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Completed

NCT Number: NCT07122115

Mindfulness-Based Childbirth Education for Pregnant Women With Distress

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri City Training and Research Hospital

Kayseri, Kocasi̇nan, 38080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Female participants aged 18 to 35

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Prenatal Distress Level

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

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

Secondary outcomes

  1. Change in Mindful Awareness

    Time frame: Baseline and post-intervention (8 weeks)

    Measured using the Mindful Attention Awareness Scale (MAAS). Higher scores indicate greater mindfulness.

Sponsors and collaborators

Lead sponsor

Kayseri Training and Research Hospital

Other Gov

Registry information

Official study title

The Effect of Mindfulness-Based Childbirth and Parenting Education on Birth Parameters and Postpartum Adaptation in Pregnant Women With Distress

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

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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