'I've Changed My Mind', Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial.

Irena K Veringa,Larissa G Duncan,Francisca J A Van Steensel,Carmen D Dirksen,Nancy Bardacke,Esther I De Bruin,Susan M Bögels

doi:10.1186/s12888-016-1070-8

Abstract

BackgroundApproximately 25 % of pregnant women suffer from a high level of Fear of Childbirth (FoC), as assessed by the Wijma Delivery Expectancy Questionnaire (W-DEQ-A, score ≥66). FoC negatively affects pregnant women’s mental health and adaptation to the perinatal period. Mindfulness-Based Childbirth and Parenting (MBCP) seems to be potentially effective in decreasing pregnancy-related anxiety and stress. We propose a theoretical model of Avoidance and Participation in Pregnancy, Birth and the Postpartum Period in order to explore FoC and to evaluate the underlying mechanisms of change of MBCP.Methods/DesignThe ‘I’ve Changed My Mind’ study is a quasi-experimental controlled trial among 128 pregnant women (week 16–26) with a high level of FoC, and their partners. Women will be allocated to MBCP (intervention group) or to Fear of Childbirth Consultation (FoCC; comparison group). Primary outcomes are FoC, labour pain, and willingness to accept obstetrical interventions. Secondary outcomes are anxiety, depression, general stress, parental stress, quality of life, sleep quality, fatigue, satisfaction with childbirth, birth outcome, breastfeeding self-efficacy and cost-effectiveness. The total study duration for women is six months with four assessment waves: pre- and post-intervention, following the birth and closing the maternity leave period.DiscussionGiven the high prevalence and severe negative impact of FoC this study can be of major importance if statistically and clinically meaningful benefits are found. Among the strengths of this study are the clinical-based experimental design, the extensive cognitive-emotional and behavioural measurements in pregnant women and their partners during the entire perinatal period, and the representativeness of study sample as well as generalizability of the study’s results. The complex and innovative measurements of FoC in this study are an important strength in clinical research on FoC not only in pregnant women but also in their partners.Trial registrationDutch Trial Register (NTR): NTR4302, registration date the 3rd of December 2013.

Highlights

25 % of pregnant women suffer from a high level of Fear of Childbirth (FoC), as assessed by the Wijma Delivery Expectancy Questionnaire (W-DEQ-A, score ≥66)
Given the high prevalence and severe negative impact of FoC this study can be of major importance if statistically and clinically meaningful benefits are found
The complex and innovative measurements of FoC in this study are an important strength in clinical research on FoC in pregnant women and in their partners

Summary

Discussion

This will be the first RCT comparing the effects of MBCP to FoCC on an array of childbirth and early parenting outcomes in pregnant women with a high level of FoC and their partners. Addressing the problem of FoC is critical and the proposed study evaluates an innovative MBCP that holds the potential of being an effective, non-invasive, and non-medical intervention for pregnant women with FoC, whit the potential for widespread dissemination that builds on the popularity of MBP’s. We expect a potentially stronger effect of MBCP than FoCC on adaptation to the perinatal period, and a decrease in not-urgent medical interventions during childbirth. The quasi-experimental study design creates less homogeneous groups with full randomization (RCT) and permits a greater risk of bias due to potential alternation and allocation problems.

Background

Methods

Findings