Prenatal StressNCT07415122
The Effect of Mindfulness-Based Childbirth Education on Fear of Birth, Prenatal Stress, and Childbirth Self-Efficacy
A study testing Mindfulness-based childbirth preparation education in people with Prenatal Stress and Childbirth Self-efficacy, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Stress, Childbirth Self-efficacy, Fear of Childbirth
- What is being tested?
- Mindfulness-based childbirth preparation education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 15 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Samsun City Hospital
Samsun, 55139
Hatice A Alaftan, MSc, hmbb0308@gmail.com
Serap ö Altınayak, Doc.Dr., +905323613394, serap.ozturk@omu.edu.tr
About this study
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.
Read the 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.
- Being tested
- Mindfulness-based childbirth preparation education
- Keywords
- Mindfulness, Childbirth Preparation Education, Pregnancy, Midwifery, Randomized Controlled Trial, Maternal Mental Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based childbirth preparation educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness-based childbirth preparation education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (28-34 weeks of gestation) to post-intervention (36-38 weeks of gestation).
Secondary outcomes (1)
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.
Measured: From baseline (28-34 weeks of gestation) to post-intervention (36-38 weeks of gestation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prenatal StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Ozturk Altinayak, Ondokuz Mayıs University
- Investigators
- Hatice A Alaftan, MSc, Principal investigator, Ondokuz Mayıs UniversitySerap ö Altınayak, Doç. Dr., Study director, Ondokuz Mayıs UniversitySERAP Ö Altınayak, Assoc. Prof., Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415122
- Sponsor's protocol ID
- OMU-MIDWIFERY-MBCE-RCT-2025
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 28499376Byrne 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.
PubMed 24325752Dinc 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.
PubMed 39166664