'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, Esther I. de Bruin, Nancy Bardacke, Larissa G Duncan, Francisca J A Van Steensel, Carmen D Dirksen, Susan M. Bögels
BMC Psychiatry November 7, 2016 DOI: 10.1186/s12888-016-1070-8 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Quasi-experimental controlled trial Peer reviewed |
|---|---|
| Sample size | 128 |
| Population | Pregnant women at 16-26 weeks gestation with a high level of Fear of Childbirth (W-DEQ-A score ≥66), and their partners |
| Intervention | Mindfulness-Based Childbirth and Parenting (MBCP) |
| Duration | Six months with four assessment waves: pre- and post-intervention, following the birth and closing the maternity leave period |
| Measures | Wijma Delivery Expectancy Questionnaire (W-DEQ-A) |
| Topics | Meditation |
| Keywords | Humans Pregnancy complications Pregnancy outcome Prenatal care Delivery, obstetric Stress, psychological Self efficacy Mothers Postpartum period Parturition Quality of life Female Obstetric labor complications Young adult Surveys and questionnaires Pregnant people Cost-effectiveness Labour pain Obstetrical interventions Fear of childbirth |
| Key findings | The authors propose a theoretical model of Avoidance and Participation in Pregnancy, Birth and the Postpartum Period to explore Fear of Childbirth and to evaluate the mechanisms of change of Mindfulness-Based Childbirth and Parenting. They argue that MBCP may be effective in decreasing pregnancy-related anxiety and stress, and that this trial can be important if statistically and clinically meaningful benefits are found. |
Abstract
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/design: 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.
Discussion: 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.
Trial Registration: Dutch Trial Register (NTR): NTR4302 , registration date the 3rd of December 2013.
Comparable studies
Other non-randomized and open-label trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Mindfulness-Based Stress Reduction in Relation to Quality of Life, Mood, Symptoms of Stress, and Immune Parameters in Breast and Prostate Cancer Outpatients Early-stage breast and prostate cancer patients | 2003 | Pre-post intervention study | n = 59 |
| Exploring self‐compassion and empathy in the context of mindfulness‐based stress reduction (MBSR) Community sample | 2010 | Pre-post intervention study | |
| Mindfulness-Based Stress Reduction Lowers Psychological Distress In Medical Students Second-year medical students | 2003 | Prospective nonrandomized cohort-controlled study | n = 302 |
| Intensive meditation training, immune cell telomerase activity, and psychological mediators. Retreat participants and matched controls | 2011 | Controlled trial with wait-list control group | n = 60 |
| The Effectiveness of Mindfulness Training for Children with ADHD and Mindful Parenting for their Parents Children aged 8-12 with ADHD and their parents | 2011 | Within-group waitlist controlled trial | n = 22 |
Citations in the library
Cited by 5
- The effects of the Mindfulness-Based Childbirth and Parenting Program (MBCP) on prenatal attachment, depression, stress, and anxiety in pregnant women: A randomized controlled trial. Journal of Affective Disorders May 1, 2025
- Reconnecting with the Self and Fetus through Mindfulness: Supporting Inner Balance and Bonding during Pregnancy Psikiyatride Güncel Yaklaşımlar April 14, 2026
- Examining the Occurrence and Clinical Impact of Difficult Experiences that Emerge during a Mindfulness-Based Intervention among Individuals at High-Risk of Suicide. Mindfulness June 18, 2024
- Mindful with your baby for mothers of infants with (parental) stress in a non-clinical setting: a wait-list controlled pilot trial. BMC Pregnancy and Childbirth April 7, 2022
- A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial. Trials November 28, 2019
Cites 7
- Mindfulness training as a clinical intervention: A conceptual and empirical review. Clinical Psychology Science and Practice 2003
- Mindfulness-Based Cognitive Therapy for Depression: A New Approach to Preventing Relapse Psychotherapy Research March 1, 2003
- CALM Pregnancy: results of a pilot study of mindfulness-based cognitive therapy for perinatal anxiety. Archives of women's mental health January 22, 2014
- Randomised controlled pilot trial of mindfulness training for stress reduction during pregnancy. Psychology and Health November 1, 2013
- Do mindfulness-based interventions reduce pain intensity? A critical review of the literature. Pain Medicine February 2013
and 2 more in the library