, it is also important to consider other relevant but indirect evidence. For example, it would be helpful for studies to assess child, caregiver, and health professional preference or beliefs about different intervention techniques, changes over time in the adoption of pain reduction and prevention strategies, data on needle pain prevention and relief in adult or animal studies, and expert opinions. Currently the Canadian Task on Preventative Care classifies the opinions of respected authorities based on clinical experience as level III (lowest rating) in terms of criteria for evaluating evidence, while evidence from RCTs is rated as level I (the highest rating) (Palda 2004). Additional evidence-based clinical practice guidelines for reducing childhood vaccination pain are also available and should be considered when conducting future studies in the area of acute pain (Taddio 2010).

Quality of the evidence  

To our knowledge, this review represents the largest and most up to date review of psychological interventions for needle-related pain and distress in children and adolescents, and includes a total of 39 RCTs comprising 3394 participants. The evidence supporting the efficacy of distraction and hypnosis for reducing children’s pain and distress is consistent across relevant included trials. Although the quality of evidence is limited by the many studies with high or unclear risk of bias for their outcomes, the 39 RCTs included in this review can be considered the most rigorous and well-reported studies in the field. An additional 128 studies were excluded due to insufficient rigour or inadequate reporting of findings for meta-analysis.

Assessment of risk of bias in trial design and reporting is critical as RCTs with unclear or high risk of bias have been associated with significantly larger treatment effects in RCTs with children and adults (Hartling 2009; Savovic 2012). Addressing incomplete outcome data was the domain with the greatest proportion of studies categorized as low risk of bias, although all trials showed the majority of bias domains as high or unclear risk. In particular, high risk of bias was most commonly found for blinding of participants and personnel, and blinding of outcome assessment. While there are few studies of psychological interventions where it is possible to blind study participants and personnel to the treatment condition, two of the included studies in this review (Goodenough 1997; McCarthy 2010) successfully blinded the observation coding of outcomes. Thus, while complete blinding of the patient or treatment administrator may not be feasible, we argue that researchers should use blind outcome coding whenever possible to reduce study bias, and that this can sometimes be achieved through careful study design.

Many trials had unclear risk of bias, particularly in the domains of random sequence generation, allocation concealment, and selective reporting. While this may expose real limitations in study design, it may alternatively reflect insufficient reporting of study methods and procedures in published manuscripts. However, exaggerated treatment effects have been shown in trials with inadequate or unclear random sequence generation, allocation concealment, or selective reporting (Chan 2004; Savovic 2012). This suggests that researchers should pay careful attention to these domains in study design and publication. Reporting of adequate sequence generation is the only risk of bias domain with notable improvement over the past 30 years of published RCTs in this area. Researchers should carefully follow the CONSORT guidelines (Moher 2001) when reporting randomized trials to ensure that details relevant to randomization, allocation, and blinding are adequately addressed.

Over half of the included trials had a high risk of other sources of bias. Potential sources of bias captured in this domain included concerns regarding the validity or reliability of measurement tools used to assess the outcomes of pain and distress as well as how and when outcomes were assessed (for example, using an unvalidated modification of a validated pain assessment tool). Other notable sources of potential bias included potential contamination of the control or experimental group (for example, venepunctures occurring in a group context and potential for distress contagion), baseline differences between groups, and small sample size resulting in the trial being underpowered to detect group differences. It is perhaps surprising that these issues continue to be quite common as their potential to lead to inaccurate estimates of treatment effects has been noted for many years (Moher 1994).

Potential biases in the review process  

Strengths of this review include the comprehensive and updated literature searches, the inclusion of non-English publications, and contacting authors when relevant data were missing from published reports. Despite these efforts, 21 studies were excluded solely because they did not provide sufficient data in published reports or via e-mail correspondence to allow for data pooling in the meta-analysis. This represents a source of bias as it resulted in a large number of RCTs that could not be adequately captured in our review. In order to limit the exclusion of trials, we included RCTs that provided full data for at least one outcome measure. However, this may pose an additional source of bias given that significant findings are sometimes more fully reported than non-significant findings. To minimize this, authors should include summary statistics (that is, means, SDs, cell sizes) for all assessed outcomes, regardless of study results. In keeping with other recently published Cochrane reviews and updates (for example, Eccleston 2012; Williams 2012a), we excluded unpublished dissertation studies. This may introduce bias by excluding some relevant studies and we recommend that dissertation authors submit their research to scientific journals to make their findings more accessible and ultimately help translate their research into practice.

Lastly, the timing of assessed pain and distress often varied across studies, sometimes assessed during the needle procedure while in other instances assessed at varying times post-procedure. In some cases, the timing of assessed pain and distress was not clearly reported. This variability in outcome assessments adds potential bias in comparisons across studies. We recommend the standard assessment of post-needle pain or distress immediately following the procedure (that is, as soon as the needle is removed). If studies wish to include additional post-needle measures, it would be helpful to consider establishing a maximum time gap between completion of the needle procedure and measurement of the outcome in order to reduce possible memory-based biases (Noel 2012).

Agreements and disagreements with other studies or reviews

To our knowledge, this is the most comprehensive updated review of this topic. However, other systematic reviews in related areas are available, which also support the efficacy of various psychological or non-pharmacological interventions for pediatric pain management. These include, and are not limited to, systematic reviews of psychological interventions for reducing the pain and distress of childhood immunizations (Chambers 2009), non-pharmacological interventions for infant procedural pain (Pillai-Riddell 2011a; Pillai-Riddell 2011b), music interventions for acute and chronic pain in children and adults (Cepeda 2010; Klassen 2008), psychological interventions for chronic or recurrent pain in children and adolescents (Eccleston 2009), and psychological therapies for sickle cell disease and pain (Anie 2012).

Authors' conclusions

Implications for practice

The results of this review suggest that youth, caregivers, and healthcare practitioners should use distraction techniques or hypnosis during needle procedures. Despite the significant variability in distraction interventions (for example, type of distractor, passive or active involvement of the child, and parent or nurse involvement), support is consistent for its efficacy in reducing pain from needle-related procedures. The most evidence is available for more common needle procedures (for example, venepuncture, immunization) and with children 12 years and younger, although support also exists for its use with adolescents. Hypnosis can be particularly helpful for more invasive needle procedures (for example, lumbar punctures) and for reducing both pain and distress; however, its application may be limited in practice given the reduced availability of health professionals trained in hypnosis. In addition to their efficacy in reducing pain and distress, these psychological interventions can also help empower children, adolescents, and their parents in being active agents in their own pain management, thereby facilitating generalizability across settings and time.

At present there is no evidence for the efficacy of any other psychological intervention, including preparation and information, combined CBT, parent coaching plus distraction, suggestion, or virtual reality, although more trials are needed. No conclusions could be made about additional interventions, such as memory alteration, parent positioning plus distraction, blowing out air, or distraction plus suggestion, as only one study examined each of these interventions. Of these interventions, it is likely that those including distraction would be most helpful (that is, parent coaching plus distraction, parent positioning plus distraction, and distraction plus suggestion).

Implications for research

(1) Types of interventions

It is our position that additional RCTs examining the effectiveness of distraction to a no-treatment or standard care control have limited value. Given the variety of distraction interventions described in the included studies, further research on distraction should compare different types of distractors (for example, active versus passive) and assess the developmental appropriateness of interventions, engagement and dose of the intervention, the impact of novelty, or distractor preference and selection. Despite the myriad of trials examining distraction, this review also identified a variety of psychological interventions that have been examined in only one or two RCTs to date. Several of these suggest promise (for example, preparation and information, blowing out air, distraction plus suggestion) with significant reductions in pain or distress, or both, in single trials; however, conclusions about their efficacy cannot be made at this time given the limited evidence available.

(2) Consideration of child age and development

There is a gap in our understanding of the efficacy of interventions across age ranges. Future trials should investigate potential age and developmental differences, following the standard age ranges provided by the Standards for Research (StaR) in Child Health initiative (toddlers and preschoolers two to four years, grade-schoolers five to 12 years, adolescents 13 to 19 years (Williams 2012b)). Furthermore, given the limited evidence specific to adolescents, it is critical for future trials to target that population given that children's coping preferences change across development (Skinner 2007) as does parental involvement, and needle procedures such as immunizations may occur in a variety of settings (for example, school-based immunization clinics (Kristjansdottir 2010)).

(3) Consideration of variability in needle procedures

Future trials should address our limited understanding regarding the efficacy of interventions for different needle procedures, particularly those that are more routine (for example, immunization, venepuncture) versus those that are considered more invasive (for example, lumbar puncture, bone marrow aspiration), as well as single event versus repeated or multiple needle procedures. In addition, it will be important to assess pain and distress scores at different stages of the procedure (for example, pre-procedure, during procedure, post-procedure, and at subsequent future procedures) to assess longer-term outcomes and to determine whether additional practice and exposure to psychological interventions lead to more optimal pain management.

(4) Improving trial quality and reporting

Although our research suggests that study quality and reporting have improved over time (Uman 2010), there remains substantial room for improvement as evidenced by the risk of bias scores reported in this review. Specifically, researchers should ensure true randomization procedures (for example, computer-generated random numbers) and concealment of random allocation, optimize blinding of study outcomes to the extent that is possible (for example, blind coders coding from videotapes), and ensuring adequate sample size for sufficient power to detect group differences. These details should be clearly reported in publications, in addition to thorough reporting of all outcomes and reasons for any withdrawals and dropouts. When selecting outcome measures, researchers should draw from efforts to standardize the use of the highest quality assessment tools, such as the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (PedIMMPACT) (McGrath 2008).

Acknowledgements

We wish to thank the many individuals who helped in the preparation of this updated review as well as the original review. First, we would like to thank all members of the Cochrane Pain, Palliative, and Supportive Care (PaPaS) team, particularly Anna Hobson, Jessica Thomas, Frances Fairman, Phil Wiffen, Yvonne Roy, Sylvia Bickley, Jane Hayes, and Chris Eccleston. We would also like to thank reference librarians Pam Parker, Tim Ruggles, Robin Parker, and Susan Klawansky for their invaluable assistance. We are also grateful to the advice and input of many others including: Kirk Magee, Stephen Morley, G Allen Finley, and Paula Forgeron. We sincerely thank all current and past members of the IWK Centre for Pediatric Pain Research who helped with this project including Leah Wofsy, Aimee Dort, Kelly Hayton, Crystal Holly, Jessica Ferguson, Sarah Peddle, and Darby Eakins. We are especially grateful to Javad Shahidi, Carl von Baeyer, Mirko Manchia, and Narjes Sadr Momtaz who screened non-English studies for us and, when necessary, conducted data extraction and risk of bias coding.

We would also like to thank the Dalhousie Cochrane Group and Pain in Child Health (PICH), a strategic training initiative of the Canadian Institutes of Health Research (CIHR), for their financial support. This review update would not have been possible without a Category A Grant from the IWK Health Centre awarded to LS Uman. Funding was also provided by an IWK Establishment Award to CT Chambers. CT Chambers and PJ McGrath are supported by Canada Research Chairs. LS Uman received financial support from the Natural Sciences and Engineering Council of Canada (NSERC), the Nova Scotia Health Research Foundation (NSHRF), and the Fonds de Reserche en Sante de Quebec (FRSQ; Quebec Health Research Foundation) while conducting the original review on which this update is based. Lastly, we wish to thank the many study authors whose studies contributed to this review, and who responded to our requests for additional data.

Data and analyses

Download statistical data

Comparison 1. Distraction
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Self-reported pain191759Std. Mean Difference (IV, Random, 95% CI)-0.61 [-0.91, -0.32]
2 Observer-reported pain5447Std. Mean Difference (IV, Random, 95% CI)-0.87 [-1.75, 0.02]
3 Self-reported distress3286Std. Mean Difference (IV, Random, 95% CI)-0.66 [-1.37, 0.06]
4 Observer-reported distress2363Std. Mean Difference (IV, Random, 95% CI)-1.15 [-2.73, 0.42]
5 Behavioral measures- Pain2152Std. Mean Difference (IV, Random, 95% CI)-0.15 [-0.69, 0.40]
6 Behavioral measures- Distress5254Std. Mean Difference (IV, Random, 95% CI)-0.30 [-0.76, 0.16]
7 Physiological measure - Heart Rate2112Std. Mean Difference (IV, Random, 95% CI)-0.70 [-1.08, -0.32]
8 Physiological measure - Oxygen Saturation2112Std. Mean Difference (IV, Random, 95% CI)0.60 [0.22, 0.98]
Analysis 1.1.

Comparison 1 Distraction, Outcome 1 Self-reported pain.

Analysis 1.2.

Comparison 1 Distraction, Outcome 2 Observer-reported pain.

Analysis 1.3.

Comparison 1 Distraction, Outcome 3 Self-reported distress.

Analysis 1.4.

Comparison 1 Distraction, Outcome 4 Observer-reported distress.

Analysis 1.5.

Comparison 1 Distraction, Outcome 5 Behavioral measures- Pain.

Analysis 1.6.

Comparison 1 Distraction, Outcome 6 Behavioral measures- Distress.

Analysis 1.7.

Comparison 1 Distraction, Outcome 7 Physiological measure - Heart Rate.

Analysis 1.8.

Comparison 1 Distraction, Outcome 8 Physiological measure - Oxygen Saturation.

Comparison 2. Hypnosis
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Self-reported pain5176Std. Mean Difference (IV, Random, 95% CI)-1.40 [-2.32, -0.48]
2 Self-reported distress5176Std. Mean Difference (IV, Random, 95% CI)-2.53 [-3.93, -1.12]
3 Behavioral measures- Distress6193Std. Mean Difference (IV, Random, 95% CI)-1.15 [-1.76, -0.53]
Analysis 2.1.

Comparison 2 Hypnosis, Outcome 1 Self-reported pain.

Analysis 2.2.

Comparison 2 Hypnosis, Outcome 2 Self-reported distress.

Analysis 2.3.

Comparison 2 Hypnosis, Outcome 3 Behavioral measures- Distress.

Comparison 3. Preparation and information
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Self-reported pain2154Std. Mean Difference (IV, Random, 95% CI)-0.22 [-1.20, 0.76]
Analysis 3.1.

Comparison 3 Preparation and information, Outcome 1 Self-reported pain.

Comparison 4. Virtual reality
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Self-reported pain250Std. Mean Difference (IV, Random, 95% CI)-0.23 [-0.79, 0.33]
Analysis 4.1.

Comparison 4 Virtual reality, Outcome 1 Self-reported pain.

Comparison 5. CBT-combined
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Self-reported pain3250Std. Mean Difference (IV, Random, 95% CI)-0.59 [-1.62, 0.44]
2 Self-reported distress3105Std. Mean Difference (IV, Random, 95% CI)-0.50 [-1.08, 0.07]
3 Observer-reported distress284Std. Mean Difference (IV, Random, 95% CI)0.04 [-0.87, 0.95]
4 Behavioral measures- Distress4164Std. Mean Difference (IV, Random, 95% CI)-0.54 [-1.16, 0.09]
Analysis 5.1.

Comparison 5 CBT-combined, Outcome 1 Self-reported pain.

Analysis 5.2.

Comparison 5 CBT-combined, Outcome 2 Self-reported distress.

Analysis 5.3.

Comparison 5 CBT-combined, Outcome 3 Observer-reported distress.

Analysis 5.4.

Comparison 5 CBT-combined, Outcome 4 Behavioral measures- Distress.

Comparison 6. Parent coaching + child distraction
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Self-reported pain3612Std. Mean Difference (IV, Random, 95% CI)0.06 [-0.19, 0.31]
2 Observer-reported distress2581Std. Mean Difference (IV, Random, 95% CI)-0.04 [-0.21, 0.12]
3 Behavioral measures- Distress3635Std. Mean Difference (IV, Random, 95% CI)-0.36 [-0.97, 0.25]
Analysis 6.1.

Comparison 6 Parent coaching + child distraction, Outcome 1 Self-reported pain.

Analysis 6.2.

Comparison 6 Parent coaching + child distraction, Outcome 2 Observer-reported distress.

Analysis 6.3.

Comparison 6 Parent coaching + child distraction, Outcome 3 Behavioral measures- Distress.

Comparison 7. Suggestion
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Self-reported pain3218Std. Mean Difference (IV, Random, 95% CI)-0.13 [-0.40, 0.15]
Analysis 7.1.

Comparison 7 Suggestion, Outcome 1 Self-reported pain.

Appendices

Appendix 1. MEDLINE search strategy

1   Needles/

2   (needle* or inject*).mp.

3   (immuni* or vaccin* or finger prick* or heel prick*).mp.

4   (lumbar puncture* or spinal tap*).mp.

5   (bone marrow adj (aspiration or biops*)).mp.

6   (intravenous or intra-venous or venepuncture* or venous cannulation*).mp.

7   (catheter adj5 insert*).mp.

8   (central line adj5 insert*).mp.

9   (local adj (analges* or anaesthe* or anesthe*)).mp.

10 (arterial adj (puncture or line*)).mp.

11 (artery adj5 puncture).mp.

12 (thoracocentesis or paracentesis).mp.

13 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12

14 Pain/

15 ((needle* or immuni* or vaccin* or inject* or procedure* or intervention*) adj5 (pain* or distress* or discomfort or fear* or fright* or anxious or anxiet*)).mp.

16 14 or 15

17 (rehears* or coping or verbal* encourage* or positiv* reinforce* or reward* or token* or self talk or selftalk* or stop signal* or structured attention).mp.

18 ((cognitive* or behaviour* or behavior*) adj5 (intervention* or therap* or distract*)).mp.

19 (((audiovisual or audio visual or visual*) and distract*) or movie* or television* or tv or game* or toy* or virtual reality or tactile* stimulat*).mp.

20 ((multisensory or multi-sensory) adj stimulation).mp.

21 Therapeutic Touch/

22 Relaxation/

23 Breathing Exercises/

24 Laughter Therapy/

25 exp Psychotherapy/

26 (desensiti* or relax* or therapeutic touch* or breathing exercise* or hypnosis or hypnoti* or hypnotherapy or image* or psychotherap*).mp.

27 (autogenic training or auto suggestion*).mp.

28 ((colour* or color* or music* or play) and (therap* or distract*)).mp.

29 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28

30 exp Child/

31 exp Infant/

32 exp Adolescent/

33 (child* or infant* or adolescent* or adolescence).mp.

34 30 or 31 or 32 or 33

35 13 and 16 and 29 and 34

key:

mp=title, original title, abstract, name of substance word, subject heading word, unique identifier

 

Appendix 2. PsycINFO search strategy

1   (needle* or inject*).mp.

2   (immuni* or vaccin* or finger prick* or heel prick*).mp.

3   (lumbar puncture* or spinal tap*).mp.

4   (bone marrow adj (aspiration or biops*)).mp.

5   (intravenous or intra-venous or venepuncture* or venous cannulation*).mp.

6   (catheter adj5 insert*).mp.

7   (central line adj5 insert*).mp.

8   (local adj (analges* or anaesthe* or anesthe*)).mp.

9   (arterial adj (puncture or line*)).mp.

10  (artery adj5 puncture).mp.

11  (thoracocentesis or paracentesis).mp.

12  1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11

13  Pain/

14  ((needle* or immuni* or vaccin* or inject* or procedure* or intervention*) adj5 (pain* or distress* or discomfort or fear* or fright* or anxious or anxiet*)).mp.

15  13 or 14

16  (rehears* or coping or verbal* encourage* or positiv* reinforce* or reward* or token* or self talk* or selftalk* or stop signal* or structured attention).mp.

17  ((cognitive* or behaviour* or behavior*) adj5 (intervention* or therap* or distract*)).mp.

18  (((audiovisual or audio visual or visual*) and distract*) or movie* or television* or tv or game* or toy* or virtual reality or tactile stimulat*).mp.

19  ((multisensory or multi-sensory) adj stimulation).mp.

20  exp relaxation therapy/

21  Relaxation/

22  exp psychotherapy/

23  (desensiti* or relax* or therapeutic touch* or breathing exercise* or hypnosis or hypnoti* or hypnotherapy or image* or psychotherap*).mp.

24  (autogenic training or auto suggestion*).mp.

25  ((colour* or color* or music* or play) and (therap* or distract*)).mp.

26  16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25

27  (child* or infant* or adolescent* or adolescence).mp.

28  12 and 15 and 26 and 27

key:

[mp=title, abstract, heading word, table of contents, key concepts]

Appendix 3. CENTRAL search strategy

#1   MeSH descriptor Needles, this term only

#2   needle* or inject*

#3   immuni* or vaccin* or (finger next prick*) or (heel next prick*)

#4   (lumbar next puncture*) or (spinal next tap*)

#5   bone next marrow next (aspiration or biops*)

#6   intravenous or intra-venous or venepuncture* or (venous next cannulation*)

#7   catheter near insert*

#8   (central next line) near insert*

#9   local next (analges* or anaesthe* or anesthe*)

#10  arterial next (puncture or line*)

#11  artery near puncture

#12  thoracocentesis or paracentesis

#13  (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12)

#14  MeSH descriptor Pain, this term only

#15  (needle* or immuni* or vaccin* or inject* or procedure* or intervention*) near (pain* or distress* or discomfort or fear* or fright* or anxious or anxiet*)

#16  (#14 OR #15)

#17  rehears* or coping or (verbal* next encourage*) or (positiv* next reinforce*) or reward* or token* or (self next talk*) or selftalk* or (stop next signal*) or (structured next attention)

#18  (cognitive* or behaviour* or behavior*) near (intervention* or therap* or distract*)

#19  (((audiovisual or (audio next visual) or visual*) and distract*) or movie* or television* or tv or game* or toy* or (virtual next reality) or (tactile next stimulat*))

#20  (multisensory or multi-sensory) next stimulation

#21  MeSH descriptor Therapeutic Touch, this term only

#22  MeSH descriptor Relaxation, this term only

#23  MeSH descriptor Breathing Exercises, this term only

#24  MeSH descriptor Laughter Therapy, this term only

#25  MeSH descriptor Psychotherapy explode all trees

#26  desensiti* or relax* or (therapeutic next touch*) or (breathing next exercise*) or hypnosis or hypnoti* or hypnotherapy or image* or psychotherap*

#27  (autogenic next training) or (auto next suggestion*)

#28  (colour* or color* or music* or play) and (therap* or distract*)

#29  (#17 OR #18 OR #19 OR #20 OR #21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27 OR #28)

#30  MeSH descriptor Child explode all trees

#31  MeSH descriptor Infant explode all trees

#32  MeSH descriptor Adolescent explode all trees

#33  child* or infant* or adolescent* or adolescence

#34  (#30 OR #31 OR #32 OR #33)

#35  (#13 AND #16 AND #29 AND #34)

 

Appendix 4. EMBASE search strategy

1   exp needle/

2   (needle* or inject*).mp.

3   (immuni* or vaccin* or finger prick* or heel prick*).mp.

4   (lumbar puncture* or spinal tap*).mp.

5   (bone adj (aspiration or biops*)).mp.

6   (intravenous or intra-venous or venepuncture* or venous cannulation*).mp.

7   (catheter adj5 insert*).mp.

8   (central line adj5 insert*).mp.

9   (local adj (analges* or anaesthe* or anesthe*)).mp.

10 (arterial adj (puncture or line*)).mp.

11 (artery adj5 puncture).mp.

12 (thoracocentesis or paracentesis).mp.

13 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12

14 pain/

15 ((needle* or immuni* or vaccin* or inject* or procedure* or intervention*) adj5 (pain* or distress* or discomfort or fear* or fright* or anxious or anxiet*)).mp.

16 14 or 15

17 (rehears* or coping or verbal* encourage* or positiv* reinforce* or reward* or token* or self talk* or selftalk* or stop signal* or structured attention).mp.

18 ((cognitive* or behaviour* or behavior*) adj5 (intervention* or therap* or distract*)).mp.

19 (((audiovisual or audio visual or visual*) and distract*) or movie* or television* or tv or game* or toy* or virtual reality or tactile stimulat*).mp.

20 ((multisensory or multi-sensory) adj stimulation).mp.

21 breathing exercise/

22 HYPNOSIS/

23 exp psychotherapy/

24 (desensiti* or relax* or therapeutic touch* or breathing exercise* or hypnosis or hypnoti* or hypnotherapy or image* or psychotherap*).mp.

25 (autogenic training or auto suggestion*).mp.

26 ((colour* or color* or music* or play) and (therap* or distract*)).mp.

27 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26

28 child/

29 infant/

30 adolescent/

31 (child* or infant* or adolescent* or adolescence).mp.

32 28 or 29 or 30 or 31

33 13 and 16 and 27 and 32

key:

mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer

Appendix 5. IBI Web of Knowledge search strategy

# 6 396

#5 AND #4 AND #3 AND #2

Databases=SCI-EXPANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2005-2011

  
 
# 5 >100,000

Topic=(audio visual* OR audiovisual* OR touch* OR humor OR humour OR laugh* OR psychotherapy OR desensit*) OR Topic=(hypnotherap* OR coach* OR inform* OR thought-stop* OR thought stop* OR thought*) OR Topic=(coping* OR cope OR memor* OR train*)

Databases=SCI-EXPANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2005-2011

  
 
# 4 >100,000

Topic=(intervention* OR cognitive* OR cbt OR behavio* OR distract* OR music*) OR Topic=(virtual reality OR rehears* OR coping* OR reinforce* OR hypnosis OR hypnot*) OR Topic=(reward* OR self-talk OR self talk OR relax* OR breath* OR suggest* OR image*)

Databases=SCI-EXPANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2005-2011

  
 
# 3 >100,000

Topic=(intervention* OR cognitive* OR cbt OR behavio* OR distract* OR music*) OR Topic=(virtual reality OR rehears* OR coping* OR reinforce* OR hypnosis OR hypnot*)

Databases=SCI-EXPANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2005-2011

  
 
# 2 4,391

Topic=(child* OR youth* OR teen* OR adolescen* OR infant*) AND Topic=(pain* OR hurt* OR anxiety OR anxious OR distress OR discomfort* OR fear*) AND Topic=(needle* OR inject* OR procedure* OR vaccin* OR lumbar puncture* OR bone marrow OR spinal tap OR intravenous OR venepuncture* OR venipuncture* OR catheter* OR puncture* OR thoracentes* OR paracentes* OR central line*)

Databases=SCI-EXPANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2005-2011

  
 
# 1 >100,000

Topic=(child* OR youth* OR teen* OR adolescen* OR infant*)

Databases=SCI-EXPANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2005-2011

  
 

 

Appendix 6. CINAHL search strategy

 

Query

Limiters/Expanders

Last Run Via

Results

Action

S9

(AB ( intervention* OR cognitive* OR CBT OR behavio* OR distract* OR music* OR TV* OR DVD* OR virtual reality OR rehears* OR coping OR reinforcement* OR reward* OR self-talk OR self talk OR audiovisual OR audio visual OR movie* OR therapeutic touch OR relax* OR breath* OR humor OR humour OR laughter* OR psychotherapy OR desensit* OR hypnosis OR hypnoti* OR hypnotherap* OR image* OR prepar* OR suggest* OR coach* OR inform* OR thought-stop* OR though stop* OR coping OR cope OR memor* OR train* or muscle* OR model* or rehears* )) and (S3 and S4 and S5 and S6)

Expanders - Apply related words
Search modes - Boolean/Phrase

Interface - EBSCOhost
Search Screen - Advanced Search
Database - CINAHL with Full Text

272

Edit S9

S8

(AB ( intervention* OR cognitive* OR CBT OR behavio* OR distract* OR music* OR TV* OR DVD* OR virtual reality OR rehears* OR coping OR reinforcement* OR reward* OR self-talk OR self talk OR audiovisual OR audio visual OR movie* OR therapeutic touch OR relax* OR breath* OR humor OR humour OR laughter* OR psychotherapy OR desensit* OR hypnosis OR hypnoti* OR hypnotherap* OR image* OR prepar* OR suggest* OR coach* OR inform* OR thought-stop* OR though stop* OR coping OR cope OR memor* OR train* or muscle* OR model* or rehears* )) and (S3 and S4 and S5 and S6)

Expanders - Apply related words
Search modes - Boolean/Phrase

Interface - EBSCOhost
Search Screen - Advanced Search
Database - CINAHL with Full Text

Display

Edit S8

S7

AB intervention* OR cognitive* OR CBT OR behavio* OR distract* OR music* OR TV* OR DVD* OR virtual reality OR rehears* OR coping OR reinforcement* OR reward* OR self-talk OR self talk OR audiovisual OR audio visual OR movie* OR therapeutic touch OR relax* OR breath* OR humor OR humour OR laughter* OR psychotherapy OR desensit* OR hypnosis OR hypnoti* OR hypnotherap* OR image* OR prepar* OR suggest* OR coach* OR inform* OR thought-stop* OR though stop* OR coping OR cope OR memor* OR train* or muscle* OR model* or rehears*

Limiters - Published Date from: 20050101-
Expanders - Apply related words
Search modes - Boolean/Phrase

Interface - EBSCOhost
Search Screen - Advanced Search
Database - CINAHL with Full Text

Display

Edit S7

S6

AB intervention* OR cognitive* OR CBT OR behavio* OR distract* OR music* OR TV* OR DVD* OR virtual reality OR rehears* OR coping OR reinforcement* OR reward* OR self-talk OR self talk OR audiovisual OR audio visual OR movie* OR therapeutic touch OR relax* OR breath* OR humor OR humour OR laughter* OR psychotherapy OR desensit* OR hypnosis OR hypnoti* OR hypnotherap* OR image* OR prepar* OR suggest* OR coach* OR inform* OR thought-stop* OR though stop* OR coping OR cope OR memor* OR train* or muscle* OR model* or rehears*

Limiters - Published Date from: 20050101-
Expanders - Apply related words
Search modes - Boolean/Phrase

Interface - EBSCOhost
Search Screen - Advanced Search
Database - CINAHL with Full Text

Display

Edit S6

S5

AB pain* OR hurt* OR anxiety OR anxious OR distress* OR discomfort* OR fear*

Limiters - Published Date from: 20050101-
Expanders - Apply related words
Search modes - Boolean/Phrase

Interface - EBSCOhost
Search Screen - Advanced Search
Database - CINAHL with Full Text

Display

Edit S5

S4

AB child* OR youth* or teen* or adolescen* OR infant*

Limiters - Published Date from: 20050101-
Expanders - Apply related words
Search modes - Boolean/Phrase

Interface - EBSCOhost
Search Screen - Advanced Search
Database - CINAHL with Full Text

Display

Edit S4

S3

AB needle* OR inject* OR vaccin* OR lumbar puncture* OR bone marrow OR spinal tap OR intravenous OR venepuncture* OR venipuncture* OR catheter* OR puncture* OR thoracentes* OR paracentes* OR central line*

Limiters - Published Date from: 20050101-
Expanders - Apply related words
Search modes - Boolean/Phrase

Interface - EBSCOhost
Search Screen - Advanced Search
Database - CINAHL with Full Text

Display

Edit S3

S2

AB needle and AB pain and AB children

Limiters - Published Date from: 20050101-
Expanders - Apply related words
Search modes - Boolean/Phrase

Interface - EBSCOhost
Search Screen - Advanced Search
Database - CINAHL with Full Text

Display

Edit S2

S1

needle and pain and children

Limiters - Published Date from: 20050101-
Expanders - Apply related words
Search modes - Boolean/Phrase

Interface - EBSCOhost
Search Screen - Advanced Search
Database - CINAHL with Full Text

Display

Edit S1

 

 

What's new

DateEventDescription
2 September 2013New citation required and conclusions have changedSince the last version of this review (published in 2006), new relevant studies have provided additional information to change the conclusions.
20 March 2013New search has been performedReview updated. This update differed from the original review by limiting the included studies to true RCTs published in academic journals (i.e. excluded quasi-randomized trials and dissertation studies). As such we excluded seven studies from the 28 included in the original review and added an additional 18 studies from this review update, for a total of 39 RCTs included in the update.

History

Protocol first published: Issue 1, 2005
Review first published: Issue 4, 2006

DateEventDescription
24 September 2010AmendedContact details updated.
13 May 2009AmendedContact details updated.
2 July 2008AmendedConverted to new review format.

Contributions of authors

Lindsay Uman was the lead review author and was involved with review development, study searching, study retrieval, abstract and study review, study selection, data extraction, data entry, statistical analyses, and report writing.

Kathryn Birnie was involved in conducting literature searches, abstract and study review, data extraction, risk of bias coding, report writing, and report editing.

Melanie Noel was involved in conducting literature searches, abstract and study review, data extraction, risk of bias coding, report writing, and report editing.

Jennifer Parker was involved in conducting literature searches, reporting writing, and report editing.

Christine Chambers provided pediatric and pain management expertise, assisted with protocol development, study selection, interpretation of results, and report editing.

Patrick McGrath provided pediatric and pain management expertise, assisted with protocol development, study selection, and report editing.

Stephen Kisely provided expertise in conducting systematic reviews, statistical analyses, protocol development, reporting results, and report editing.

Declarations of interest

None to declare

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • CGS-M Award from the National Science and Engineering Research Council (NSERC) awarded to LS Uman (2004 to 2005), Canada.

  • Graduate Award from the Nova Scotia Health Research Foundation (NSHRF) awarded to LS Uman (2005 to 2006), Canada.

  • Pain in Child Health (PICH) top-up funding awarded to LS Uman (2004 to 2006), Canada.

  • Dalhousie Cochrane Group funding awarded to LS Uman, Canada.

  • Canada Research Chairs (CRCs) awarded to C Chambers and P McGrath, Canada.

Differences between protocol and review

Expanded age range from three to 18 to two to 18 years from the protocol to the original review. This updated review differed from the original review by excluding non-randomized trials and excluding non-published trials (for example, dissertations).

Notes

Not applicable.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Balan 2009

MethodsAllocation: randomized using a random number table
Participants

Needle Procedure: venepuncture for blood collection

Inclusion:

-children aged 5-12 years requiring venepuncture for blood collection (Note: children over 7 enrolled only if provided assent)

Exclusion:

-children with a history of hypersensitivity to local anesthetics of the amide type (lidocaine, prilocaine, mepivicaine, bupivicaine, etidocaine) or to one or more constituents of EMLA

-history of congenital or idiopathic methaemoglobinaemia, glucose-6-phosphatase deficiency or severe hepatic disease

-children with altered sensorium and this found to have hearing impairment on clinical examination

-children whose clinical condition warranted urgent administration of drugs

N: 100

Age: 5-12 years

Gender: F=45, M=55

Diagnosis: heterogeneous. See exclusion criteria

Setting: Inpatient department at hospital, Mumbai

Interventions

1. Music Therapy (n = 50): Indian instrumental classical music (Type of music: Hindustani classical music – instrumental – raaga) ‘Todi’ was played with the walkman for children belonging to the music group.

2. Local Anaesthesia (LA) (n = 50): Similar procedure as the placebo group; however EMLA cream (lidocaine 2.5% and prilocaine 2.5%) and not a placebo cream was used for local application.

3. No Intervention (Placebo) (n = 50): The placebo group was included in the study, as ‘not using anything’ (equivalent to placebo). Placebo cream (2.5g) consisting of 100% petroleum jelly was applied to the local body part with an occlusive dressing for 45 min. Earphones attached to a ‘Walkman’ were applied to the child’s ears for 15 min before the procedure, through the procedure and for 5 minutes thereafter; however, no music was played.

Outcomes

Pain (all ratings at minute 0):

Self-report: VAS (0-10)

Caregiver/Parent: VAS

Nurse/Health Professionals: VAS (by investigator), VAS (by independent observer)

NotesWe used a total N of 100 for this study (instead of 150) because we only assessed 2/3 conditions (music therapy versus placebo group).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"randomized…using random number table" p.470 Par 1
Allocation concealment (selection bias)High riskUse of an open random allocation schedule (e.g. random number table)
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk"Whenever possible this child was also told to indicate his or her score on the VAS." p. 470 Par 2
Selective reporting (reporting bias)High riskOne or more outcomes reported incompletely for inclusion in meta-analysis
Other biasLow riskAppears to be free of other bias that would affect outcomes
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment and researcher provided intervention and outcome assessment

Bellieni 2006

MethodsAllocation: "using random numbers from a computer generated sequence"
Participants

Needle Procedure: venepuncture

Inclusion:

-7-12 years old

-last meal at least 3 h before venepuncture

Exclusion:

-no neurodevelopmental delay

-no frequent venepunctures (more than 1/year)

N: 69

Age: 7-12 years old

Gender: F=36, M=33

Diagnosis: "outpatients"

Setting: no detail provided, Italy

Interventions

1. Cartoon TV Distraction (n = 23): For the TV group, the children were set in front of a TV screen, at a distance of approximately 2.5 m; movies started at least 120 s before venepuncture. The children were invited to watch the cartoon when it started and no other distraction. Mothers were present in the blood sampling room, but were requested to not do anything to distract the children during venepuncture.

2. Mother-Directed Distraction (n = 23): Mothers were asked to actively distract their children during the venepuncture by speaking, caressing, and soothing them.

3. No Distraction Control (n = 23): Mothers were present in the blood sampling room, but were requested to not do anything to distract the children during venepuncture.

Outcomes

1. OUCHER - child self-report

2. OUCHER - parent-report

NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"using a random numbers from a computer generated sequence" p.1015 Par 2
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists (e.g. parenting pain rating…"ignoring the score given by the child" p.1015)
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Bisignano 2006

MethodsAllocation: stratified randomization process was used, randomized according to gender's TAQ scores (high, medium, low) - TAQ-threat appraisals
Participants

Needle Procedure: IV Procedures

Inclusion:

-English-speaking 7-18 year olds scheduled for IV procedures at the paediatric haematology/oncology clinic at a large urban medical centre

-histories included at least two previous IVs

Exclusion:

-none given

N: 30

Age: 6-18 years (Mean = 11.4)

Gender: F=15, M=15

Diagnosis: cancer inpatients and outpatients at a paediatric haematology/oncology clinic. Also, sickle cell anaemia, lymphoma, leukaemia, osteosarcoma, etc

Setting: Haematology/Oncology clinic at large urban medical centre

Interventions1. CD-ROM Intervention (n=14): CD Rom available free of charge from Starlight Starbright to children, families, and health professionals as part of the STARBRIGHT ExplorerSeries (http://www.starlight.org). The CD-ROM was designed to help children learn about the medical procedure. Children in the intervention condition had approximately 20 min to interact with the CD-ROM. Spotlight on IVs is an interactive CD-ROM that consists of four components: education/information, pre-procedural preparation (video modelling), breathing exercises, and distracting imagery. In the education/information section, the CD-ROM allows children to ask questions such as “What is an IV?” and “How does an IV work?” using an animated nurse character named Ima Helpa. In addition, children are educated on IV procedural terms. During pre-procedural preparation, children are given a choice of viewing two videos on IV procedure. The first demonstrates a young girl being given an IV by a nurse, and the second uses a young boy to demonstrate how to get around with an IV attachment. In the breathing exercises section, the children are taught simple breathing exercises by Ima Helpa. Children are instructed to take a deep breath and to let it out slowly. For imagery, children are taught a simple imagery technique focusing on a calming location. This may serve two purposes, distraction and relaxation. In addition to Spotlight on IVs, a second CD-ROM, Spotlight on IV Catheters, developed by the first author, was utilized. This CD-ROM focused on the particular IV procedures used with some of the children (i.e., Broviac, Port-a-cath), because Spotlight on IVs does not provide images of these procedures. Haematology–oncology paediatric patients encounter various types of IVs, including Hickman, Broviac, Port-a-cath, and PICC. Spotlight on IV Catheters contains information and images specific to all three kinds of IVs, whereas Spotlight on IVs only demonstrates PICCs. Like Spotlight on IVs, Spotlight on IV Catheters is colourful and appropriate for children ages 7 to 18. Children in the treatment group viewed both CD-ROMs.
2. Standard Medical Care Condition (n=16): Children received the routine hospital preparation for the IV procedure. This preparation included an explanation of the IV procedure and explanation of the topical anesthetic cream (EMLA) approximately 1 hr prior to the IV procedure.
Outcomes

1. Children's Pain Self-Report (Pain-SR) - aka a "pain thermometer", ranging from 0-100 - immediately after IV

2. Children's Fear Self-Report (Fear-SR) - single item faces scale. Administered 1) after intervention and before IV and 2) after IV (only interested in after IV)

3. VAS (administered by trained RA) - measuring overall anxiety during IV, range 1-5

4. Procedural Behavioral Rating Scale (PBRS) - 3 phases, 1) before 2) during pre-numb swab/anaesthetic 3) during procedure until needle is out (only interested in phase 3)

NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
High riskNo reason provided for missing data and imbalance in missing data across groups
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasHigh riskMultiple potential sources of bias related to study design and other problems
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

Blount 1992

MethodsAllocation: Randomized - no further details
ParticipantsNeedle Procedure: Routine immunization
Inclusion:
-children attending a local county health department
Exclusion:
- none given
N: 60
Age: 3-7 years (M = 5 years, SD = 10 months)
Gender: M = 32, F= 28
Diagnosis: none
Setting: Local county health department
Interventions

1. Distraction + Coping Skills Training + use of a party blower as an age appropriate version of deep breathing (n = 30): Activities the children would engage in prior to the procedures included coloring, playing with toys/puzzles, or interactive reading of a book. Coping skills training involved providing parents with a rationale for the training and instructing them to coach their child to blow a party blower immediately prior to and during the injections. The use of these components was modelled for the parents and children by assistants assuming the roles of nurse, child, and parent. The parent then practised the coaching in a role-play with the assistant using a pretend needle, and was given feedback and praise. Children were allowed to play with the toys and blowers, and were encouraged to watch the training. One role-play was attempted with the child. The total training session took 10-12 minutes.

2. No-Treatment Control (n = 30): Control condition parents were asked to provide demographic information and rate their child's fear and how much they expected to be able to help their child during the medical procedures. Children were asked to provide ratings of their fear using a faces scale. The control subjects waited until called for their immunization, while the treatment subjects completed the demographic questionnaire and underwent the coping skills training prior to completing the other pre-injection inventories.

Outcomes1. Child-Adult Medical Procedure Interaction Scale (CAMPIS)
2. Observational Scale of Behavioral Distress (OSBD)
3. Behavioral Approach-Avoidance and Distress Scale (BAADS)
4. Parent ratings of child fear, pain, and distress using a 10 cm VAS
5. Child self-reports of fear and pain using a 5-faces scale
6. Nurse ratings of child distress
NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely
Other biasHigh riskPotential source of bias related to validity of measurement tool with participant young age
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Caprilli 2007

MethodsAllocation: "children were randomly assigned to one of two groups"
Participants

Needle Procedure: venepuncture

Inclusion:

-only native-born, Italian speaking children

Exclusion:

-significant hearing or visual impairments

-cognitive disorders

-previous experience of hospitalization

N: 108

Age: 4-13

Gender= F=56, M=52

Diagnosis: unclear

Setting: Anna Meyer Pediatric Hospital, Florence, Italy

Interventions

1. Music Distraction (n = 54): Children received live music intervention before, during, and after blood sampling. The same two musicians participated in the entire study. One of the two musicians met the child and the parent in the waiting room. He started playing, singing, and proposing sonorous objects to the child and the parents and invited everybody to join the performance: the musician’s aim was to create a relationship with the child and the parents. The musician then asked whether the child would be happy to have him in the procedure room, and if the child agreed, he went in and continued playing and singing while the procedure was going on. After the procedure was finished, he went back to the waiting room together with the child and the parent, always interacting and playing music with them. The musician stayed with the child approximately 20 minutes.

2. Control (n = 54): Children in this group received standard medical care. The doctor and nurse who performed the procedure were the same for the control and the music groups, and they were instructed to maintain their normal modes of consolation and/or distraction.

Outcomes

Pain:

Self-Report: Wong Baker Faces Scale (higher = more pain)

Distress:

Behavioral report: Amended form of Observation Scale of Behavioral Distress (OBSD-A)

Phase 2=during needle, Phase 3=after needle

NotesOnly used outcomes for phase 2 in analyses.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely
Other biasHigh riskHad a potential source of bias related to the specific study design (e.g. timing of parent ratings)
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Cassidy 2002

MethodsAllocation: Randomized using a standard randomization table for each cluster of 10 subjects
ParticipantsNeedle Procedure: DPTP immunization
Inclusion:
- 5 years old
- due to receive standard DPTP preschool immunization
- in good health
- developmentally normal (i.e. the absence of developmental delays, in the expert opinion of the attending paediatrician)
- subject's parent/guardian agreement to participate after initial recruitment contact
Exclusion:
- previously immunized with the preschool DPTP vaccine
- previously hospitalized
- the presence of any acute or chronic medical condition
N: 62
Age: all 5 years old
Gender: M = 28, F = 34
Diagnosis: none
Setting: two urban paediatric practices in Halifax, Nova Scotia, Canada.
Interventions

1. Audio-Visual (AV) Distraction Using an Age-Appropriate TV Musical Cartoon (n = 29): For both the distraction and control group, once in the examining room, the child sat on the examining table and faced a 30 x 36 cm TV screen at eye level approximately 2 m away from the examining table. A video recorder was placed above the television, and the research stood behind the AV equipment to operate the video camera. The research greeted the child and asked him/her to watch the TV screen. The parent was asked to stand to the child’s right side, hold his/her right hand, and not to talk during the intervention. For the distraction group, the cartoon was turned on by the researcher after the clinician approached the child from the left side and immediately before the immunization. The section of cartoon chosen was started at a point in a musical number to be optimally engaging.

2. Blank TV Screen Control (n = 33): Same initial procedure as treatment group; however, in this in this group, the TV was not turned on.

Outcomes1. Parent ratings of child anxiety before procedure on 10 cm VAS (1 = no anxiety, 10 = worst anxiety imaginable)
2. Child self-report of pain immediately after procedure using the Faces Pain Scale (FPS)
3. Blinded experimenter ratings of pain from videotaped procedures using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
4. Blinded experimenter ratings of pain from videotaped procedures using the Child Facial Coding System (CFCS)
5. Two objective distraction scores for "watch TV" (i.e. time spent watching TV screen) and "watch needle" (i.e. time spent watching needle) coded from videotaped procedures by experimenters
NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"subjects were randomly assigned…using a standard randomization table" p.110 Par 2
Allocation concealment (selection bias)Low riskUse of an open random allocation schedule (e.g., random number table)
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo reasons for missing data provided and unclear  of potential impact on outcomes
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasHigh riskMultiple potential sources of bias related to study design and other problems (e.g., non-neutral control stimulus)
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel  were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

Cavender 2004

MethodsAllocation: Randomized - using a table of random numbers
ParticipantsNeedle Procedure: venepuncture or IV insertion
Inclusion:
- English-speaking between 4 and 11 years old
- had medical order written for venepuncture or IV insertion
Exclusion:
- children with chronic illness
- children presenting with possible child abuse
N: 43
Age: 4-11 years old (M = 7.88 years, SD = 1.74 years)
Gender: M = 19, F = 24
Diagnosis: 11 = Surgical, 7 = Trauma, 9 = Vomiting, 4 = Other
Setting: Emergency department of a private, 322 - bed, paediatric
medical centre in the Southwestern United States
Interventions

1. Parental Positioning + Distraction (n = 20): In addition to receiving standard care, the parents in this group were taught by a child life specialist, using a standard script, how to position and distract their child during venepuncture. The two types of positioning included side-sitting (parent sat in chair next to exam table and child sat sideways on his/her lap) or chest-to-chest sitting (parent sat in chair next to exam table and child sat on his/her lap chest-to-chest). The parent and patient decided which of the two types of positioning to use based on age and size of the patient and parent. In addition, all patients in the experimental group chose from one of three distraction items to use during the procedure. These included the Illusion Kaleidoscope (glitter suspended in a fluid-filled tube passes before the lens when held to the eye and requires no manipulation to change images), I Spy: Super Challenger book (child asked to find items hidden on the page among multiple graphic designs) or Thomas the Tank Engine's Big Lift-and-Look Book (child encouraged to open flaps to find hidden items). Following parental positioning, parents were instructed to engage their child with the distraction by asking the child repeated questions about the activity and reminding them to concentrate on what they were saying and what they were asking the child (e.g., "Look at the colors in the Kaleidoscope. Tell me what you see").

2. Standard Care Comparison/Control (n = 23): Children received the institution’s standard care for venepuncture, including a full explanation of the procedure and parental presence for support.

Outcomes1. Child self-reported pain during procedure using the FACES scale
2. Child self-reported fear during the procedure using the Glasses Fear Scale
3. Parent and Child Life Specialist ratings of child fear during the preprocedural and post-procedural time periods using the Glasses Fear Scale
4. Child Life Specialist ratings of child distress using the Procedural Behavior Checklist (PBCL)
Notes'Positioning’ (e.g., positioning the parent and/or child in such a way as to increase proximity and comfort during the procedure) was not included as one of the interventions explicitly assessed in this review because it was conceptualized as more of a physical intervention than a psychological one. However, we still included this study in this review under a separate intervention category called 'Parent Positioning + Child Distraction', because the positioning was incorporated into the distraction and the distraction was a fundamental component of the intervention.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"randomly assigned…by a table of random numbers" p.36 Par 2
Allocation concealment (selection bias)High riskUse of an open random allocation schedule (e.g. random number table)
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists (e.g. reliability of fear scale)
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel  were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Chen 1999

MethodsAllocation: Randomized - no further details
ParticipantsNeedle Procedure: three consecutive lumbar punctures (LPs; baseline, post-intervention, and follow-up)
Inclusion:
- diagnosis of Acute Lymphoblastic Leukemia (ALL)
- 3-18 years old
- English or Spanish speaking
Exclusion
- none given
N: 50
Age: 3-18 years (M = 7.3 years, SD = 3.7 years)
Gender: M = 67%, F = 33%
Diagnosis: Acute Lymphoblastic Leukaemia (ALL)
Setting: outpatient Children's Center for Cancer and Blood Diseases at the Children's Hospital Los Angeles
Interventions

1. Brief Alteration of Memory Intervention (n = 25): Treatment was conducted at two time points: immediately following the first LP and before the second LP. Parents were allowed to be present but did not actively participate. Children's memories of the most recent LP were elicited through a memory interview that tested for biases in recall of threatening details, anxiety, and pain. In conducting the intervention, the therapist encouraged children to (a) reevaluate their reactions to the last LP through enhancing their beliefs about the efficacy of their own coping strategies (e.g., reminding them how asking the physician assistant questions helped them), (b) realistically appraise their responses to the LP (e.g., assessing the extent to which they cried, screamed, or protested), and (c) increase the accuracy of their subjective memory. The therapist and child discussed specific differences between the child's memories and observed behaviours or the child's previous self-report. Children were not taught coping skills but were encouraged to remember successful coping attempts that they naturally had made. To remind them about the intervention techniques during subsequent procedures, children were offered a fluorescent card that contained a cartoon drawing of a child thinking about his or her LP experience. Children wrote down memories discussed during the intervention on the card and then took the card into the procedure room. This card was intended to trigger thinking about the intervention in the absence of the therapist (during future LPs).

2. Attentional Control (n = 25): Children spent the same amount of time with the therapist as did the treatment group, both after the first and second LP, but were engaged in non-procedure related activities (e.g., drawing). Children in both groups were offered support and encouragement by the nurse and physician assistant during LPs and received preparation from the child life staff, including information and demonstration with dolls. However, children in the attention control group did not have a card to take with them during the LPs.

Outcomes1. Child self-reports of anxiety and pain on 10 cm vertical VAS
2. Parent ratings of child anxiety and pain using 10cm vertical VAS
3. Physician assistant performing the LP ratings of child's procedural distress on the same VAS (physical assistants not blind to treatment condition)
4. Pain and anxiety questions administered to all children; however, they were not analysed if the child was too young to understand
5. 35-item Memory interview
6. Procedure Behavior Check List (PBCL) coded by trained unblinded observers
7. Child systolic and diastolic blood pressure ratings
8. Child heart rate
9. Child salivary cortisol
NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskReasons for missing data unlikely to be related to true outcome
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely (i.e. number of participants per group)
Other biasHigh riskMultiple potential sources of bias related to study design and other problems (e.g. potential impact of group setting)
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Eland 1981

MethodsAllocation: Randomized - no further details
ParticipantsNeedle Procedure: intramuscular injection
Inclusion:
- children scheduled for pre-kindergarten physical examinations
Exclusion:
- none given
N: 20
Age: 4.9-5.9 years
Gender: M = 20, F = 20
Diagnosis: none
Setting: private paediatrician's office in a Midwestern city with a population of 60,000
Interventions

1. Frigiderm Coolant with Cognitive Information (n = 10)
2. Frigiderm Coolant with No Cognitive Information (n = 10)
3. Control Aerosol Spray with Cognitive Information (n = 10)
4. Control Aerosol Spray with No Cognitive Information (n = 10)

Frigiderm Coolant (treatment condition): Altered the transmission of pain messages from the skin surface by spraying a skin coolant on the injection site immediately prior to the injection.

Cognitive Information (treatment condition): Attempted to alter the processing and interpretation of the pain stimulus by the use of positive suggestion. These children were told by the nurse immediately prior to the administration of the injection, “I’m going to spray something on your leg before your shot that will not hurt, will make your leg feel cool, and the spray will make this shot hurt less than other shots you’ve had”.

Aerosol Spray (control condition): Aerosol air was sprayed on the child’s leg immediately prior to the injection.

No Cognitive Information (control condition): These children were told by the nurse immediately prior to the administration of the injection, “I’m going to spray something on your leg before the shot”.

Outcomes

1. Child self-reports of pain using an adaptation of the tool used by Loebach 1979 and Shroeder 1979 comprised of eight 1 1/2 inch color squares placed across the bottom of a white felt board representing different events related to varying levels of pain. To compare the evaluation of pain according to the two levels of each treatment, intervals on the colour scale were assigned numerical ratings. The most painful hurt was rated as a "3", moderate pain was weighted a "2", mild pain a "1", and no pain a "0".

2. Parent and nurse ratings of child anxiety. Parents and nurses were asked to rate the child's anxiety about injections in one of three arbitrary categories: not anxious (scored as a "1"), somewhat anxious (scored as a "2"), or very anxious (scored as a "3").

NotesWe used a total N of 20 for this study (instead of 40) because we only assessed 2/4 conditions (Control Aerosol Spray with Cognitive Information versus Control Aerosol Spray with No Cognitive Information). Also, in this study the description of "Cognitive Information" was more in line with the definition of "Suggestion" as an intervention technique, so it was classified as "Suggestion" rather than "Preparation/Information" in the Results and Analyses.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasHigh riskPotential source of bias related to outcome measurement (e.g. modified measure with "limited reliability" p.370 Par 4)
Blinding of participants and personnel (performance bias)
All outcomes
High riskPersonnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskUnclear if participant blinding, but judged not likely to influence outcome measurement

Fanurik 2000

MethodsAllocation: Randomized - children were assigned to one of four stratified age groups (2-4 years, 5-8 years, 9-12 years, 13-16 years) and then randomized to the treatment or control group - no further details
ParticipantsNeedle Procedure: IV insertion
Inclusion:
- 2-16 years
- generally healthy
- would have EMLA applied for at least 60 min prior to their IV insertion
Exclusion:
- children with chart-documented, parent-reported, or suspected developmental delay or cognitive impairment
N: 160
Age: 2-16 years
Gender: not reported
Diagnosis: none (but undergoing elective outpatient gastrointestinal endoscopy)
Setting: paediatric outpatients in the Gastroenterology Division of the Arkansas Children's Hospital
Interventions

1. Age-Appropriate Distraction (n = 80): Bubbles and musical sound story books were used with the two youngest age groups (2-4, 5-8 years). Sound story books and headsets with a choice of a selection of music were used for children in the 9-12-year old group, depending on their preferences as well as staff assessment of attention span and maturity. Children 13 years and older listened to their choice of selection of music through headsets. Distraction materials were provided to the children while they were waiting to be called to the endoscopy suite, and when they arrived in the suite, nurses immediately engaged them with the distraction materials. Parents were informed that although the nurses would be distracting their children, they could stand close and touch their children. Nurses had been instructed in the use of distraction techniques by a paediatric psychologist.

2. Typical Intervention Control (n = 80): Healthcare personnel interacted in their usual manner with the children but did not attempt to distract them from the procedure. Parents and children were asked to use whatever coping strategies whey would typically employ in this situation. An age-appropriate book was placed on the stretcher in clear view of the parents and children before the family entered the treatment room (although no specific instructions were given about using the book).

Outcomes1. Child self-reports of pain and anxiety using 100 mm VASs obtained for children 5 years of older after IV was taped in place and prior to administration of medication for sedation
2. Three ratings of behavioral distress (pre-procedure, procedure, post-procedure) were recorded on a 6-point numerical scale (0 = not at all distressed, 5 = extremely distressed) by one of the GI specialty nurses (not involved in the medical procedure or intervention), or a research assistant (nurses and research assistants were not blind to experimental group)
3. Parental predictions of child anxiety during IV insertions using 100 mm VAS
4. Behaviours of the children and parents in the comparison group were recorded by observers in a brief narrative form (coded as 'distraction' or 'non-distraction' strategies)
NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
High riskImbalance in numbers for missing data across intervention groups
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Fowler-Kerry 1987

MethodsAllocation: Randomized - randomly assigned with the restriction that there be equal numbers of boys and girls in each group- no further details
ParticipantsNeedle Procedure: immunization
Inclusion:
- healthy children 4.5-7 years old
Exclusion:
- none given
N: 160
Age: 4.6-6.2 years (M = 5.5 years)
Gender: M = 100, F = 100
Diagnosis: none
Setting: patients attending one of three community health clinics located near a large metropolitan area
Interventions

1. Distraction (n = 40): Subjects had headphones placed over their ears and a piece of music suitable for children was played immediately prior to and during the injection.

2. Suggestion (n = 40): Subjects were told that the experimenter was going to help them when they had their injection. The headphones were placed over their ears but no music was played.

3. Distraction + Suggestion (n = 40): Subjects received both the music and the suggestion of assistance with pain relief.

4. Control condition with headphones (n = 40): Subjects did not receive distraction or suggestions, but did wear headphones.

5. Control condition without headphones (n = 40): Subjects did not receive distraction or suggestions, and did not wear headphones.

*Note: The study results combined the two control conditions into one overall control group of 80 participants.

OutcomesChild self-report of pain using four-point VAS (0 = no pain, 3 = most pain possible) where subjects were shown a card with four equal sized blocks representing the range of pain of the scale and asked to point to the block which represented their pain.
NotesWe used a total N of 160 for this study (instead of 200) because we only assessed 4/5 conditions (Distraction versus Combined 2 Control Conditions and Suggestion versus Combined 2 Control Conditions).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists (e.g., "failure of suggestion may be attributed to an ineffective suggestion statement" p.174 Par 2)
Blinding of participants and personnel (performance bias)
All outcomes
High riskAlthough authors report blinding of participants and personnel, the nature of psychological intervention precludes this
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment (see previous comment)

Gold 2006

MethodsAllocation: stratified according to age (7-9, 10-12), then randomized to condition
Participants

Needle Procedure: paediatric IV placement

Inclusion:

-awaiting outpatient MRI or CT scans required IV placement

Exclusion:

-children with known or reported cognitive disabilities

-taking pain medication

-children who did not pass the cognitive and physical screening

N: 20

Age: 8-12 years

Gender: F=8, M=12

Diagnosis: heterogeneous, 12/20 had "medical conditions"

Setting: Children's hospital, Department of Radiology

Interventions

1. Virtual Reality (VR) Distraction (n= 10): This intervention involved a VR distraction presented via a head-mounted display. The virtual environment (VE), Street Luge, by Fifth Dimension Technologies (5DT), featured a fast-moving reality-based world in which the player races downhill lying on top of a big skateboard. The VE was presented via the 5DT HMD 800, a high-performance professional HMD that provides active matrix LCDs with full SVGA (800 _ 600 _ 3 [rgb]) pixel resolution. An InterSense Inertia Cube2 with a 3-degrees-of-freedom (DOF) tracker was attached. The player navigated through the VE with a Logitech rumble pad that provided tactile feedback and music via headphones, thus supplying a multi-sensory immersive experience. The HMD was connected to a Dell laptop (<www.dell.com>), Inspiron 8500 with 2.6-GHz processing speed and 1 GB of RAM, operating on Microsoft Windows XP and a NVIDIA GeForce4 4200 Go video card. Children in this treatment group received the VR intervention plus standard care. They began interacting with the VE 5 minutes prior to the IV placement, continued play throughout, and interacted with the VR for 5 subsequent minutes.

2. Standard Care (n= 10): Topical anesthesia spray prior to IV placement, with no distraction. Children in this control group received only standard care and no VR. They were given an opportunity to play with the VR for

3 min following the completion of their IV placement.

Outcomes

Pain and Distress measures:

1. Faces Pain Scale-Revised (FPS-R) to assess affective pain (worry about both related to pain

2. Wong Baker FACES Pain Rating scale to assess affective pain (worry about both related to pain

3. Visual Analog Scales (VASs) to assess pre-existing pain, IV pain intensity, past IV pain intensity, and anticipatory anxiety about the current procedure

NotesOther outcome measures not specifically related to procedural pain and distress were also used (e.g., measures for anxiety sensitivity, sickness, engagement, etc) but are not reported here because they were not relevant to this review. Similarly, VAS anticipatory anxiety was also assessed but was not included in our analyses because we focused on anxiety during the procedure.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely (i.e. nurse and parent report)
Other biasHigh riskSmall sample size potential source of bias affecting outcomes
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

Gonzalez 1993

MethodsAllocation: Randomized - using a block randomization procedure that took age into account - no further details
ParticipantsNeedle Procedure: routine injections
Inclusion:
- none given
Exclusion:
- none given
N: 28
Age: 3-7 years
Gender: M = 21, F = 21
Diagnosis: none
Setting: recruited from the general pediatric primary care clinic at a large, urban public hospital
Interventions

1. Maternal Reassurance (n = 14): Mothers received: (a) oral instructions on how to reassure their child verbally during the medical procedure, (b) listened to an audio cassette of a parent demonstrating the type of verbal reassurances that should be used, and (c) practised their reassuring verbal strategies with the help of an assistant. Mothers were also instructed to engage in reassurance throughout the recording period.

2. Distraction (n = 14). Mothers received: (a) oral instructions on how to distract their child verbally during the medical procedure, (b) listened to an audio cassette of a parent demonstrating the type of distractions that should be used, and (c) practiced their distracting verbal strategies with the help of an assistant. Mothers were also instructed to engage in distraction throughout the recording period.

For both the Maternal Reassurance and Distraction groups, a large sign with examples of appropriate vocalizations was posted approximately 2 metres from the parents to help cue them during the medical procedure. Throughout the procedure a research assistant pointed to the sign each time the mother stopped engaging in the appropriate vocalization for more than 10 seconds. The two research assistants who were present throughout the procedure did not interact with the mother or child in any other manner.

3. Control (n = 14): Mothers received a short lecture on transportation to the hospital, listened to an audio cassette that provided additional information about transportation, and discussed transportation issues with a research assistant.

Outcomes1. Research assistant ratings of child distress using the Modified Frankl Behavior Rating Scale
2. Child self-report of pain during the procedure using the Oucher Pain Rating Scale
3. Observers blind to group assignment ratings of child distress during the procedure, using the Observational Scale of Behavioral Distress-Revised (OSBD-R) coded from videotapes of the injection for the injection and post-injection time periods
4. Observers blind to group assignment ratings of parental adherence to the experimental manipulation using the 'nonprocedure-related talk' and 'reassuring comment' codes of the Child-Adult Medical Procedure Interaction Scale (CAMPIS)
NotesWe used a total N of 28 for this study (instead of 42) because we only assessed 2/3 conditions (Distraction versus Control). This is because there is already considerable existing research to suggest that reassurance is a distress-promoting strategy, and was therefore not included as one of the interventions assessed in this review.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk (e.g. research assistant ratings)

Goodenough 1997

MethodsAllocation: Randomized - stratified by age - no further details
ParticipantsNeedle Procedure: venepuncture
Inclusion:
- children aged 3-17 years consecutively scheduled to undergo venepuncture
Exclusion:
- children with a major mental handicap
N: 78
Age: 3.5-17.7 years
Gender: M = 73, F = 44
Diagnosis: none (although 36 children were undergoing venipuncture as part of ongoing investigation for chronic illness)
Setting: Sydney Children's Hospital
Interventions

1. Placebo Cream + Suggestion (n = 39): The placebo cream involved a disinfectant handwash which was odourless thick white foam with no anesthetic properties. The suggestion involved having the nurse say to the child “We are trying out a new special cream. I am going to put some cream on your arm that might make it (the needle) hurt less”. In this condition, the cream was dispensed from a brightly wrapped container as a means of visually reinforcing the child’s expectancy that the cream might help.

2. Placebo Cream Alone (n = 39): Only application of the placebo cream described above with no suggestion. In this condition, the nurse said to the child “I am going to put some cream on your arm” and the cream was dispensed from a plain while wrapped container.

For both of the above conditions using the placebo cream, the cream was applied to the arm with cotton wool, rubbed into the skin, and the excess was removed using cotton wool.

3. No Cream Control (n = 39): No cream was applied and the nurse did not say anything beyond standard procedural instruction.

Outcomes1. Child self-report of pain using the Faces Pain Scale (FPS)
2. Child self-report of anxiety using the Children's Anxiety and Pain Scale (CAPS)
3. Child self-report of whether the cream had helped to reduce the needle-pain
4. Observer ratings of child behavioral reaction to pain during the needle
NotesWe used a total N of 78 for this study (instead of 117) because we only assessed 2/3 conditions (Placebo Cream + Suggestion versus Placebo Cream Alone).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskReasons for missing data unlikely to be related to true outcome
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasLow riskAppears to be free of other bias that would affect outcomes
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk

Gupta 2006

MethodsAllocation: prospective randomized study, randomized with a computer-generated table of random numbers
Participants

Needle Procedure: venepuncture "venous cannulation"

Inclusion:

-children aged 6-12 years, ASA physical status I-II, undergoing venous routine surgical procedures

Exclusion:

-children with delayed milestones, cardiac or neurobiological impairment, or failure to cannulate on first attempt

N: 75

Age: 6-12 years

Gender: F=31, M=44

Diagnosis: paediatric patients, ASA physical status I–II, undergoing elective surgery

Setting: not specified (just states that procedure was done in "preoperative area")

Interventions

1. Distraction group (n=25): Patients were given a rubber ball (which produces a squeaky sound on being compressed) in the palm of their hand which was not to be cannulated. The patients were asked to alternately compress and release the ball.

2. Balloon group (n=25): Patients were asked to inflate a balloon at least for 20 seconds before initiation of the venipuncture. The cannula insertion was performed during the act of forceful expiration. A small plastic hollow pipe was attached to the end of the balloon from where it is inflated and fixed to make the assembly easier to hold with one hand, thus making the act of inflation easier. According to study authors, balloon inflation may have a combined effect of distraction and increasing intrathoracic pressure making the veins more prominent and easier to cannulate.

3. Control group (n=25): Patients did not press a rubber ball nor were they asked to inflate a balloon.

Outcomes

Pain:

Self-report: VAS (10cm). On back of Pain Face Scale. Children placed sliding marker between extreme anchors/faces. Administered during venepuncture.

NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"consecutive pediatric patients were randomized with a computer generated table of random numbers" p.1372 Par 3
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)High riskOne or more outcomes reported incompletely for inclusion in meta-analysis
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

Harrison 1991

MethodsAllocation: Randomized - no further details
ParticipantsNeedle Procedure: venous blood sampling
Inclusion:
- 6-12 year olds reporting to four hospital laboratories in Kuwait
Exclusion:
- none given
N: 100
Age: 6-12 years
Gender: M = 51, F = 49
Diagnosis: none
Setting: four hospital laboratories in Kuwait
Interventions

1. Preparation (n = 50): Children in this group were read a preparation story accompanied by pictures, and were encouraged to ask questions. The story offered a simple description of the venous blood sampling procedure, why it is carried out, and what happens to the blood after it has been collected. It emphasized that the procedure creates a brief period of pain, and that the pain is noticeable but not unbearable. The story also stressed that venepuncture is less painful if a child relaxes his arm and cooperates with the technician. In order to increase the likelihood of children modeling the behaviour of the child featured in the story, sex- and age-appropriate models of average appearance were used, and local children, parents, and hospital settings were photographed.

2. No Preparation control (n = 50): No specific description of this group was mentioned in the study. However, it was noted that initial observations revealed that laboratory technicians generally made no attempt to prepare children for venepuncture or to talk them through the procedure. If children protested and struggled, their strategy was to physically restrain the child and complete the procedure. Often, parents were recruited to help.

Outcomes

1. Child self-report of pain using 6-point histogram VAS

2. Parent observer-report of pain and fear using 0-5 scale
2. Radial pulse rates of children before and after the procedure
3. Parent responses to questions related to the procedure

NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient reporting of exclusions to permit judgment of "low" or "high" risk (e.g. some parent-report missing)
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasHigh riskHad a potential source of bias related to the specific study design (e.g. potential impact of group setting)
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Huet 2011

MethodsAllocation: Randomized - randomly assigned by lottery
Participants

Needle Procedure: local dental anaesthetic using "standard metal syringe without electronic assistance after applying a topical anesthetic for 1 min to the area where local anesthetic would be injected"

Inclusion:

Exclusion:

N: 29

Age: 5-12 years old (Median = 9 for control group and 8 for intervention group)

Gender: M = 16, F = 13

Diagnosis: none

Setting: Department of Pediatric Dentistry at Rennes University Hospital

Interventions

1. Hypnosis Intervention (n = 14, + 1 excluded from analyses): Hypnosis was performed following the usual three-step Ericksonian procedure. Hypnotic induction began once the subject was seated in the dentist’s chair. Speaking slowly in a monotone voice, the hypnotherapist made the child focus on her (hypnotherapist) voice and on images to establish a “hypnotic relation”, first taking into account items in the room and then using suggestions and stories. The suggestions or stories used during the induction were linked with things the child was interested in and were chosen according to the initial interview. The child could express any discomfort using a predefined code. All external interventions (e.g., examination with the mirror, placement of towels, injection) were carried out with agreement of the hypnotherapist, who incorporated these interventions in her explanations to the child. A hypnotic trance was considered to have been achieved when the hypnotherapist noted muscular relaxation, regular breathing, and immobility (cataleptic state). The dental anesthesia and treatments were then performed. The hypnotherapist continued speaking to the child to maintain the state of trance. At the end of the treatment session, the hypnotherapist gradually “awoke” the child by speaking a little bit louder and using the items in the room to help the child come back to the initial conscious state. The hypnosis was performed by a single trained operator.

2. No-Hypnosis Control (n = 15): The same general procedure as described above was also used for all the children in this group, except for the hypnosis.

Outcomes

1. Child self-report of pain: Visual Analogue Scale (0-10)

2. Modified Objective Pain Score (MOPS) (0-10 score)

3. Modified Yale preoperative anxiety scale (mYPAS)

NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"randomly assigned by lottery" (p.426)
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data minimal and unlikely to be related to true outcome
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely
Other biasHigh riskMultiple potential sources of bias related to study design and other problems
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Inal 2012

MethodsAllocation: computer-generated table of random numbers into 2 approx equal groups
Participants

Needle Procedure: blood draw (venepuncture) x1

Inclusion:

- 6-12 year old patients who required blood tests

Exclusion:

-neurodevelopmentally delayed

-verbal difficulties

-hearing or visual impairments

-have taken an analgesic within the last 6hrs

-had a history of syncope due to blood draws

N: 123

Age: 6-12 years

Gender: F=61, M=62

Diagnosis: unclear; "non-chronic" illness status (n=49 control; n=53 experimental), "chronic" illness (n=13 control, n=8 experimental) e.g., diabetes, CF, thalassaemia, coeliac

Setting: paediatric clinic, Istanbul, Turkey

Interventions

1. Distraction group (n = 61): Children looked through 5 x 8 cm “Flippits (R)” distraction cards which consisted of various pictures and shapes. The same nurse asked the child questions about the cards during the blood draw procedure that child only answer if he/she examined the cards carefully. The blood-drawing procedure started when the child began looking at the distraction cards carefully. Questions were asked about the cards until the end of the procedure (e.g., “how many spots do the ladybugs have in total?”).

2. Control group (n = 62): Children received no intervention.

Outcomes

Pain:

Child self-report: FPS-R

Caregiver/Parent-Report: FPS-R

Nurse report: FPS-R

Anxiety:

Caregiver/Parent Report: Anxiety set of children's Anxiety and Pain Scales (CAPS) - higher is more anxiety

Nurse Report: Anxiety set of Children's Anxiety and Pain Scales (CAPS)

NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"randomized with a computer-generated table of random numbers" p.212 Par 6
Allocation concealment (selection bias)High riskUse of an open random allocation schedule (e.g., random number table)
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Jeffs 2007

MethodsAllocation: 'randomly assigned to groups' 'using computer generated random numbers table'
Participants

Needle Procedure: Phase II of allergy testing involving injection

Inclusion: early and middle phase adolescents aged 11-17 years

-environmental or food allergen testing

-parental presence

-ability to read and write English

Exclusion:

-bee venom allergy testing

-cognitive and developmental disability (determined by presence of individual educational plan or accommodation that parents identified as related to cognitive delay)

N: 27

Age: 11-17

Gender: F=15, M=17

Diagnosis: not specified explicitly but practice was for allergy, asthma, and immunology patients

Setting: outpatient allergy, asthma, and immunology medical practice within large medical centre

Interventions

1. Self Selected Distraction (n = 9): This group made one selection from an investigator-developed collection of music CDs, including alternative, hip-hop, pop, pop country, and rock music. Popular teen books on cassette and videotapes, including movies, music videos, sports programs, and cartoons, were also available. Several adolescents who were not study participants assisted in the selection of the media.

2. Investigator Selected Distraction (n = 10): This group watched a nursing recruitment videotape targeting an adolescent audience that showed interviews with nurses, identified various nursing roles, and explained the work performed by nurses.

Both distraction groups listened to the media through headphones. All media and equipment were new and provided by the researcher. Distraction was implemented in the intervention groups just prior to and continuously during the actual allergy testing procedure. The physicians’ office nurses, who conducted the allergy testing, were directed to avoid interrupting the distraction.

3. Usual Care Control (n= 8): The UC group received the typical care provided by the physicians’ office nurses who performed the allergy skin testing without any scripting or prompting. Usual care consisted of the typical communication between the office nurse and adolescent about non-allergy testing topics, such as favourite school subjects and sports, as well as allergy testing information. The UC group received no experimental intervention. Allergy testing materials were kept within view of the adolescent; no attempt was made to conceal testing materials.

Outcomes

Self-Report Pain:

Adolescent Pediatric Pain Tool (used pain rating for data extraction)

Wong Baker FACES Scale (0-10)

NotesPhase I allergy testing was used to determine the presence of non-reactive allergens. Distraction was resumed during Phase 2 testing, therefore only Phase II testing was used in the analyses for this review. Phase 1 involved an N of 32 while Phase 2 involved and N of 27; therefore, the total N reported for this study is 27. Also, the two distraction conditions were pooled together to create one overall distraction condition.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskp.175 Par #2 participants randomly assigned "using a computer-generated random numbers table"
Allocation concealment (selection bias)Unclear riskUnclear if all appropriate safeguards taken with assignment envelopes (i.e., sequentially numbered or opaque)
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data for phase included in current review
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasHigh riskMultiple potential sources of bias related to study design and other problems (e.g., low statistical power)
Blinding of participants and personnel (performance bias)
All outcomes
High riskp.172 Par #7 "unblinded experimental design"
Blinding of outcome assessment (detection bias)
All outcomes
High riskp.172 Par #7 "unblinded experimental design" and no blinding of self-report of outcome assessment

Katz 1987

MethodsAllocation: Randomized - stratified by sex - no further details
ParticipantsNeedle Procedure: bone marrow aspiration (BMA) (approximately 50% of the children also underwent a lumbar puncture immediately following their BMA)
Inclusion:
- baseline self-reported pain score > 50 (possible range: zero to 100)
- baseline self-reported fear score > 4 (possible range: 1 to 7)
- Procedural Behavior Rating Scale-revised score > 4 (possible range: zero to 33)
- nurse rating of child anxiety > 3 (possible range: one to five)
Exclusion:
- none given
N: 36
Age: 6-11 years old (M = 8.3 years, SD = 1.68 years)
Gender: M = 24, F = 12
Diagnosis: Acute lymphoblastic leukaemia (ALL)
Setting: Hematology-Oncology clinic at the Children's Hospital of Los Angeles
Interventions

1. Hypnosis (n = 18): Comprised training in hypnosis and self-hypnosis by one of two psychologists experienced in psychological aspects of oncology and hypnosis. Major components of this intervention included the development of rapport, direct discussions about the child’s medical history and treatment needs, a hypnotic induction utilizing eye fixation with or without eye closure, active imagery tailored to the interests of each individual child, deep muscle relaxation, and suggestions. The specific suggestions incorporated were as follows: imagery to reduce or reframe sensory/pain experiences; distraction and relaxation; pairing positive affect with medical procedures; developing a sense of mastery and control over sensory and affective experience; and post-hypnotic suggestions for practicing and re-entering hypnosis with a cue from their therapist during actual procedures.

2. Play control condition (n = 18): This condition was comprised of non-directed play sessions designed to control for the amount of time and attention the child received from a sympathetic hospital professional (i.e., the psychologists performing the interventions). Subjects in this condition were seen prior to BMAs for the same amount of time as those in the hypnosis condition and by the same psychologists. Elements of the non-directed play condition included development of rapport, non-medical play, and no-medical verbal interactions. No discussions about the child’s illness or treatment were initiated. If the child initiated such conversations, the therapists subtly changed the subject.

Outcomes1. Observer ratings of child distress during three temporal phases using the Procedural Behavior Rating Scale- Revised (PBRS-R)
2. Nurse ratings of child anxiety during the procedure using one to five Likert scale
3. Child self-report of fear during the procedure using the Fear Self-Report measure
4. Child self-report of pain during the procedure using the Pain Self-Report (comprised of a graphic rating scale patterned after a thermometer where 0 = no hurt at all, and 100 = the most hurt possible)
5. Therapist ratings of rapport with patient and child's response to hypnosis on one to five scale (1 = excellent, 5 = poor)
NotesOutcomes were assessed at baseline and intervention with repeated measures on the intervention condition as there were 3 BMAs (i.e., Baseline, Post-Treatment 1, Post-Treatment 2, and Post-Treatment 3). Each subject was seen for two intervention sessions prior to their next BMA and sessions were 30 minutes long. For the purpose of this review, we only used data from the first BMA procedure (i.e., Post-Treatment 1).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasHigh riskPotential source of bias related to timing of outcome measurement (e.g., sometimes after multiple procedures)
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants  were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

Kleiber 2001

MethodsAllocation: Randomized - permutated block randomization used to assure that a balanced number of children with histories of high distress were randomized to the control and experimental groups; randomization conducted according to the procedures outlined by Friedman et al, 1996. Randomization achieved using a table of random numbers (see note)
ParticipantsNeedle Procedure: IV Insertion
Inclusion:
- no neurological or sensory impairment at the IV site
- child able to distinguish between biggest and smallest in order to Oucher pain scale
- parent with legal custody agreed to be with the child during the procedure
- parent able to speak and read English
Exclusion:
- none given
N: 44
Age: 4-7 years
Gender: M = 11, F = 33
Diagnosis: children being treated or evaluated for non-life threatening conditions such as chronic urinary tract infections, urinary incontinence, chronic constipation, growth failure, and reactive airway disease
Setting: large Midwestern tertiary care hospital that serves as the primary specialty referral site for a population of approximately three million people. It is located in a state in which the population is predominantly Caucasian, with other races accounting for 5% of the population
Interventions

1. Parent Coaching + Distraction (n = 22): Parents viewed a 7-minute educational video on distraction that was developed for this study (available from authors upon request). The children remained with their parents during the video, and were encouraged to watch it. The narration tells the viewer why and how distraction should be used with children. The viewer is given suggestions on how to choose the most effective distraction strategy. Three parents model distraction with their preschool aged children and explain why they found distraction to be helpful. Finally, parents are told to involve the child in choosing the distraction and to praise the child at the end of the procedure. The video ends with a written summary of the following key points: (a) Focus your child’s attention away from the medical procedure, (b) use activities that keep your child’s attention (interactive books, blowing bubbles, surprise or novel toys, favourite stories), (c) if you lose your child’s attention, keep trying to get it back, (d) using distraction takes some effort, but it can help you child feel more comfortable, and (e) praise your child at the e4nd of the procedure. After viewing the video, the parents and children were shown a basket of distraction items and were encouraged to pick something to use during the IV insertion.

2. Standard Care Control (n = 22): Standard practice in this setting was for individual practitioners to decide whether or not to apply a topic anesthetic cream (EMLA) at the IV site. Parents were invited to accompany their child to the procedure room and stay during the IV insertion. They received no instruction on what to do during the insertion.

Outcomes1. Parent ratings of child's previous distress during medical procedures using a seven-point scale
2. Child self-report of pain during the IV insertion using the Oucher Scale
3. Parent ratings of child distress using the Perception of Procedures Questionnaire-Revised (PPQ-R)
4. Observer ratings of child distress using the Observer Scale of Behavioral Distress-Revised (OSBD-R)
5. Observer ratings of parent distraction behavior coded from videotapes (each 10-second interval of the procedure coded for the presence/absence of parental distraction)
NotesAlthough it was not stated in the paper, personal communication with the author confirmed that randomization was achieved via a random table of numbers.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskReasons for missing data unlikely to be related to true outcome and balanced across intervention groups
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely
Other biasHigh riskMultiple potential sources of bias related to study design and other problems (e.g., low reliability of parent outcome measure)
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report and parent-report of outcome assessment

Kristjansdottir 2010

MethodsAllocation: table of random numbers
Participants

Needle Procedure: Polio Immunization

Inclusion:

-Icelandic-speaking adolescents scheduled for a ninth grade immunization

Exclusion:

none listed

N: 118

Age: 13-15

Gender: F=55, M=63

Diagnosis: healthy (community sample attending school)

Setting: school, Iceland

Interventions

1. Music Distraction with Headphones (n = 38): Participants were asked to wear headphones to listen to music.

2. Music Distraction without Headphones (n = 41): Participants were not asked to wear headphones to listen to music. Instead, they were asked to listen to music from loudspeakers.

In designing the intervention, therapeutic nursing intervention guidelines on distraction to relieve pain and music therapy were used. In addition, a music therapist was consulted. The intervention protocol was the same for both intervention groups and included the following: (a) explaining the purpose of the music to the adolescents (i.e., to distract and to help them cope during/after the immunization), (b) asking them to concentrate on and ‘disappear into’ the music, and continue to do so for a few minutes (2–3 minutes) before and after the immunization, and (c) creating a sense of control in the adolescents by giving them choice (i.e., selecting a CD and controlling the volume setting). The music for the study was selected based upon results from a pilot study. Using a hypothetical immunization, 6 teens (13–15 years old) were interviewed showing they preferred top ten chart music to relaxing music during the immunization. Acknowledging this, the music used in the study was largely chosen from top 10 charts of the day, with the exception of one relaxing classical CD. In selecting the top ten chart music for the study, advice from a music marketing manager who knew adolescent music preferences, was sought.

3. Standard Care Control (n = 39): The school nurses were encouraged to maintain their normal modes of caring, which was to comfort and guide the adolescents verbally. If the adolescents had any questions or concerns prior to the immunization, or discomfort after the immunization, the school nurses responded to these with care.

Outcomes

Pain:

Self-report: VAS (0-10)

NotesThe data from the two distraction conditions were pooled together to create one overall distraction condition.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"table of random numbers was used to randomize into groups" (p.20 Par 11)
Allocation concealment (selection bias)High riskUse of an open random allocation schedule (e.g., random number table)
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Kuttner 1987

MethodsAllocation: Randomized - no further details
ParticipantsNeedle Procedure: bone marrow aspiration (BMA)
Inclusion
- leukaemia patients who had expressed difficulty in coping with the recurrent BMAs and Lumbar Punctures (LPs) that constituted an essential part of their treatment for cancer
- children 6 years old and younger
Exclusion
- none given
N: 25
Age: 3-6.11 years (larger study compared 3-6 year olds with 7-10 year olds but this paper reports results of younger group only)
Gender: not reported
Diagnosis: Leukaemia
Setting: treatment/surgery room - no further details
Interventions

1. Hypnosis (n = 9): This group received the hypnotic techniques in which the child’s favourite story became the hypnotic vehicle to create a pleasant imaginative involvement that would lead to a different interpretation of the noxious experience. The favourite stories included hypnotic suggestions and reframing. Prior to the medical procedure, the researcher asked the child to tell his/her favourite story, noted the child’s choice of words and emphasis, and then suggested the following plan of action: ‘When we go into the treatment room, how would it be if I tell the story of (insert child’s story title) while the BMA gets done? I wouldn't be surprised if the procedure didn't go much quicker, and by the time the story ends the band-aid will be on and everything will be finished!’ After a 10-20 minute induction and practice session, the researcher accompanied the child and parent into the surgery room where, as soon as the child was lying on the table, a trance was induced and maintained through the procedure. The hypnotic process incorporated active involvement with the child, flexibility, informality, and narrowed/increase absorption of attention. Procedural and sensory information was interwoven into the story-line (e.g., indirect/direct suggestions for comfort, diminishing pain awareness, and increased coping within the story-line). The central characters and heroes/heroines were used as metaphors of courage and feelings of accomplishment. Parents were encouraged to be present and touch or hold the child’s hand; however, the therapist was generally the only adult to talk with the child during the procedure.

2. Distraction (n = 8): Physical objects such as pop-up books, bubbles, and squeezy toys were used during the BMA to shift the child's attention away from the painful procedure and onto these physical objects which contained elements of surprise, play, and opportunities for the child to demonstrate some accomplishment, instead of feeling helpless. For example, the child was encouraged to count interesting objects in the pop-up book, or to blow bubbles, or was challenged to correctly name physical objects.

3. Standard Medical Care Control (n = 8): This group received the standard medical practice, which included providing some information, reassurance, and support.

Outcomes1. Observer ratings of child distress using the Procedure Behavior Rating Scale- Revised (PBRS-R)
2. Observer, physician, nurse, and parents ratings of child's pain and anxiety on five-point rating scales
3. Child self-report of pain and anxiety using an interval picture five-point scale
NotesData necessary for the meta-analysis data pooling (i.e., means and SDs) was reported for the PBRS-R only. Also, because there were two treatment sessions, data was reported for three time points (i.e., baseline, 1st intervention, 2nd intervention). For the analyses in this review, we used data for the 1st intervention only.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient reporting of exclusions to permit judgment of "low" or "high" risk. One or more outcomes of interest are reported incompletely
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely
Other biasHigh riskMultiple potential sources of bias related to study design (e.g., small sample size)
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Liossi 1999

MethodsAllocation: Randomized - table of random numbers (see note)
ParticipantsNeedle Procedure: bone marrow aspirations (BMAs; baseline and intervention)
Inclusion:
- Leukaemia patients between 5 and 15 years old whose medical protocol required at least two BMAs within 2.5 months
Exclusion:
- previous therapy with hypnosis and/or cognitive behavioral (CB) coping
- concurrent treatment during the project with analgesic or psychotropic medication
- a major affective disorder or other psychiatric diagnosis
N: 30
Age: 5-15 years (mean = 8 years, SD = 2.5 years
Gender: M = 17, F = 13
Diagnosis: Leukaemia
Setting: treatment room of clinic - no further details
Interventions

1. Cognitive Behavioural (CB) Intervention (n = 10): This condition involved: (a) relaxation training (two relaxation techniques were taught in the sessions: progressive muscle relations, and an abbreviated form of autogenic relaxation; imagery was not included), (b) breathing exercises (each child was instructed to take a deep breath and to let it out slowly while making a hissing sound), and (c) cognitive restructuring (included training in attention redirection and restructuring self-defeating cognitions; patients were taught to identify helpless or self-defeating thoughts and to interrupt and change these using prepared substitute positive coping thoughts such as “I know I can do it”, or affirmations by focusing attention on neutral or pleasant events /objects or by occupying their attention through mental repetition of affirmations, songs, or prayers).

2. Hypnosis (n = 10): Hypnosis was induced by visual imagery (favorite place, activity, or television program). Two relaxation techniques were taught in sessions: progressive muscle relations and an abbreviated form of autogenic relaxation. Reference to patient well-being, strengths, competence, and comfort were included in the image. Following several minutes of hypnotic involvement, the patient was given analgesic suggestions. Hypnotic suggestions included the following: request for numbness (to make lower back go to sleep for a few minutes), topical anaesthesia (imaging painting numbing medicine on our back), local anaesthesia (imaging injecting and anesthetic into the back), and glove anaesthesia (let hand go numb and let the numb feeling transfer from the hand to back).

3. Standard Treatment Control (n = 10). All patients in this control condition as well as patients in the above two treatment conditions received a standard lidocaine injection.

Outcomes1. Child self-report of pain and pain-related anxiety during one BMA at baseline (time 1) using a six-point faces rating scale (0 = no pain/anxiety, 5 = as much pain/anxiety child can imagine)
2. Nurse ratings of child distress using the Procedure Behavior Checklist (PBCL)
3. Child's hypnotic ability assessed using a Greek translation of the Stanford Hypnotic Clinical Scale for Children (SHCS-Children)
NotesAlthough it was not stated in the paper, personal communication with author confirmed that randomization was achieved via a random table of numbers. Also, the authors note that verbal communication from therapist to child during the procedure comprised brief encouragements (e.g., “You’re doing fine”, “It’s almost over”) and were the same for patients in all the groups. While the authors conceptualized these statements as ‘encouragement’, other research literature would categorize these statements as ‘reassurance’ which has been shown to be a distress-promoting strategy. However, although this could potentially reduce the efficacy of the interventions, since all three conditions received these statements, this would not present as a confound and comparisons between groups are still feasible. Lastly, outcomes were assessed at baseline and post-treatment. For this review, only post-treatment scores were used.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely
Other biasHigh risk"the small number of subjects in this study seriously compromise power and may yield spuriously high correlations" p.112 Par 3
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

Liossi 2003

MethodsAllocation: Randomized - no further details
ParticipantsNeedle Procedure: series of lumbar punctures (LPs) (baselines and using intervention)
Inclusion:
- children with leukaemia or non-Hodgkin's lymphoma
- 6-16 years old
- undergoing regular lumbar punctures over a 4-year period
Exclusion:
-previous hypnosis treatment
-concurrent treatment during the project with analgesic or psychotropic medication
-a major affective disorder or other psychiatric diagnosis
N: 60
Age: 6-16 years (mean = 8.63 years, SD = 2.86 years)
Gender: not reported
Diagnosis: Leukaemia or Non-Hodgkin's Lymphoma
Setting: Hematology/Oncology Department of the Children's Hospital Aglaia Kyriakou, Athens, Greece
Interventions

1. Direct Hypnosis with Standard Medical Treatment (n = 20): Hypnotic suggestions included: request for numbness (to make lower back go to sleep for a few minutes), topical anaesthesia (imaging painting numbing medicine on our back), local anaesthesia (imaging injecting and anaesthetic into the back), glove anaesthesia (let hand go numb and let the numb feeling transfer from the hand to back), and switchbox (imagining using a switch to turn off or modulate incoming pain message nerve signals going from the body to the brain).
2. Indirect Hypnosis with Standard Medical Treatment (n = 20): Using metaphors of a setting sun and Mexican food to imagine details scenes using various senses (e.g., sight, smell, taste), develop cues to experience immediate relaxation, and pictures ways to adapt to discomfort.

Both the direct and indirect hypnosis groups ended with a post-hypnotic suggestion that the hypnotic experience would be repeated during the actual medical procedure with the help of the therapist, and that this would provide comfort during the LP.

3. Attentional Control with Standard Medical Treatment (n = 20): Included elements such as development of rapport, non-medical play, and no-medical verbal interactions (e.g., discussing school, activities, sports, etc). New coping skills were not introduced.

4. Standard Medical Treatment (n = 20): Patients in this group received no therapist contact or treatment intervention, but, like all patients, received standard interventions provided by the hospital staff for pain control during LPs (i.e., medical and nursing staff offered information, support, and reassurance).

Outcomes1. Child self-report of pain and anxiety during three consecutive LPs at baseline and for two consecutive LPs with the intervention, using the six-point Wong and Baker faces rating scale
2. Nurse ratings of child pain during three consecutive LPs at baseline and during two consecutive LPs with the intervention, using the Procedure Behavior Checklist (PBCL)
3. Child self-reports of pain and anxiety during the first, third, and sixth LPs in which self-hypnosis was used
4. Hypnotic ability assessed within two weeks after the last LP using a Greek-translation of the Stanford Hypnotic Scale for Children (SHCS-Children)
NotesThe data from the two hypnosis conditions were pooled together to create one overall hypnosis treatment condition. We used a total N of 60 for this study (instead of 80) because we only assessed 3/4 conditions (Direct + Indirect Hypnosis versus Attentional Control with Standard Medical Treatment). Outcomes were assessed at various time points; however, for this review we only used the 'intervention' time point.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasLow riskAppears to be free of other bias that would affect outcomes
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Liossi 2006

MethodsAllocation: Randomized - table of random numbers
ParticipantsNeedle Procedure: series of lumbar punctures (LPs) (baselines and using intervention)
Inclusion: Greek-speaking patients with leukaemia or non-Hodgkin's lymphoma - between 6 and 16 years
- undergoing regular LPs
Exclusion:
- previous hypnosis treatment
- concurrent treatment during the project with analgesia or psychotropic medication
- major affective disorder or other psychiatric diagnosis
N: 30
Age: 6-16 years
Gender: M = 23, F = 22
Diagnosis: leukaemia or non-Hodgkin's lymphoma
Setting: Hematology/Oncology Department of the Children's Hospital Aglaia Kyriakou, Athens, Greece
Interventions

1. EMLA + Hypnosis (n = 15): The hypnotic induction procedure was adapted according to the child’s age, interests, and cognitive and social development. References to patient well-being, strengths, competence, and comfort were also included in the inductions. Following several minutes of hypnotic involvement, the patient was given “analgesic suggestions” including request for numbness, topical anaesthesia, local anaesthesia, glove anaesthesia, and switchbox - Please see above descriptions for other studies by same authors (e.g., Liossi 2003) for more information about these components. The session ended with a post-hypnotic suggestion that the hypnotic experience would be repeated and would provide comfort during the actual medical procedure, when the therapist would stroke the child’s cheek. It was also mentioned that the application of EMLA 60 min before the LP would be an additional cue for the child to start relaxing and start feeling calm and ready for the procedure to follow.

2. EMLA + Attention (n = 15): Elements of the intervention included development of rapport, non-medical play, and non-medical verbal interactions. New coping skills were not introduced. During sessions, child and therapist were usually discussing school and extracurricular activities as well as playing board games or assembling model airplanes or building brick walls, depending on the child’s age and interests. Overall, the therapist was supportive and warm, encouraged the child to express freely his or her interests, and formed a close relationship with the child.

3. EMLA only (n = 15): All patients received standard interventions provided by the hospital staff for pain control during LPs (i.e., medical and nursing staff offered information, support, and reassurance, and EMLA cream was applied approximately 60 min before the procedure).

Outcomes1. Child self-reported pain using the Wong-Baker FACES Pain Rating Scale
2. Observer ratings of child distress and discomfort using the Procedure Behavior Checklist (PBCL)
3. Hypnotic ability assessed using a Greek translation of the Stanford Hypnotic Scale for Children (SHCS-Children)
NotesWe used a total N of 30 for this study (instead of 45) because we only assessed 2/3 conditions (EMLA + Hypnosis versus EMLA + Attention). Outcomes were assessed at various time points; however, for this review we only used the outcomes assessed closest to the procedure (i.e., during the procedure or after the procedure if a during procedure outcome was not available).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"randomly allocated…with the use of a table of random numbers" p.308 Par 9
Allocation concealment (selection bias)High riskUse of an open random allocation schedule (e.g., random number table)
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasLow riskAppears to be free of other bias that would affect outcomes
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

Liossi 2009

MethodsAllocation: randomly allocated using a computer-generated random positive integers, "computer generated randomization sequence"
Participants

Needle: venepuncture for blood sampling

Inclusion:

-Greek-speaking patients with cancer

-between 7-16 years who were off active treatment and undergoing regular venepuncture as part of disease status monitoring

-had one parent in attendance

Exclusion:

-major affective psychiatric disorders within last 5 years

-concurrent treatment during project with analgesic or psychotropic meds

-no clearly visible veins as judged by nursing performing procedure

-excluded parents if had diagnosis of anxiety or mood disorder or other psychiatric diagnosis in past 5 years

N: 30

Age: 6-14

Gender: M=14, f=16

Diagnosis: Paediatric outpatients

Setting: haematology/oncology clinic of hospital

Interventions

1. EMLA + Hypnosis (n = 15): The hypnosis session included an induction which was adapted according to the child’s age, interests and cognitive and social development. References to patient well-being, strengths, competence, and comfort were also included in the inductions. Following several minutes of hypnotic involvement, the patient was given ‘‘analgesic” suggestions, including request for numbness, topical anaesthesia, local anaesthesia, glove anaesthesia, and switchbox – Please see above descriptions for other studies by same authors (e.g., Liossi 2003., Liossi 2006) for more information about these components. The session ended with a post-hypnotic suggestion that the hypnotic experience would be repeated and provide comfort during the actual medical procedure when the parent would stroke the child’s hand not receiving the venepuncture. It was also mentioned that in the future, the application of EMLA 60 min before the LP would be an additional cue for the child to start relaxing and feeling calm and ready for the procedure to follow. Following that, children in the EMLA + Hypnosis group were taught self-hypnosis following an abbreviated version of Gardner’s model.

2. EMLA + Attention (n = 15): The attention control procedure was similarly based on manuals developed in our previous studies. Patients in the attention control group spent identical amount of time with the therapist as did patients in the hypnosis group, to control for professional attention. However, the therapist did not lead the attention control patients in imagery, relaxation, or other coping skills. Rather, the therapist developed rapport with the patient and engaged in nonmedical verbal interactions about topics such as extracurricular activities, school, and sports.

Both the hypnosis and attention control sessions were delivered to patients individually by the same therapist according to the study protocol manual and were standardized to last 15 min.

3. EMLA only (n = 15): Treated only with EMLA cream applied to the intact skin for approximately 60 minutes before the procedure. The other two groups also received the same EMLA application.

Outcomes

1. Self-Report 100mm VAS pain (range 0-10)

2. Self-Report 100mm VAS of needle-related anxiety

3. Behavioural Measure of Distress: Procedure Behavior Checklist (PBCL)

4. Parent Self-Reported Anxiety using 100mm VAS (i.e., parents rated their own anxiety)

NotesThe study involved 3 time points (Time 1, Time 2, and Time 3) but we only included Time 1 which occurred during the venepuncture and closest to the intervention. Times 2 and 3 were 3 and 6 months after the initial session and did not involve therapist-led intervention; therefore, they were not included in this review. Also, we used a total N of 30 for this study (instead of 45) because we only assessed 2/3 conditions (EMLA + Hypnosis versus EMLA + Attention).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskp.256 Par 4 randomly allocated using computer-generated random positive integers
Allocation concealment (selection bias)High riskUsed an open random allocation schedule p.256 par 11
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasLow riskAppears to be free of other bias that would affect outcomes
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

McCarthy 2010

MethodsAllocation: "randomly assigned"
Participants

Needle Procedure: IV needle insertion

Inclusion:

-4-10 years of age undergoing a scheduled IV needle insertion for a diagnostic medical procedure

Exclusion:

-developmental disabilities

-limited English language skills to answer study questions

-children with cancer

N: 542

Age: 4-10

Gender: F=262, M=280

Diagnosis: gastro clinic (45%), nephrology (17%), endocrinology (12%), pulmonary (8%), cardiology (3%), 12% from other clinics (primarily radiology)

Setting: 3 Midwestern children's hospitals

Interventions

1. Parent Distraction Coaching Training (n = 293): In this condition, one parent was asked to volunteer to be the child’s main support person (coach) in the treatment room during the IV procedure. The designated parent received the multifaceted 15-min intervention on how to provide distraction coaching, which included educational materials, a video, and discussion with a research assistant. The parent and child then selected distracters such as books, toys, and video games. Questions were answered, and practice with the distracters was encouraged.

2. Routine Care Control (n = 249): Families randomized to the control group received routine care in the clinic, and the parent was encouraged to do whatever he or she normally did to help the child during a medical procedure. Distraction items were clearly visible in the treatment room and available to the parent, but there was no direction to use them.

Outcomes

Pain:

Self-report: Oucher

Anxiety/Stress:

Caregiver/parent: Parent report of child distress using 1-item from the perception of procedures questionnaire ("how stressed was your child today during the IV procedure?")

Observational: OSBD-R -higher score = more distress, videotaped and coded later

Physiology: salivary cortisol, "measured by % change in cortisol levels between the matched clinic and baseline cortisol levels"

NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
High riskConsiderable variation in numbers of missing data across outcomes; reasons not provided
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely
Other biasHigh riskHad a potential source of bias likely to influence outcome (e.g., "control group contamination" p.137)
Blinding of participants and personnel (performance bias)
All outcomes
High riskAlthough authors report blinding of personnel, parents aware of group assignment
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of parent-reported outcome assessment

Nguyen 2010

MethodsAllocation: randomization was carried out using opaque envelope, half of which contained a paper that said "music" and half that said "no music"
Participants

Needle procedure: lumbar puncture

Inclusion:

-children with leukaemia

-aged 7-12 years

-were due to undergo LP at oncology ward at NHP, Hanoi

Exclusion:

-significant hearing or visual impairments

-cognitive disorder

N: 40

Age: 7 to12

Gender: F=15, M=25

Diagnosis: children with leukaemia

Setting: Hospital/oncology ward. NHP, Hanoi, Vietnam

Interventions

1. Music (n = 20): Music via earphones. Children chose songs they liked (traditional Vietnamese songs and children's songs) played into earphones from an iPod ® (portable music player with earphones).

2. Control (n = 20): Earphones without music were used.

All the children were given identical pre-procedural information about the procedures and the study. The children were instructed on how to use the iPod® before entering the procedure. In the investigation room, the child put on the earphones and did or did not listen to music, according to his/her group, 10 minutes before the LP procedure started. At the same time, the physician and nurses washed their hands and prepared the chemotherapy. Apart from the child, the parent, physician, and nurse were present in the room during the procedure.

Outcomes

Pain:

Self-Report Numerical Rating Scale (NRS; range 0-10) administered before, during and after LP

Anxiety:

Short form of the Spielberger State-Trait Anxiety Inventory (STAI; range 6-24) assessed before and after LP

Physiological measures of anxiety:

Heart Rate, Blood Pressure (Systolic and Diastolic), Oxygen Saturation, and Respiratory Rate

NotesOutcomes were assessed at various time points (e.g., before, during, and after procedure). For this review, we used 'during' outcomes when available, and when not available, we used 'after' outcomes.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Low riskUnclear if all appropriate safeguards taken with assignment envelopes (i.e. sequentially numbered or sealed)
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasUnclear riskPotential source of bias related to measurement of outcomes
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

Noguchi 2006

MethodsAllocation: Based on a randomly-generated sequence of numbers
Participants

Needle Procedure: "at least one of the following injections.." (i.e., immunization(s))

Inclusion:

-between 4-6.5 years old

-would be receiving one or more injections

-were able to comprehend English well enough to understand and complete the focus of attention task

Exclusion:

-none given

N: 62 (final analysis)

Age: 4-6 years old

Gender: F=26, M=38 (not clear if 2 excluded participants were boys or girls)

Diagnosis: Pediatric patients but presumed healthy

Setting: 3 medical clinics, United States

Interventions

1. Musical Story Distraction (n = 21): A focus of attention task was designed around a musical recording for children entitled ‘Little Squirrel’, which contained lyrics that told a story about a little squirrel and the things he did one day. The song was performed by a male vocalist and included an instrumental accompaniment.

2. Non-Music/Spoken Story Distraction (n = 21): The non-music/spoken version of the same story was recited at the same tempo by a male volunteer.

Both stories (music and spoken) were recorded onto a CD-R. These selections, each 1 minute and 56 seconds in duration, were presented to the participants via a portable CD player and headphones. For the purpose of infection control, the headphones were wrapped with fresh pieces of plastic wrap each time they were used by a participant. Visual aids depicting events and characters in the story were created using clip art. There were five event visuals: squirrel shaking tail, squirrel wiggling nose, squirrel digging a hole, squirrel cracking a nut, and squirrel taking a nap. There were also five animal character visuals: mouse, owl, rabbit, bee, and dog. Velcro backings were placed on the ten laminated visuals, and were presented to the participants on a Velcro board. The child was told by the examiner that he/she would be listening to a “story about a little squirrel who did many things and saw many animals while he was running around”. The experimenter then labeled the squirrel action visuals one at a time, stating what action was taking place (e.g., ‘he shook his tail’) and pointing at the corresponding picture on the Velcro board. The experimenter asked the child to state what was happening in each picture. In situations when the child did not state the action, the experimenter asked a yes/no question (e.g., ‘Is he wiggling his nose in this picture?’) and restated what action was taking place. The animal visuals were presented in a similar manner. Children were told to listen carefully to the story because they would need to point to the various pictures to answer questions about the story. If the child became distracted from the task by the injection process, the experimenter attempted to redirect the child to the activity by using phrases such as “keep pointing” and “look at the pictures”. In instances when the injection procedure lasted longer than the CD recording, the recording was replayed. The child was reinforced by the examiner throughout the procedure for pointing behaviours (e.g., “Good pointing”) and provided with reassurance (e.g., “It’s almost done. You’re doing a good job”) as warranted.

3. Standard Care Control (n = 20): When the nurse left the room to prepare the syringe(s), the experimenter and observer positioned themselves in the doorway of the exam room, in an attempt to keep their interactions with the parent/guardian and child to a minimum.

Outcomes

Pain:

Self-Report: Faces Pain Scale (FPS)

Nurse/health Professional: FPS (as rated by the experimenter and trained observer)

Anxiety/Distress:

Behavioral: Observational Scale of Behavioral Distress (OSBD)

NotesThe data for the music and non-music story distraction conditions were pooled together to create one overall distraction treatment condition. Outcomes were assessed at 3 time points or phases (pre-injection, injection, and post-injection). For this review, we used data from the injection phase. Also, the distraction conditions included reassurance which has been shown in other studies to be distress promoting.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"randomly assigned…based on a randomly-generated sequence of numbers" p. 19 Par 1
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasHigh riskMultiple potential sources of bias related to study design and other problems
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Press 2003

MethodsAllocation: Randomized - no further details
ParticipantsNeedle Procedure: venepuncture
Inclusion:
-ages 6-16 years undergoing venepuncture
-conscious
-Hebrew-speaking
-no hearing problems
Exclusion:
-none given
N: 94
Age: 6-16 years
Gender: M = 57, F = 37
Diagnosis: none
Setting: Pediatric Emergency Department of the Saroka University Medical Center, Israel
Interventions

1. Uncertainty Reduction + Active Distraction (n = 48): Uncertainty reduction: one of the two attending nurses told the patient: "Today you and I will do everything to make you feel good during the test. I'll show you how you can help yourself feel good". Active distraction: the child was shown a pair of headphones, was asked what they were, was offered to touch them, and instructed the put them on his/her ears. The child was told "I'll put a song on for you, listen to is until the end, and wait for a question about it". This was intended to produce active listening and more cognitive demands during the distraction. After hearing the song (and completing the venepuncture) the nurse asked the child a question about the song's content (the same question for all children in the experimental condition).

2. Usual Care control (n = 46): For both the experimental and control groups, nurses provided usual care for reducing the child's pain and distress (calming words, soothing encouraging parental help, etc).

Outcomes1. Child self-report of pain during venipuncture using a 10 cm VAS combined with a faces pain scale
2. Parent and nurse ratings of child pain using the same 10 cm VAS and faces pain scale
3. Physician measured pressure/pain threshold of children using a dolorimeter positioned on 13 points throughout the body
NotesParent and nurse VAS ratings were pooled together to create one overall 'observer-reported pain' score. Also, for this review, we classified the treatment condition (Uncertainty Reduction + Distraction) as 'Distraction' because based on the definition described in the study, it did not appear to represent an additional intervention technique, and was not overly different from statements made to participants in other distraction-based studies.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasHigh riskHad a potential source of bias related to the specific study design (e.g., modified pain measure)
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Sinha 2006

MethodsAllocation: randomly assigned by a patient allocation scheme implementing a stratified block design to ensure equal gender
Participants

Participants:

Needle Procedure: laceration repair

Inclusion:

-children between 6-18 years of age visiting the ED for laceration repair between 12noon and midnight

-had sustained an uncomplicated laceration involving only the skin and subcutaneous tissue, <5cm in length which could be repaired using basic suture repair techniques

Exclusion:

-children presenting with multiple lacerations, greater than or equal to 1 complex laceration, or a laceration associated with other injuries

-patients who were unable to understand or fully participate in the informed consent process or study protocol, for whatever reason

N: 240

Age: 6-18 years

Gender: F=120, M=120

Diagnosis: included only children who sustained an uncomplicated laceration involving only the skin and subcutaneous tissue, <5cm in length, only single laceration included

Setting: Hospital (emergency department)

Interventions

1. Distraction (n = 120): Children were given a choice of age-appropriate distractors including music, video games, or cartoon video. For children who did not show interest in any of these distractors, a certified child life worker offered to read a book or help blow bubbles during the procedure. A CD player with headphones was provided for those selecting music distraction, and subjects were given a choice of music. Children in this group received distraction plus the standard care received in the control group.

2. Standard Care Control (n = 120): To minimize compensatory rivalry and resentful demoralization in the control group, time allocated to patients was identical regardless of study group assignment. The experienced ED child life staff explained to children in both groups what he or she might experience during the procedure by using developmentally appropriate words and in a non-threatening manner.

Outcomes

Pain:

Self-report: 7pt Facial Pain Scale

Anxiety/Distress:

Self-Report: State Trait Anxiety Inventory for Children (STAIC) was only administered to children over the age of 10 years. It distinguishes between transitory anxiety (state anxiety) and general anxiety proneness (trait anxiety). In this study, the state anxiety scale was used to measure situational anxiety in children before and after laceration repair

Caregiver/Parent report:100-mmVAS to measure pain distress (range: no distress-most distress). Before and after laceration repair

NotesSDs were not reported in the paper. However, we were able to calculate SDs from the data available, and these SDs were used in the data analyses. Although the STAIC outcome was only used with children 10 years and older rather than the full sample, we still included this data in our analyses.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskUnclear if all appropriate safeguards taken with assignment envelopes (i.e., opaque)
Incomplete outcome data (attrition bias)
All outcomes
Low riskReported missing data did not impact outcomes
Selective reporting (reporting bias)Low riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasHigh riskMultiple potential sources of bias related to study design and other problems (e.g., "heightened awareness of distraction techniques amongst ED personnel" p. 1167)
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report and parent-report outcome assessment

Tak 2006

MethodsAllocation: Randomized - no further details
Participants

Needle Procedure: venepuncture
Inclusion:

-Dutch patients receiving a venepuncture
Exclusion:

-children of non-Dutch parentage
N: 94
Age: 3-12 years (mean = 6.4, SD = 2.5)
Gender: M = 73, F = 63
Diagnosis: none
Setting: outpatient centre of the St Antonius Ziekenhuis in Nieuwegein (the Netherlands)

Interventions

Definitions for the following condition components are provided below.

1. Placebo, Distraction, Information (n = 20)
2. EMLA, Distraction, Information (n = 21)
3. Placebo, Information (n = 20)
4. EMLA, Information (n = 21)
5. Information (n = 26)
6. Non-Treatment Control (n = 28)

Distraction: During the venepuncture, a funny 6-minute fragment of a video cartoon (Walk Disney's 'The Beauty and the Beast') was shown. Sound could be heard through a headphone.

Procedural Information: All children except those in the control groups received information on the venepuncture by means of a photo book. The supervising research assistant asked the child to read the book with his/her parent(s) while in the waiting room. The 24 photos, each accompanied by a short and simple text, showed step by step what was to come from entrance to departure from the hospital. A boy 8 years old acted as the model.

EMLA: Eutectic mixture of local anaesthetics (EMLA) cream was applied by the laboratory personnel on duty who did not know whether the cream was EMLA or a placebo type of cream. These were not necessarily the same persons as those who did the pricking.

Placebo: A placebo cream was applied by the laboratory personnel on duty who did not know whether the cream was EMLA or a placebo type of cream. These were not necessarily the same persons as those who did the pricking.

*Because EMLA requires 1 hour to produce its effect, the children in the four ‘cream conditions’ passed that time in the waiting room in the presence of their parent(s).

Non-Treatment Control: No treatment provided.

Outcomes1. Child self-reported pain using the Oucher scale for children younger than 6 years, and the VAS which children of 6 and over - a research assistant administered these scales immediately after the venepuncture
2. Research assistant ratings of child distress using the Groningen Distress Scale (GDS), a 5-point categorical behavioral observation scale of distress based on three categories: breathing, crying, and muscle tone - scored at three time points (when child entered room, just before venepuncture, and during venepuncture)
NotesWe used a total N of 94 for this study (instead of 136) because we only assessed 4/6 conditions (i.e., Placebo, Distraction, Information versus Placebo, Information and Information versus Non-Treatment Control). Although GDS ratings were calculated at three time points in this study (child entering the room, just before venepuncture, and during venepuncture), we only used the 'during venepuncture' scores in the analyses for this review.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo reasons for missing data provided
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Tyc 1997

MethodsAllocation: Randomized - no further details
ParticipantsNeedle Procedure: IV insertion prior to MRI
Inclusion:
- ages 6-18 years old and English-speaking
- scheduled to receive a magnetic resonance imaging (MRI) procedure of the brain or spine
- had received at least one prior MRI procedure at St Jude's Children's Hospital within the last 12 months
-in remission or had stable disease, or both
Exclusion:
- patients who had relapsed or had evidence of progressive disease or had severe cognitive deficits, or both (IQ < 70) based on medical chart review, psychosocial histories, or available psychological assessment data
N: 55
Age: 6.3-18.6 years (mean = 12.5 years)
Gender: M = 50.9%, F = 49.1%
Diagnosis: Approximately 27% = medulloblastoma, 24% = CNS glioma, and 49% = variety of malignant CNS neoplasms
Setting: St Jude's Children's Hospital, Tennessee
Interventions

1. Cognitive-Behavioural Treatment (CBT) (n = 28): The CBT intervention consisted of a package of five components including: (a) filmed modelling (two age appropriate versions of a 15-minute film that depicted the steps involved in preparation of the MRI procedure), (b) breathing exercises (patients learned both passive and active breathing exercises as modeled in the film such as instructions to breathe at a slower than normal rate while focusing on rhythmic breathing), (c) emotive imagery/distraction (focus on emotive images including heroes like “Superman” or pleasant mental images like beaches that were incompatible with distress), (d) behavioral rehearsal (involved two tasks including practice for starting and IV and an MRI simulation task that provided the opportunity to lie still inside the MRI), and (e) positive incentive (showing the child a small trophy and saying he/she could win the trophy by “doing the best they could do”).

2. Standard Care Control (SCC) (n = 27): Prior to their procedures, patients in this group had the opportunity to discuss details about the MRI procedure with the MRI technologist and also view the magnet. This is the standard preparation for the MRI exam at this institution. Patients did not, however, receive additional intervention from the Psychology staff.

Outcomes

1. Child self-report of anxiety using the State-Trait Anxiety Inventory for Children (STAI-C)

2. Child, parent, and staff ratings of child IV distress

3. Chid, parent, and staff ratings of child MRI distress

4. Staff MRI Distress Ratings
5. MRI Behavior Checklist

NotesParent and staff IV distress ratings were pooled together to create one overall 'observer-reported distress' outcome. Only outcomes related to the IV (not the MRI) were used in the analyses for this review. The STAI-C scores were used in this study to assess background variables, therefore they were not included in the analyses for this review.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasHigh riskMultiple potential sources of bias related to study design and other problems
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Vessey 1994

MethodsAllocation: Randomized - using table of random numbers
ParticipantsNeedle Procedure: routine blood draws
Inclusion:
- must have had two or fewer blood draws in the six months preceding the procedure
- free of chronic conditions
- fluent in English
Exclusion:
- none given
N: 100
Age: 3.6-12.11 years (mean = 7.4 years, SD = 3.3 months)
Gender: M = 62%, F = 38%
Diagnosis: none
Setting: Ambulatory Care Clinics of a children's hospital in the south central United States
Interventions

1. Distraction (n = 50). Subjects were given the Illusion Kaleidoscope to look through during the blood draw. This toy was selected since it requires no manipulation to change images; rather, glitter suspended in a fluid-filled tube (space tube) passes before the lens when held to the eye. The subjects were encouraged to concentrate on what they were seeing by phrases such as, "Do you see the different designs?”

2. Standard Care Control (n = 50): Subjects received standard preparation that consisted of being comforted by physical touch and soft voices.

Outcomes1. Child self-report of pain using the Wong-Baker FACES Pain Rating Scale (FACES)
2. Investigator ratings of child pain using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
NotesThe authors found that age was a significant covariate, whereby younger children reported perceiving greater intensities of pain and demonstrated more active observable behavioural distress to the venepuncture that the older children. They provided adjusted means (but not adjusted SDs). Since the adjusted means were only slightly different from the original means, we used the original means and SDs for the analyses in this review.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"subjects were randomly assigned…using a random number table" p.370 Par 10
Allocation concealment (selection bias)High riskUse of an open random allocation schedule (e.g., random number table)
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

Vosoghi 2010

MethodsAllocation: RCT - convenience sample
Participants

Needle Procedure: IV Insertion

Inclusion:

-3-6 years of age

-orientation to time, place and people

-ability to make verbal communication

Exclusion:

-pain, seizure, or any life-threatening condition

-administration of pain killers

-insertion of more than one catheter

-time of attempting to insert the catheter more than 60 seconds

N: 72

Age: 3-6 years old

Gender: F=35, M=37

Diagnosis: 57 patients with a diagnosis of infectious diseases and 15 with a diagnosis of internal medicine diseases. No healthy children

Setting: Emergency department of a children's hospital

Interventions

1. Distraction (n = 36): Two minutes before the IV insertion, distraction was done using a bubble maker (i.e., a train that whistles and makes bubbles while moving) and was continued until the end of the procedure.

2. Control (n = 36): Same overall study procedure for all participants (e.g., heart rate and oxygen saturation were assessed 3 minutes after the catheter was fixed, pain assessment was completed 10 minutes after catheterization), but in this control group, no distraction was administered.

Outcomes

Pain:

Self-Reported: OUCHER - was done 20 min after the procedure

Physiological measures:

Heart rate (pre/post-intervention), Oxygen Saturation (pre/post-intervention)

NotesThis was an article in Farsi and we had a translator help us with data extraction. For study exclusion criteria, the authors did not explain what they meant by 'pain' but presumably this was pain not explicitly due to the needle procedure. In addition, although means and SDs for the OUCHER were not reported in the paper, these were obtained via contact with the study authors.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient reporting of exclusions to permit judgment of 'low' or 'high' risk
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely to include in meta-analyses
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists
Blinding of participants and personnel (performance bias)
All outcomes
High riskNo mention of blinding but nature of psychological intervention precludes this
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of outcome assessment

Wang 2008

MethodsAllocation: according to random numbers from 1-300 by research randomizer
Participants

Needle Procedure: venepuncture

Inclusion:

-8-9 years old requiring initial venepuncture for a period of intravenous treatment in the paediatric department

Exclusion:

-history of puncture during the past 3 months

-treatment with anxiolytic or narcotic analgesics medication 72h prior to the venepuncture

-presence of insufficient mental development, alteration of mental status and cognitive impairment

-visual and auditory deficits

N: 300

Age: 8-9 years old

Gender: F=154, M=146

Diagnosis: pneumonia, asthma, encephalitis, allergic purpura

Setting: "pediatric department" in hospital, China

Interventions

1. Audiovisual Distraction (n = 100): Patients were given a choice of 10 appropriate cartoon videos. A TV set coupled with a DVD player was provided for patients to play their favourite animated cartoons. During the showing of the cartoon films (about three minutes after the film began), venepuncture was performed by a registered nurse.

2. Psychological Interventions (n = 100): Patients received conventional psychological interventions in a fixed scheme delivered by a research nurse (e.g., comfort provided, procedure explained, therapeutic touch, guided imagery, and encouragement) with no audiovisual distraction. The intervention methods, including explaining before venepuncture, therapeutic touch, encouragement and guided imagery during the procedure, were actualized by utilizing developmentally appropriate words and in a non-threatening manner.

3. Control Condition (n = 100): Patients underwent venepuncture without any special intervention (i.e., no audiovisual distraction or psychological interventions).

Outcomes

1. Self Report Pain: 10 cm Visual Analogue Scale (VAS)

2. Cooperative Behaviour Scale of Children in Venepuncture (CBSCV): Scale created by authors and used by research nurses to evaluate the cooperation of children in the three groups

NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"randomly assigned…according to random numbers…generated for Research Randomizer" p. 580 Par 6
Allocation concealment (selection bias)Unclear riskUnclear if all appropriate safeguards taken with assignment envelopes (i.e., opaque)
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Other biasHigh riskHad a potential source of bias related to significantly different to length of procedure time (p.581)
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

Windich-Biermeier 2007

MethodsAllocation: "randomly assigned using an SPSS pseudo-random number generator"
Participants

Needle Procedure: venous port access or venepuncture

Inclusion:

-5-18 years old

-able to understand and speak English

-able to hear and see

-had a diagnosis of leukaemia, lymphoma, a solid tumor, or histiocytosis

-were receiving chemotherapy

-had a physician's order for a port access/venepuncture

-had at least one previous access/venepuncture

Exclusion:

-youth with cancer excluded if they were septic, dehydrated, vomiting, sedated, medically unstable, diagnosed with mental illness, or scheduled for another procedure following the port access/venepuncture

N: 50

Age: 5-18 years old

Gender: F=23, M=27

Diagnosis: cancer

Setting: Hospital - University affiliated regional, paediatric medical centre

Interventions

1. Parent Coaching + Child Distraction (n = 22): In addition to standard care, the intervention group also used a self-selected distracter. Participants chose one from a pool of five distracters including: (a) the I Spy Super Challenger book where parents asked their child to look for hidden pictures or items on the page among various graphic designs, (b) bubbles (parents below bubbles using a magic wand, (c) music table (vibroacoustic music felt through speakers built into the mattress of the procedure table; sound is heard via speakers and also channeled through headphones; children selected a 45-minute music CD of music from Radio Disney-Kid Jams and other children’s classics), (d) Virtual Reality glasses (similar to oversized sunglasses with attached earphones, showing a 3D video with stereo-sound music), and (e) Nintendo Gameboy (handles gaming device with colour screen displaying fast-moving action packed games with sound effects). After the participant selected a distracter, the parent was instructed by one of the co-investigators using a standardized script, to actively coach the child to use the distraction item. During the procedure, the participants were repeatedly encouraged by their parents to focus all of their attention on the distracter instead of the procedure. Just prior to beginning the procedure and during the procedure, the parent provided constant and repeated verbal distraction cues to the patient (e.g., “Help me find the rabbits on this page”, “Can you count the number of bubbles in the air?”, etc).

2. Standard Care (n = 28): The comparison group received standard care including: (a) a full explanation of the procedure given to the participant and parent, (b) parental presence at the participant’s side during the procedure for support, and (c) use of a topical anesthetic over the needle puncture site (either EMLA or Fluori-Methane, depending on participant/parent preference), which is the standard practice for all non-emergent needle stick procedures).

Outcomes

Self Report:

Pain: Color Analogue Scale (bottom narrow/no pink color -> no pain/hurt/top wide, very red -> worst pain/hurt)

Anxiety/Distress:

Self Report: Glasses Fear Scale (a type of VAS to asses fear) - empty cylinder = no fear, filled cylinder = worst fear

Caregiver/Parent report: assessed child's fear pre and post-procedure

Nurse/Health professional report: assessed child's fear pre and post-procedure

Behavioural Measure of Distress:

Observation Scale of Behavioral Distress (OSBD) assessed by nurse pre and post-procedure

Other Outcome(s):

Investigator-developed IV Poke Questionnaire (IPQ) used by nurse to interview participants (IPQ-Subject) and their parents (IPQ-Parent) about their experiences during the port access/venepuncture

NotesData for parent-reported fear, nurse-reported fear, and OBSD broken down by group (intervention versus control) were not reported, and therefore could not be included in the analyses for this review. Also, although the authors label the intervention as "distraction", they describe it as involving distraction with parent coaching. Therefore, we classified it in the 'Parent Coaching + Child Distraction' intervention category for this review. Lastly, the intervention and control groups differed in terms of various variables (e.g., type of topical analgesic used, parental presence, number of cannulation attempts); however, there were no statistically significant differences between the groups on any of these variables.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"randomly assigned using an SPSS pseudo-random number generator" (p.9)
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely
Other biasUnclear riskInsufficient information to assess whether an important risk of bias exists
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

Wint 2002

MethodsAllocation: Randomized - no further details
ParticipantsNeedle Procedure: lumbar puncture (LP)
Inclusion:
- between the ages of 10-19 years being treated for cancer
- receiving LPs as part of therapy and undergoing at least a second LP
- all ethnicities, and able to understand and communicate in English
- able to hear and see
Exclusion:
- none given
N: 30
Age: 10-19 years
Gender: M = 16, F = 14
Diagnosis: Acute Lymphoblastic Leukaemia = 20, B-cell Lymphoma = 1, Lymphoma = 1, T-cell = 2, T-cell ALL = 4, T-cell Lymphoma = 2
Setting: private, in-hospital clinic treatment room within a 322-bed paediatric teaching hospital in the southwest United States
Interventions

1. Virtual Reality (VR) Distraction (n = 17): Adolescents in this wore VR glasses during their LPs, in addition to receiving standard nursing care. The glasses were similar to oversized sunglasses with earphones attacked. Subjects were placed in the standard side lying position for their LPs with a videocassette recorder/television placed at eye level. They all watched the same video through the glasses, which provided 3D viewing, and listened to music in stereo sound. The VR video entitled ‘Escape’ included 64 minutes of footage and contained experiences of skiing down the Swiss Alps, explosive drag racing, a stroll down Paris sidewalks, and visions of quiet mountain streams. Prior to conscious sedations, nurses used a standardized script to explain the purpose of the VR glasses to subjects and the need to focus their attention on what they were hearing and seeing instead of on the discomfort of the procedure. The subjects started watching the video when placed on the procedure table at the beginning of the LP and finished when the sedation recovery criteria were met.

2. Standard Care Comparison (n = 13): Adolescents in this group received standard nursing care for an LP including: (a) weight-based conscious sedations using Fentanyl and Midazolam, (b) 2.5 grams of EMLA cream applied at the spinal injection site, (c) a full explanation of the LP given to them and their parent, and (d) parental presence at their patient’s side for support. Although subjects received sedation, they were cognitively aware of the environment and able to respond, move, and verbalize discomfort and anxiety during the LP.

Outcomes1. Child/Adolescent self-report of pain using 100 mm vertical VAS
2. Nurse ratings of child's sedation level following the LP using the Sedation Assessment Scale
3. Investigator developed ten-item questionnaire completed by the children/adolescents to determine their experiences during the LP in both groups, and the subjective experience of the VR glasses by those in the experimental group
NotesNone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment of 'low' or 'high' risk
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)High riskOne or more outcomes of interest are reported incompletely
Other biasHigh riskMultiple potential sources of bias related to study design and other problems (e.g., small and unequal sample size)
Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy participants and personnel  were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of self-report outcome assessment

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Agarwal 2008Older than included age range/adult sample
Alavi 2005Cross-over design with data not available pre-crossover
Alderfer 2010Inappropriate outcome measures/outcomes not related to pain or anxiety
Alhani 2010Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Anghelescu 2013Intervention not primarily psychological
Anson 2010Older than included age range/adult sample
Arts 1994Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Ashkenzai 2006Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Atkinson 2009Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Bagnasco 2012Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Baxter 2011Inappropriate intervention/cannot isolate effects of psychological components from multi-component intervention
Bengston 2002Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Berberich 2009Only one group received an adjunct pharmacological intervention
Boivin 2008Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Bowen 1999Failed randomization
Broome 1998No control/comparison group or inappropriate control group
Bruck 1995Inappropriate outcome measures/outcomes not related to pain or anxiety
Bufalini 2009Use of general anaesthesia/conscious sedation prior to needle procedure
Bufalini 2012Conference presentation abstract/not a published RCT
Carlson 2000Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Chen 2000bMet inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Christiano 1996Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Cline 2006Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Cohen 1997Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Cohen 1999?
Cohen 2001Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Cohen 2002Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Cohen 2010Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Cramer-Berness 2005Younger than included age range/infant sample
Crowley 2011Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Dalhquist 2002Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Dalhquist 2005Secondary data analysis/original study not included in review
Davit 2011Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Demir 2012Intervention not primarily psychological
Drahota 2008Older than included age range/adult sample
Dufresne 2010Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
El-Sharkawi 2012Cross-over design with data not available pre-crossover
Fassler 1985Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
French 1994Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Gilbert 1982Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Goymour 2000Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Hatava 2000Surgical procedure
Hawkins 1998No control/comparison group or inappropriate control group
Heckler-Medina 2006Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Heden 2009Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Hoffman 2011Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Howe 2011Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Inal 2010Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Jacobson 2006Older than included age range/adult sample
Jay 1987Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Jay 1990Inappropriate outcome measures/outcomes not related to pain or anxiety
Jay 1991Inappropriate intervention/cannot isolate effects of psychological components from multi-component intervention
Jay 1995No control/comparison group or inappropriate control group
Kain 2006Use of general anaesthesia/conscious sedation prior to needle procedure
Kammerbauer 2011Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Kazak 1996Means or standard deviations, or both, not available
Kazak 1998Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Kettwich 2007No needle procedure
Klingman 1985Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Klorman 1980Surgical procedure
Kolk 2000No control/comparison group or inappropriate control group
Krauss 1996Non-published dissertation study
Kuttner 1988Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Kwekkeboom 2003Older than included age range/adult sample
Lawes 2008Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Lessi 2011Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Liossi 2007Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Lustman 1983Surgical procedure
MacLaren 2005Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
MacLaren 2007Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Malone 1996Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Manimala 2000Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Manne 1990Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Manne 1994Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Marec-Berard 2009Intervention not primarily psychological
McCarthy 1998Failed randomization
McCarthy 2010bResults not presented separately as control versus treatment group/secondary analysis and original study included in review
McInally 2005Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Megel 1998Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Melamed 1974Surgical procedure
Myrvik 2009Non-published dissertation study
Nilsson 2009Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
O'Laughlin 1995Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Olsen 1991Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Ozdemir 2012Younger than included age range/infant sample
Park 2008Intervention not primarily psychological
Pederson 1996Fewer than five participants per condition
Peretz 1999Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Posner 1998Non-published dissertation study
Powers 1993Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Ramponi 2009Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Reeb 1997Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Rogovik 2007Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Russell 2012Failed randomization
Salih 2010Older than included age range/adult sample
Santos 1999Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Schechter 2010Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Schneider 2011Older than included age range/adult sample
Schur 1986Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Shabanloei 2010Older than included age range/adult sample
Shahabi 2007Cross-over design with data not available pre-crossover
Shimizu 2005Older than included age range/adult sample
Sikorova 2011Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Slack 2009Older than included age range/adult sample
Slifer 2009No control/comparison group or inappropriate control group
Slifer 2011Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Smith 1989No control/comparison group or inappropriate control group
Smith 1996No control/comparison group or inappropriate control group
Sparks 2001Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Stefano 2005Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Stevenson 2005Inappropriate intervention/cannot isolate effects of psychological components from multi-component intervention
Sury 2010Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Thurgate 2005Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Tufekci 2009Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Vernon 1974Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Vika 2009Older than included age range/adult sample
Vohra 2011Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Wall 1989No control/comparison group or inappropriate control group
Wallace 2010Intervention not primarily psychological
Weber 2010No needle procedure
Weinstein 2003No needle procedure
Winborn 1989Surgical procedure
Wood 2002Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Yoo 2011Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Young 1988Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes
Zabin 1982Non-published dissertation study
Zahr 1998Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment
Zeltzer 1982Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Ancillary