A systematic review of clinical trials affecting anxiety, stress and fear of childbirth in expectant fathers

Abstract Aim To investigate clinical trials affecting anxiety, stress and fear of childbirth in fathers. Design A systematic literature search was conducted based on Cochrane Collaboration statement recommendation and Preferred Reporting Items for Systematic reviews and Meta‐Analyses checklist. Methods With assistance of Medical Subject Headings, keywords were employed to search for relevant trials. Articles published between November 2000–November 2019 were searched in five electronic databases including PubMed, Web of Science, Google Scholar, Scopus and Cochrane as well as Iranian databases. The risk of bias was assessed by Cochrane Risk of Bias Scale. Results A total of eight studies met the inclusion criteria. Interventions were classified into four categories including pre‐natal education, music therapy, massage therapy and relaxation training. The results showed that there is no evidence of a best intervention, but it showed that non‐pharmacological interventions can decrease anxiety, stress and fear of childbirth and increase the positive experience of childbirth in the expectant fathers.

Approximately 13% of fathers experience severe fear of childbirth (Hildingsson et al., 2014). These feelings are most evident during pregnancy as labour approaches, so it seems to be the best time for effective interventions in the third trimester of pregnancy (Escott et al., 2009;Johnson & Slade, 2002). If these feelings are ignored, they may have consequences such as excessive anxiety, stress and fear of childbirth that increase the risk of developing physical and psychological disorders, hypertension, depression and post-traumatic stress disorder (Bergström et al., 2013;Hosseini et al., 2018).
They may affect children's attachment patterns, emotional and cognitive development of the children, couple relationships, father's ability to support their spouses and an unpleasant experience of pregnancy and childbirth (Bergström et al., 2013;Ganapathy, 2015;Hanson et al., 2009).

| BACKG ROU N D
Although single studies with controversial results have been conducted on the management of anxiety, stress and fear of childbirth in the expectant fathers (Bergström et al., 2009;Bergström et al., 2013;Charandabi et al., 2017;Labrague & McEnroe-Petitte, 2016;Latifses et al., 2005;Li et al., 2009;Mihelic et al., 2018;Wöckel et al., 2007), no systematic review has reported the effectiveness of clinical trials to reduce these problems in this group. In this way, it showed that fathers' education in pre-natal period can lead to a positive childbirth experience and reduces their fear (Bergström et al., 2013;Li et al., 2009), although another study failed to approve the effectiveness of prenatal educational programme on couples' stress during pregnancy (Bergström et al., 2009).

According to the International Conference on Population and
Development agenda, the men's involvement in all aspects of sexual and reproductive health matters including pregnancy and childbirth is an important issue to meet safe motherhood (Jamali et al., 2018). So pay attention to the expectant fathers' mental health to support their spouses during pregnancy is a priority. It is important to understand which interventions will most effectively advance expectant fathers' emotional conflicts; therefore, this systematic review was conducted to assess the clinical trials affecting anxiety, stress and fear of childbirth in the expectant fathers.

| Research questions
• Which clinical trials will most effectively advance the expectant fathers' anxiety, stress and fear of childbirth?
• How clinical trials are effective in reducing anxiety, stress and fear of childbirth in the expectant fathers?

| Study design
A systematic literature search was performed based on Cochrane

Collaboration statement recommendation and Preferred Reporting
Items for Systematic reviews and Meta-Analyses checklist (PRISMA) (Higgins et al., 2011;Moher et al., 2011).

| Formulating the research question
As mentioned above, the research question was posed.

| Searching databases
Articles published between November 2000-November 2019 were searched in electronic databases, such as PubMed, Web of Science, Google Scholar, Scopus and Cochrane as well as the Iranian databases including Magiran, IranMedex and Scientific Information Database.
A manual search of references linked to the articles of concern was also conducted. Final search was made on 20 November 2019.

| Extracting articles on the basis of the selection criteria
Initially, through an advanced systematic search the articles were extracted. After omitting repeated cases, the remaining irrelevant articles were eliminated by reviewing title, abstract and the main text. Article selection was done independently by two individual coworkers (Z.Sh and SF.Gh). In the case of a disagreement, selection was done by a third author (F.E). The PRISMA checklist guided the reporting process Moher et al., 2009).

| Inclusion and exclusion criteria
In this review, clinical trials published in the English and the Persian languages addressing the effects of interventions on anxiety, stress and fear of childbirth in the expectant fathers were included. In cases where the full text of the article was not available, the abstract was used. If the abstract did not provide sufficient information, the article was excluded from the study.

| Quality assessment
Included articles were further assessed using Cochrane Risk of Bias Scale which is a recommended tool to assess the risk of bias in the interventional studies. The scale measures biases in case of selection, performance, attrition, reporting and other bias and classifying studies as "low-risk," "high-risk" and "unclear" (Higgins et al., 2011).

| Data retrieval, classification and reporting
Abstracts and main texts of the eligible articles were carefully studied for the retrieval of required data. Finally, collected data were classified and formally presented.

| Search results
Initially, a total of 210,055 articles were retrieved. Duplicates articles were removed by Endnote software, and then, the articles were reviewed by two authors and the irrelevant articles were deleted.
In the next step, 567 papers and full texts of 26 papers were evaluated and eight studies were singled-out in the final selection phase ( Figure 1). Out of those, two dealt with fear of childbirth, four were dedicated to childbirth-related anxiety, one addressed childbirthrelated stress and one concurrently investigated childbirth-related anxiety and stress. General description and methodology of the selected literature are described in Table 1.

| Participants
Participants were fathers whose spouses were pregnant. Among the studies that investigated the fear of childbirth, the maternal gestational age at the time of the study was 19 weeks (Bergström et al., 2013) and 6 weeks (Wöckel et al., 2007). In both studies, mothers were nulliparous. In the study conducted by Bergström et al. (2013), only fathers who reported severe fear of childbirth (based on the Wijma questionnaire that was standardized for Swedish fathers) were recruited. In the study conducted by Wöckel et al. (2007), the severity of childbirth-related fear was not considered as an inclusion criteria.
It was compared in the intervention group versus the control group at the baseline and at the postintervention phase via a researcher-made questionnaire.
In one of the studies, fear of childbirth was assessed by Wijma

Delivery Expectancy/Experience Questionnaire (W-DEQ A/B)
which is a standard tool for measuring childbirth fear in women (Bergström et al., 2013;Wijma et al., 1998). To apply the scale to fathers, Bergström et al. (2013)  In the study conducted by Li et al. (2009) In the study carried out by Bergstrom et al. (2009), parental stress was measured using the SPSQ. This questionnaire is based on American questionnaire parenting stress index (Östberg et al., 1997). In this study, childbirth expectation and childbirth

| D ISCUSS I ON
The  , 2008). Mismanagement of these issues may discourage fathers from expressing these feelings which, in turn, has its adverse consequences (Chandler & Field, 1997;Eriksson et al., 2007).

Our investigation indicates the most intervention implemented
to reduce anxiety, stress and fear of childbirth was educational trials (Bergström et al., 2009(Bergström et al., , 2013Li et al., 2009), although the results are controversial (Bergström et al., 2009;Hallgreen et al., 1999;Smith, 1999). Given that one of the reasons for poor emotional feelings during pregnancy is the lack of knowledge about pregnancy and childbirth (Hanson et al., 2009;Salehi et al., 2016), so healthcare providers with providing appropriate education can take an important step. These educations could be organized in form of individual or group activities and be taught through classes, reading documents, watching videos, discussing or be Internet-based (Bergström et al., 2013;Stark & Nursing, 1997). The content of the educational courses could be including information about the natural process of childbirth, possible complications, ways to reduce pain and the causes of fear of childbirth. There should also be an opportunity for fathers to discuss their feelings. These educations elevate confidence in fathers by increasing their knowledge and skills that needed to help them to play a more constructive role in childbirth processes (Li et al., 2009).
Our study showed the beneficial effects of music, massage and relaxation on the expectant fathers' anxiety in a few limited trials (Labrague & McEnroe-Petitte, 2016;Latifses et al., 2005). It seems music through the brain affects the noradrenaline, cortisol, endorphins and adrenocorticotropic (McCaffrey et al., 2020;Spintge & Droh, 1987). Music intervention programmes can be recognized as a leading non-invasive cost-effective approach targeting the rising costs of healthcare services worldwide (Browning, 2001;Labrague & McEnroe-Petitte, 2016). Also, massage as a one of the most popular complementary and alternative medical treatments for anxiety (Ardianti et al., 2020;Hall et al., 2020) can improve the expectant fathers' anxiety (Latifses et al., 2005). Learning and practicing massage by fathers makes fathers feel closer to their spouses and their foetuses, reduces pre-natal and postpartum tensions and also increases marital satisfaction and ultimately improves parental relationships.
Relaxation is another intervention that creates a feeling of calm by affecting the autonomic nerves. Nonetheless, Latifses et al. (2005) failed to discover any evidences in support of anxiety-reducing effects of relaxation.
This study can be helpful to obstetricians, midwives, psychologists and psychiatrists in managing anxiety, stress and fear of childbirth in spouses of pregnant women and thus improve the quality of fathers' health and subsequent family health. The strengths of this review include a rigorous literature search, use of a validated methodology and use of two independent reviewers during data evaluation, data extraction and synthesis. There is a possibility of publication bias as only published data were included. Also, some potential limitations need to be acknowledged. Firstly, the methodological quality of the studies varied, which might have affected the results. Given the heterogeneity of the populations enrolled in terms of characteristics and sample sizes, findings should be taken with particular caution. Secondly, differing definitions of anxiety, stress and fear of childbirth in fathers, including different measurement tools and cut-offs, were used so meta-analysis could not be performed.

| CONCLUSION
This systematic review cannot provide any evidence to support the superiority of one intervention over another. Hence, verification of the effectiveness of interventions for the management of anxiety, stress and fear of childbirth demands additional probe and contemplation.

| ACKNOWLEDG EMENT
The current review is part of a master's thesis by Seyedeh Fatemeh Ghaffari, a master's student in midwifery counselling. Hereby, we express our gratitude to the Deputy of Research in Mazandaran University of Medical Sciences.

ACK N OWLED G M ENTS
The current review is part of a master's thesis by Seyedeh Fatemeh

CO N FLI C T O F I NTE R E S T S
The authors have no conflicts of interest relevant to this article.

CO N FLI C T S O F I NTE R E S T
There are no conflicts of interest.

AUTH O R S' CO NTR I B UTI O N S
SF. Ghaffari and Z. Shahhosseini: Designing and conducting the study and manuscript writing; Z. Shahhosseini and F. Elyasi: Editing the final manuscript and providing critical revision; SN.
Mousavinasab: Statistical analyses. All authors: Manuscript reading and approval.

DATA AVA I L A B I L I T Y S TAT E M E N T
Data will be available upon your request.