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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fear of Childbirth; Prenatal Stress; Childbirth Self-efficacy
• Intervention / Treatment: Behavioral: Mindfulness-based childbirth preparation education

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hatice A Alaftan, MSc; Phone Number: +90 5359456794; Email: hmbb0308@gmail.com
• Study Contact Backup: Name: Serap Ö Altınayak, Doç. Dr.; Phone Number: +90 5323613394; Email: serap.ozturk@omu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Samsun, Turkey (Türkiye), 55139
    • Samsun City Hospital
    • Contact: Hatice A Alaftan, MSc; Email: hmbb0308@gmail.com
    • Contact: Serap ö Altınayak, Doc.Dr.; Phone Number: +905323613394; Email: serap.ozturk@omu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Childbirth Preparation; 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.	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-efficacy.
Active Comparator: Standard Childbirth Preparation; 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.	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-efficacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth fear level	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.	From baseline (28-34 weeks of gestation) to post-intervention (36-38 weeks of gestation).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prenatal stress level	Stress during pregnancy will be assessed by administering the Prenatal Stress Questionnaire (PSQ) to pregnant women between the 28th and 38th weeks of pregnancy. High scores on the scale indicate that pregnant women perceive high levels of stress before delivery. Changes from baseline to post-intervention will be compared between the mindfulness-based childbirth education group and the standard childbirth education group. Scores on the scale and each subscale range from 1 to 5 points. An increase in the total score indicates an increase in the stress level perceived by pregnant women. The total Cronbach's alpha coefficient for the scale is 0.70.	From baseline (28-34 weeks of gestation) to post-intervention (36-38 weeks of gestation).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childbirth self-efficacy	Birth self-efficacy will be measured among pregnant women between the 28th and 38th weeks of pregnancy using the Birth Self-Efficacy Scale. Changes from baseline to post-intervention will be analyzed between the awareness-based childbirth education group and the standard childbirth education group. The Self-Efficacy Scale for Childbirth has two subscales: expectation of outcome and expectation of efficacy. Each subscale consists of 16 questions. Scores for each subscale range from 16 to 160. The total possible score for both subscales ranges from 32 to 320. High scores on the scale indicate that pregnant women have high confidence in themselves and a strong belief in their ability to succeed during childbirth. The Cronbach's alpha coefficient for the scale was found to be 0.90.	From baseline (28-34 weeks of gestation) to post-intervention (36-38 weeks of gestation).

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Investigators: Principal Investigator: Hatice A Alaftan, MSc, Ondokuz Mayıs University; Study Director: Serap ö Altınayak, Doç. Dr., Ondokuz Mayıs University; Study Director: SERAP Ö Altınayak, Assoc. Prof., Ondokuz Mayıs University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Mindfulness; Randomized Controlled Trial; Midwifery; Maternal Mental Health; Childbirth Preparation Education
• Other Study ID Numbers: OMU-MIDWIFERY-MBCE-RCT-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Some individual participant data may not be shared to protect participant privacy and confidentiality, in accordance with ethical approvals. Only de-identified data will be available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No