Clinical trial NCT07018765: Effect of Mindfulness-Based Stress Reduction on Birth Memory and Perception of Traumatic Birth
Official title: The Effect of Mindfulness-Based Stress Reduction Program on Birth Memory and Perception of Traumatic Birth: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpartum Psychological Stress
Mindfulness-Based Stress Reduction
Maternal Health
Traumatic Birth
Keywords: Mindfulness
Postpartum Stress
Maternal Mental Health
Midwifery
Lead sponsor: Inonu University
Sponsor class: OTHER
Collaborators: name: Malatya Egitim Ve Arastirma Hastanesi
First posted: 2025-06-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized controlled trial (MBSR vs. control)
Primary purpose: TREATMENT

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.

Detailed description: This study is a pretest-posttest control group experimental design conducted to determine the effects of a Mindfulness-Based Stress Reduction (MBSR) program on birth memory and the perception of traumatic birth. The population of the study will consist of women who have had a vaginal delivery and received postpartum care at Malatya Training and Research Hospital between July and October 2025. The sample will include 80 women, with 40 in the experimental group and 40 in the control group. The intervention group will participate in an 8-week MBSR program, which includes weekly 60-90 minute sessions-first face-to-face and the rest conducted online. The program content will cover mindful breathing, body awareness, stress and emotion regulation, and interpersonal mindfulness.

Data will be collected using the Mindfulness Scale, the Birth Memory and Recall Scale, and the Traumatic Birth Perception Scale. Pre-test data will be collected during the initial hospital visit, and post-test data will be collected at the end of the 8-week program. No intervention will be applied to the control group. Statistical analyses will include descriptive statistics, independent samples t-tests, and paired samples t-tests. Ethical approval has been applied for and informed consent will be obtained from all participants.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Birth Memory Score
timeFrame: Baseline and 8 weeks post-intervention
Secondary outcomes:
measure: Change in Perception of Traumatic Birth
timeFrame: Baseline and 8 weeks post-intervention
Other outcomes:
measure: Change in Mindfulness Level
timeFrame: Baseline and 8 weeks post-intervention
Locations:
city: Malatya
country: Turkey
facility: Malatya Education and Research Hospital
state: Leave Blank
Study officials:
References: