'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.
BACKGROUND
Approximately 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
The '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.


CONCLUSIONS
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. 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.


BACKGROUND
Dutch Trial Register (NTR): NTR4302 , registration date the 3rd of December 2013.
Research Institute Child Development and Education (RICDE), Faculty of Social and Behavioral Sciences, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 127, 1018 WS, Amsterdam, The Netherlands. I.K.Veringa@uva.nl.
Irena K
IK
Veringa
Research Institute Child Development and Education (RICDE), Faculty of Social and Behavioral Sciences, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 127, 1018 WS, Amsterdam, The Netherlands.|UvA minds, academic outpatient child and adolescent treatment center of the University of Amsterdam, Plantage Muidergracht 14, 1018 TV, Amsterdam, The Netherlands.
Esther I
EI
de Bruin
Osher Center for Integrative Medicine and Department of Nurse-Midwifery, University of California-San Francisco (UCSF), UCSF box 1726, San Francisco, CA, 94143-1726, USA.
Nancy
N
Bardacke
Department of Human Development and Family Studies and Department of Family Medicine and Community Health, University of Wisconsin-Madison, Madison, WI, 53706, USA.
Larissa G
LG
Duncan
Research Institute Child Development and Education (RICDE), Faculty of Social and Behavioral Sciences, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 127, 1018 WS, Amsterdam, The Netherlands.|UvA minds, academic outpatient child and adolescent treatment center of the University of Amsterdam, Plantage Muidergracht 14, 1018 TV, Amsterdam, The Netherlands.
Francisca J A
FJ
van Steensel
Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht University Medical Center, P. Debyelaan 25, 6202 AZ, Maastricht, The Netherlands.
Carmen D
CD
Dirksen
Research Institute Child Development and Education (RICDE), Faculty of Social and Behavioral Sciences, Research Priority Area Yield, University of Amsterdam, Nieuwe Achtergracht 127, 1018 WS, Amsterdam, The Netherlands.|UvA minds, academic outpatient child and adolescent treatment center of the University of Amsterdam, Plantage Muidergracht 14, 1018 TV, Amsterdam, The Netherlands.
Susan M
SM
Bögels
D000328:Adult; D036861:Delivery, Obstetric / Q000523:psychology; D005239:Fear; D005260:Female; D006801:Humans; D064866:Mindfulness; D009035:Mothers / Q000523:psychology; D007744:Obstetric Labor Complications / Q000523:psychology*; D036801:Parturition / Q000523:psychology*; D010353:Patient Education as Topic / Q000379:methods*; D049590:Postpartum Period / Q000523:psychology; D011247:Pregnancy; D011248:Pregnancy Complications / Q000523:psychology; D011256:Pregnancy Outcome / Q000523:psychology; D037841:Pregnant People / Q000523:psychology; D011295:Prenatal Care / Q000379:methods*; D011788:Quality of Life; D020377:Self Efficacy; D013315:Stress, Psychological / Q000523:psychology; D011795:Surveys and Questionnaires; D055815:Young Adult
Cost-effectiveness; Fear of childbirth; Labour pain; Mindfulness; Obstetrical interventions