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NCT Number: NCT07415122

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Prenatal stress level

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

    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.

Other outcomes

  1. Childbirth self-efficacy

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hatice A Alaftan, MSc

CONTACT

[email protected]

+90 5359456794

Serap Ö Altınayak, Doç. Dr.

CONTACT

[email protected]

+90 5323613394

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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