Mindfulness-Based Childbirth Education for Pregnant Women With Distress

NCT ID: NCT07122115

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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This study was conducted to investigate the effects of a mindfulness-based childbirth and parenting education program on pregnant women who were identified as having prenatal distress. A randomized controlled trial design was used with a pre-test/post-test model. The participants were recruited from Kayseri City Training and Research Hospital's Pregnancy School and Outpatient Clinic between November and December 2022.

A total of 201 pregnant women were screened using the Tilburg Pregnancy Distress Scale (TPDS), and 31 women who scored 28 or higher and met the inclusion criteria were selected. Participants were randomly assigned into two groups: an intervention group (n=16) that received an 8-week mindfulness-based childbirth and parenting education program, and a control group (n=15) that received standard prenatal education.

The mindfulness-based program was conducted online and included guided mindfulness practices, psychoeducation, breathing exercises, and home assignments. Each session lasted approximately 120 minutes and was held once a week for eight consecutive weeks. Participants were also encouraged to practice formal and informal mindfulness exercises at home throughout the program.

The data were collected using several validated instruments, including the Tilburg Pregnancy Distress Scale, Mindful Attention Awareness Scale (MAAS), Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ), Visual Analog Scale (VAS) for labor pain, Maternal Attachment Scale, and Postpartum Self-Evaluation Questionnaire. Data collection occurred at multiple time points: before the intervention, after the intervention, on the first postpartum day, and during the first and fourth postpartum months.

Conditions

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PRENATAL DISTRESS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard Prenatal Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Arm

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

Group Type EXPERIMENTAL

Mindfulness-Based Childbirth and Parenting Education

Intervention Type 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.

Interventions

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Mindfulness-Based Childbirth and Parenting Education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

\-

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kayseri Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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MERVE GÜL TİREN

Specialist Nurse, PhD Candidate, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kayseri City Training and Research Hospital

Kayseri, Kocasi̇nan, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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KayseriTRH-distress

Identifier Type: -

Identifier Source: org_study_id

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