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.
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.
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.
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).
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).
• The Children’s Hospital of Eastern Ontario Pain Scales (CHEOPS) (McGrath 1985)
• The Faces Legs Activity Cry Consolability Scale (FLACC) (Merkel 1997)
• The Observational Scale of Behavioral Distress (OSBD) (Jay 1983)
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).
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 (tcPO
• transcutaneous carbon dioxide tension (tcPCO
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.
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 Chi
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 [SD1
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 Chi
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).
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.
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.
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:
- not a randomized controlled trial, reported assignment not truly random, quasi-randomized assignment (n = 47) (Alhani 2010; Ashkenzai 2006; Atkinson 2009; Bagnasco 2012; Boivin 2008; Christiano 1996; Cline 2006; Cohen 1997; Cohen 2001; Cohen 2002; Cohen 2010; Crowley 2011; Davit 2011; Dufresne 2010; French 1994; Heckler-Medina 2006; Heden 2009; Hoffman 2011; Howe 2011; Kammerbauer 2011; Lawes 2008; Lessi 2011; Liossi 2007; MacLaren 2005; MacLaren 2007; Manimala 2000; Manne 1990; Manne 1994; McInally 2005; Nilsson 2009; Olsen 1991; Powers 1993; Ramponi 2009; Rogovik 2007; Schechter 2010; Schur 1986; Sikorova 2011; Slifer 2011; Sparks 2001; Stefano 2005; Sury 2010; Thurgate 2005; Tufekci 2009; Vohra 2011; Wood 2002; Yoo 2011; Zahr 1998);
- met inclusion criteria but missing data necessary for pooling, such as means, SDs, and cell sizes (n = 23) (Arts 1994; Bengston 2002; Carlson 2000; Chen 2000b; Dalhquist 2002; Fassler 1985; Gilbert 1982; Goymour 2000; Inal 2010; Jay 1987; Kazak 1996; Kazak 1998; Klingman 1985; Kuttner 1988; Malone 1996; Megel 1998; O'Laughlin 1995; Peretz 1999; Reeb 1997; Santos 1999; Vernon 1974; Young 1988; Zeltzer 1982);
- fewer than five participants per condition (n = 1) (Pederson 1996);
- only one group received an adjunct pharmacological intervention (n = 1) (Berberich 2009);
- results not presented separately as control versus treatment group or secondary analysis and original study included in review (n = 1) (McCarthy 2010b);
- secondary data analysis and original study not included in review (n = 1) (Dalhquist 2005).
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 I
Effects of interventions
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 I
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 I
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 I
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 I
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 I
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 I
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 I
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.
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.
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.
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).
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).
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
- Top of page
- Authors' conclusions
- Data and analyses
- What's new
- Contributions of authors
- Declarations of interest
- Sources of support
- Differences between protocol and review
- Index terms
Appendix 1. MEDLINE search strategy
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
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/
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
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
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/
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
[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
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/
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
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
mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer
Appendix 5. IBI Web of Knowledge search strategy
Appendix 6. CINAHL search strategy
Last assessed as up-to-date: 2 September 2013.
Protocol first published: Issue 1, 2005
Review first published: Issue 4, 2006
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
- No sources of support supplied
- 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).
Medical Subject Headings (MeSH)
*Needles; Anxiety [*prevention & control; psychology]; Central Venous Catheters [adverse effects]; Cognitive Therapy [*methods]; Hypnosis; Immunization; Pain [*prevention & control; psychology]; Phlebotomy [psychology]; Punctures [*psychology]; Randomized Controlled Trials as Topic
MeSH check words
Adolescent; Adult; Child; Child, Preschool; Humans