Mindfulness-Based Intervention in Primiparous Pregnant Women (MBCP)

June 16, 2026 updated by: Ebru SOLMAZ, Agri Ibrahim Cecen University

Effect of a Mindfulness-Based Intervention on Childbirth Self-Efficacy, Fear of Childbirth, and Self-Compassion in Primiparous Pregnant Women: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effect of a mindfulness-based intervention on childbirth self-efficacy, fear of childbirth, and self-compassion among primiparous pregnant women. Eligible pregnant women will be randomly assigned to either a mindfulness intervention group or a control group receiving routine antenatal education and standard prenatal care. The intervention program will consist of eight sessions delivered over four weeks. Outcomes will be assessed before and after the intervention using validated measurement tools. The findings may contribute to the development of effective psychosocial interventions to improve maternal well-being during pregnancy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pregnancy is a period characterized by significant physical, psychological, and social changes. Fear of childbirth, low childbirth self-efficacy, and difficulties in self-compassion may negatively affect maternal well-being and childbirth experiences. Mindfulness-based interventions have been increasingly used to support psychological health during pregnancy; however, evidence regarding their effects on childbirth self-efficacy, fear of childbirth, and self-compassion remains limited.

This study is designed as a randomized controlled trial to evaluate the effectiveness of a mindfulness-based intervention among primiparous pregnant women attending a pregnancy school affiliated with a Healthy Life Center in Ağrı, Türkiye. A total of 128 eligible pregnant women will be randomly assigned to either an intervention group or a control group.

Participants in the intervention group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion, and mindfulness-based coping strategies for childbirth preparation. Participants in the control group will continue to receive routine antenatal education and standard prenatal care.

Data will be collected before and after the intervention using validated instruments assessing childbirth self-efficacy, fear of childbirth, and self-compassion. The results of this study may provide evidence for the integration of mindfulness-based approaches into antenatal care programs to enhance maternal psychological well-being and preparedness for childbirth.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women aged 18 years and older
  • Primiparous women
  • Singleton pregnancy
  • Gestational age between 28 and 32 weeks
  • No known obstetric complications
  • Ability to read and understand Turkish
  • Attendance at the Pregnancy School of the Healthy Life Center
  • Willingness to participate and provide written informed consent
  • Willingness to participate in the mindfulness-based intervention program

Exclusion Criteria:

  • Multiple pregnancy
  • High-risk obstetric complications (e.g., preeclampsia, gestational diabetes, placenta previa)
  • Diagnosed severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder)
  • Substance or alcohol dependence
  • Previous participation in a structured mindfulness, meditation, or similar awareness-based program
  • Inability to attend intervention sessions regularly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Based Intervention Group
Participants in this group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, self-compassion, and mindfulness-based coping strategies for childbirth preparation.
Behavioral: Mindfulness-Based Intervention
A four-week mindfulness-based intervention consisting of eight sessions delivered twice weekly. The program includes breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion practices, and mindfulness-based coping strategies for childbirth preparation. Sessions will be delivered face-to-face and will last approximately 60-90 minutes each.
No Intervention: Routine Antenatal Care Group
Participants will receive routine antenatal education and standard prenatal care. No mindfulness-based intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childbirth Self-Efficacy
Time Frame: Baseline and 4 weeks after intervention
Assessment of childbirth self-efficacy using the Childbirth Self-Efficacy Scale.
Baseline and 4 weeks after intervention
Fear of Childbirth
Time Frame: Baseline and 4 weeks after intervention
Assessment of fear of childbirth using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A).
Baseline and 4 weeks after intervention
Self-Compassion
Time Frame: Baseline and 4 weeks after intervention
Assessment of self-compassion using the Self-Compassion Scale.
Baseline and 4 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agri Ibrahim Cecen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PMI-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly available in order to protect participant confidentiality and privacy. Only de-identified aggregate study results will be reported.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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