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Not yet recruiting NCT07415122

The Effect of Mindfulness-Based Childbirth Education on Fear of Birth, Prenatal Stress, and Childbirth Self-Efficacy

No phase Interventional Prenatal Stress Childbirth Self-efficacy Fear of Childbirth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness-based childbirth preparation education.
Who it may be relevant to
Registry conditions: Prenatal Stress, Childbirth Self-efficacy, Fear of Childbirth. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This randomized controlled trial aims to evaluate the effect of mindfulness practices integrated into childbirth preparation education on fear of childbirth, prenatal stress, and childbirth self-efficacy in pregnant women.Participants will be randomly assigned either to the childbirth education group with mindfulness practices or to the standard childbirth education/control group. Results will be evaluated using the prenatal self-assessment childbirth fear subscale, the perceived stress scale before childbirth, and the self-efficacy scale during labor before and after intervention.This study aims to provide evidence on whether mindfulness practices in childbirth preparation classes affect pregnant women's fear of childbirth, prenatal stress, and childbirth self-efficacy.

Detailed description

Pregnancy is a period during which women experience significant physiological, psychological, and social changes. One of the most common psychosocial problems encountered during this period is fear of childbirth and prenatal stress, both of which can negatively affect maternal well-being. The literature shows that high levels of fear of childbirth and prenatal stress are associated with increased rates of intervention during childbirth, prolonged labor, low birth satisfaction, breastfeeding problems, and an increased risk of postpartum anxiety/depression. In contrast, it has been reported that pregnant women with high birth self-efficacy approach the birth process more positively, experience less stress, and have more positive birth experiences.

In recent years, mindfulness-based approaches have emerged as effective interventions for stress management, emotion regulation, and increasing psychological resilience. Mindfulness practices enable individuals to focus on the present moment without judgment, become aware of their bodily sensations, and approach stress-inducing thoughts in a more flexible manner. While evidence is growing that mindfulness-based interventions during pregnancy reduce anxiety and stress levels, studies in which these practices are systematically integrated into childbirth preparation education and tested in a controlled manner are limited.

This randomized controlled trial aims to evaluate the effect of mindfulness practices added to childbirth preparation education on pregnant women's fear of childbirth, prenatal stress, and childbirth self-efficacy. The study will be conducted at the Samsun City Hospital Maternity School. A total of 80 pregnant women will be included in the study, and participants will be randomly assigned to two groups: (1) an experimental group receiving mindfulness-based childbirth preparation education and (2) a control group receiving standard childbirth preparation education.

Both groups will participate in a two-week childbirth preparation education program consisting of a total of four sessions. In addition to the standard content, the experimental group will be taught mindfulness exercises based on breath awareness, body awareness, focus of attention, and coping with stress, and participants will be given homework for daily practice. The control group will only receive routine maternity school education, without any mindfulness content.

The data collection process will be conducted in two stages: pretest (before training) and posttest (after training). Prenatal stress levels will be measured using the Prenatal Stress Scale, fear of childbirth will be measured using the fear of childbirth subscale of the Prenatal Self-Assessment Scale, and childbirth self-efficacy will be measured using the Childbirth Self-Efficacy Scale.

This study is expected to contribute scientifically to the development of prenatal care programs by revealing the effects of integrating mindfulness practices into childbirth preparation education on the psychological health of pregnant women. It also aims to provide guidance to healthcare professionals and pregnant women by demonstrating the applicability and effectiveness of mindful awareness techniques during the preparation for childbirth process.

Interventions

  • Behavioral Mindfulness-based childbirth preparation education
    This intervention consists of a structured childbirth preparation education program that integrates mindfulness practices into routine antenatal education. The program includes breathing exercises, body awareness activities, mindful relaxation, and guided meditation. The intervention is delivered in group sessions by a trained midwife, with four sessions conducted over a two-week period. The content is designed to reduce fear of childbirth, decrease prenatal stress, and enhance childbirth self-e

Primary outcome measures

  • Birth fear level [Time frame: From baseline (28-34 weeks of gestation) to post-intervention (36-38 weeks of gestation).]
Secondary outcome measures (1)
  • Prenatal stress level [Time frame: From baseline (28-34 weeks of gestation) to post-intervention (36-38 weeks of gestation).]

Eligibility criteria

Inclusion criteria

  • Pregnant women aged 18 years or older
  • Gestational age between 28 and 38 weeks
  • Primiparous (first pregnancy)
  • Able to understand and speak Turkish
  • No communication problems that would hinder participation
  • No high-risk pregnancy as determined by a physician
  • Able to read and write
  • Willing to participate in the study and providing informed consent

Exclusion criteria

  • • Pregnant women with high-risk pregnancies (history of antepartum bleeding, intrauterine growth restriction, placenta previa, membrane rupture, preeclampsia, hypertension, diabetes, or other medical conditions, fetal anomalies, or any contraindication to normal vaginal delivery, substance or alcohol dependence)
  • pregnant women with a diagnosed psychiatric illness or who have undergone psychotherapy or medication treatment in the last six months,
  • pregnant women who have previously participated in childbirth preparation classes,
  • pregnant women with experience in yoga and meditation before or during pregnancy,
  • pregnant women with chronic illnesses,
  • pregnant women who are foreign nationals.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Samsun City Hospital — Samsun

Publications

  • Duncan LG, Cohn MA, Chao MT, Cook JG, Riccobono J, Bardacke N. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison. BMC Pregnancy Childbirth. 2017 May 12;17(1):140. doi: 10.1186/s12884-017-1319-3. PMID 28499376
  • Byrne J, Hauck Y, Fisher C, Bayes S, Schutze R. Effectiveness of a Mindfulness-Based Childbirth Education pilot study on maternal self-efficacy and fear of childbirth. J Midwifery Womens Health. 2014 Mar-Apr;59(2):192-7. doi: 10.1111/jmwh.12075. Epub 2013 Dec 10. PMID 24325752
  • Dinc S, Erdogan E, Dogan RA. The effect of mindfulness-based childbirth education intervention on fear of childbirth: systematic review and meta-analysis. Rev Assoc Med Bras (1992). 2024 Aug 16;70(7):e20240167. doi: 10.1590/1806-9282.20240167. eCollection 2024. PMID 39166664

Identifiers

NCT: NCT07415122 · OMU-MIDWIFERY-MBCE-RCT-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗