NCT07018765

Brief Summary

This randomized controlled trial aims to evaluate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on birth memory and perception of traumatic birth among women who have undergone vaginal delivery. The study will be conducted between July and October 2025 at Malatya Training and Research Hospital. Participants in the intervention group will attend an 8-week MBSR program, while the control group will receive no intervention. Data will be collected using validated scales before and after the intervention. The primary outcomes are changes in birth memory and traumatic birth perception scores.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

June 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

June 4, 2025

Last Update Submit

April 6, 2026

Conditions

Keywords

MindfulnessPostpartum StressMaternal Mental HealthMidwifery

Outcome Measures

Primary Outcomes (1)

  • Change in Birth Memory Score

    Assessed by the Birth Memory and Recall Scale. Measures the quality and nature of the memory related to the childbirth experience.Assessed by the Birth Memory and Recall Scale (range 6-147). Higher scores indicate more vivid, intense, and emotionally charged birth memories. Items are rated on a 7-point Likert scale. Items 1, 3, and 11 are reverse scored.

    Baseline and 8 weeks post-intervention

Secondary Outcomes (1)

  • Change in Perception of Traumatic Birth

    Baseline and 8 weeks post-intervention

Other Outcomes (1)

  • Change in Mindfulness Level

    Baseline and 8 weeks post-intervention

Study Arms (2)

MBSR Group

EXPERIMENTAL

Participants in this group will receive an 8-week Mindfulness-Based Stress Reduction (MBSR) program, including weekly 60-90 minute sessions covering mindful breathing, body awareness, emotion regulation, and stress management. The first session will be face-to-face, and subsequent sessions will be delivered online (Zoom).

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Control Group

NO INTERVENTION

Participants in this group will receive routine postpartum care and no additional intervention.

Interventions

The MBSR program consists of eight weekly sessions, each lasting 60-90 minutes. The first session will be delivered face-to-face in the hospital, and the remaining sessions will be conducted online via Zoom. The program content includes mindful breathing, body scanning, stress management, emotional regulation, and interpersonal mindfulness exercises.

MBSR Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women who have undergone a vaginal birth
  • Literate and able to understand Turkish
  • No diagnosed psychiatric disorder
  • Have access to internet and a smart device (for online MBSR sessions)

You may not qualify if:

  • History of pregnancy loss, stillbirth, or neonatal death
  • Complications during postpartum period in mother or newborn
  • Incomplete data collection or failure to attend MBSR sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Education and Research Hospital

Malatya, Leave Blank, 440000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Birth Injuries

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm randomized controlled trial (MBSR vs. control)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Research, Faculty of Health Sciences, Inonu University

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 12, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations