CClinicalTrials.gg
CompletedNCT07122115Updated Aug 14, 2025

Mindfulness-Based Childbirth Education for Pregnant Women With Distress

An interventional study of Mindfulness-Based Childbirth and Parenting Education in PRENATAL DISTRESS, sponsored by Kayseri Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by Kayseri Training and Research Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Nov 2022, registered Aug 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • PRENATAL DISTRESS

Keywords

  • MİNDFULNESS
  • PRENATAL DİSTRESS
  • FEAR OF CHILDBİRTH
  • MATERNAL ATTACHMENT
03

In context

Lead sponsor

Kayseri Training and Research Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • No intervention
    Standard Prenatal Care

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

  • Experimental
    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.

    Behavioral: Mindfulness-Based Childbirth and Parenting Education

Interventions

  • BehavioralMindfulness-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.

06

What researchers measure

Primary outcomes

  1. Change in Prenatal Distress Level

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

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

Secondary outcomes

  1. Change in Mindful Awareness

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

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

07

Study locations

1 site
  • Kayseri City Training and Research Hospital
    Kayseri, Kocasi̇nan 38080, Turkey (Türkiye)
08

References and documents

Study documents

  • Study protocol · Jul 30, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared due to ethical concerns regarding participant privacy, as well as institutional restrictions on data sharing without explicit participant consent.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07122115
Lead sponsor
Kayseri Training and Research Hospital
Responsible party
MERVE GÜL TİREN (Specialist Nurse, PhD Candidate, Principal Investigator, Kayseri Training and Research Hospital) — Principal investigator
First posted
Aug 14, 2025
Start date
Nov 1, 2022
Primary completion
Apr 30, 2023
Completion
May 31, 2023
Last update
Aug 14, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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