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

NCT07415122 | Not Yet Recruiting

• 1 other identifier: OMU-MIDWIFERY-MBCE-RCT-2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Prenatal Stress; Childbirth Self-efficacy; Fear of Childbirth

Keywords

Mindfulness; Childbirth Preparation Education; Pregnancy; Midwifery; Randomized Controlled Trial; Maternal Mental Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Prenatal stress level

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

Other Outcomes (1)

• Childbirth self-efficacy

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

Study Arms (2)

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.

Behavioral: Mindfulness-based childbirth preparation education

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.

Behavioral: Mindfulness-based childbirth preparation education

Interventions

Mindfulness-based childbirth preparation education BEHAVIORAL

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.

Mindfulness-Based Childbirth Preparation; Standard Childbirth Preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Samsun City Hospital

Samsun, 55139, Turkey (Türkiye)

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Hatice A Alaftan, MSc

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

• Serap ö Altınayak, Doç. Dr.

  Ondokuz Mayıs University

  STUDY DIRECTOR

• SERAP Ö Altınayak, Assoc. Prof.

  Ondokuz Mayıs University

  STUDY DIRECTOR

Central Study Contacts

Hatice A Alaftan, MSc

CONTACT

+90 5359456794; hmbb0308@gmail.com

Serap Ö Altınayak, Doç. Dr.

CONTACT

+90 5323613394; serap.ozturk@omu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Midwifery, Ondokuz Mayıs University

Model Details: Participants will be randomly assigned to one of two parallel groups: an intervention group or a control group. Both groups will be followed simultaneously throughout the study period. The intervention group will receive childbirth preparation education that includes mindfulness practices, while the control group will receive standard childbirth preparation education without mindfulness components. Outcomes will be measured at baseline and after the intervention, and results will be compared between groups.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 17, 2026
• Study Start: February 1, 2026
• Primary Completion: April 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)