Mindfulness-Based Childbirth Education for Pregnant Women With Distress

NCT07122115 | Completed DMC

• 1 other identifier: KayseriTRH-distress
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aimed to evaluate the effects of a mindfulness-based childbirth and parenting education program on pregnant women experiencing prenatal distress. A total of 31 participants were randomly assigned to either an intervention group, which received an 8-week mindfulness-based education, or a control group, which received standard prenatal care. The study assessed outcomes such as pregnancy-related stress, fear of childbirth, conscious awareness, maternal attachment, and postpartum adaptation.

Conditions

PRENATAL DISTRESS

Keywords

MİNDFULNESS; PRENATAL DİSTRESS; FEAR OF CHILDBİRTH; MATERNAL ATTACHMENT

Outcome Measures

Primary Outcomes (1)

• Change in Prenatal Distress Level

  Measured using the Tilburg Pregnancy Distress Scale (TPDS), which assesses pregnancy-related emotional distress.

  From baseline (pre-intervention) to immediately post-intervention (approximately 8 weeks)

Secondary Outcomes (1)

• Change in Mindful Awareness

  Baseline and post-intervention (8 weeks)

Study Arms (2)

Standard Prenatal Care

NO INTERVENTION

Participants in this group received routine prenatal care and standard childbirth education provided by the hospital without any mindfulness component.

Experimental Arm

EXPERIMENTAL

Participants in this group received an 8-week mindfulness-based childbirth and parenting education program, including guided mindfulness practices, psychoeducation, and home assignments.

Behavioral: Mindfulness-Based Childbirth and Parenting Education

Interventions

Mindfulness-Based Childbirth and Parenting Education BEHAVIORAL

The intervention was an 8-week mindfulness-based childbirth and parenting education program specifically adapted for pregnant women experiencing prenatal distress. The program included weekly 120-minute online sessions combining formal mindfulness practices (such as mindful breathing, body scan, and sitting meditation), informal exercises (e.g., mindful eating, mindful walking), psychoeducation, group sharing, and guided reflections. Participants were also asked to complete daily home practice assignments using audio recordings. The content was adapted from the Mindfulness-Based Childbirth and Parenting (MBCP) curriculum and integrated with prenatal education. The intervention was delivered by a trained instructor and tailored to meet the emotional and cognitive needs of expectant mothers.

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• First-time pregnancy (primigravida)
• Gestational age between 24 and 32 weeks
• No chronic medical or psychiatric conditions
• Able to participate in online sessions
• TPDS (Tilburg Pregnancy Distress Scale) score of 28 or higher
• Minimum literacy level to understand consent and questionnaires
• Voluntary participation and signed informed consent

You may not qualify if:

• High-risk pregnancy (e.g., preeclampsia, placenta previa)
• Multiple pregnancy (e.g., twins or more)
• Existing diagnosis of major psychiatric disorders
• Participation in any previous mindfulness training
• Inability to complete follow-up assessments
• Non-consent or withdrawal from the study

Sponsors & Collaborators

• Kayseri Training and Research Hospital: lead

Study Sites (1)

Kayseri City Training and Research Hospital

Kayseri, Kocasi̇nan, 38080, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Nurse, PhD Candidate, Principal Investigator

Model Details: Participants were randomly assigned to one of two parallel groups: an intervention group receiving mindfulness-based childbirth and parenting education, and a control group receiving standard prenatal care. Each group was followed independently throughout the study period.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 31, 2023
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)