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Clinical Trials/NCT07415122
NCT07415122Not yet recruitingNot Applicable

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

Ondokuz Mayıs University1 site in 1 country80 target enrollmentStarted: February 1, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Birth fear level

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

No additional parties were masked in this study. The trial was conducted as an open-label study due to the nature of the educational intervention.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Mindfulness-Based Childbirth Preparation

Experimental

Participants in this arm will receive a structured childbirth preparation education program incorporating mindfulness practices, including breathing exercises, body awareness, mindful relaxation, and guided meditation. The intervention will be delivered in a group format by a trained midwife through four sessions over a two-week period.

Intervention: Mindfulness-based childbirth preparation education (Behavioral)

Standard Childbirth Preparation

Active Comparator

Participants in this arm will receive standard childbirth preparation education without mindfulness practices. The program will be delivered in a group format by a trained midwife through four sessions over a two-week period, matching the duration of the intervention arm.

Intervention: Mindfulness-based childbirth preparation education (Behavioral)

Outcomes

Primary Outcomes

Birth fear level

Time Frame: From baseline (28-34 weeks of gestation) to post-intervention (36-38 weeks of gestation).

Birth fear will be assessed using the Prenatal Self-Assessment Questionnaire Birth Fear Subscale. Changes in birth fear scores from baseline to post-intervention will be compared between the mindfulness-based childbirth education group and the standard childbirth education group. The Prenatal Self-Assessment Scale determines women's adaptation to pregnancy and motherhood. The Prenatal Self-Assessment Scale is a 4-point Likert-type scale with 7 subscales and 79 items. The Childbirth Fear Subscale of the Prenatal Self-Assessment Scale can be used independently. The overall Cronbach's alpha value for the Prenatal Self-Assessment Scale is 0.81. The Fear of Childbirth Subscale consists of ten items. Scores on the scale range from 10 to 40. The Cronbach's alpha value for the Fear of Childbirth Subscale is 0.84. Lower scores on the scale indicate a decrease in the level of fear of childbirth, while higher scores indicate an increase in the level of fear of childbirth.

Secondary Outcomes

  • Prenatal stress level(From baseline (28-34 weeks of gestation) to post-intervention (36-38 weeks of gestation).)

Investigators

Sponsor
Ondokuz Mayıs University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Serap Ozturk Altinayak

Associate Professor, Department of Midwifery, Ondokuz Mayıs University

Ondokuz Mayıs University

Study Sites (1)

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