MBSR for Premenstrual Syndrome and Childbirth Fear

NCT07360197 | Completed

• 1 other identifier: INONU-CT-4615-MBSR
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluates the effectiveness of a Mindfulness-Based Stress Reduction (MBSR) program on premenstrual symptom severity, fear of childbirth, and psychological well-being in women experiencing Premenstrual Syndrome (PMS). PMS is a prevalent condition characterized by emotional, cognitive, and physical symptoms that significantly impair women's daily functioning, stress tolerance, and quality of life. In addition to its somatic and affective burden, PMS is associated with increased anxiety and emotional dysregulation, which may contribute to elevated fear related to pregnancy and childbirth during the preconception period. A total of 126 women aged 18 years and older who met the diagnostic threshold for PMS (Premenstrual Syndrome Scale score ≥ 110) were enrolled between June 2023 and November 2025 and randomly assigned in a 1:1 ratio to either an MBSR intervention group or a control group. The intervention group received an eight-session online MBSR program delivered twice weekly, with each session lasting 40 minutes. The program included mindfulness-based practices such as body scan, breath awareness, emotion-focused mindfulness, and cognitive awareness exercises, supported by structured home practice assignments. The control group received no active intervention during the study period. Primary and secondary outcomes were assessed using validated self-report instruments at baseline and after completion of the 8-week intervention period. Premenstrual symptom severity was measured using the Premenstrual Syndrome Scale (PMSS), fear of childbirth was evaluated with the Childbirth Fear-Prior to Pregnancy Scale (CF-PPS), and psychological well-being was assessed using the Psychological Well-Being Scale (PWBS). The primary objective of the study is to determine whether participation in the MBSR program leads to a greater reduction in premenstrual symptom severity compared to a control condition. Secondary objectives include evaluating the effect of MBSR on reducing fear of childbirth and improving psychological well-being. This study aims to provide evidence for the effectiveness of a non-pharmacological, mindfulness-based intervention in supporting women's mental and reproductive health during the premenstrual period.

Conditions

Premenstrual Syndrome; Fear of Childbirth; Psychological Well-being

Keywords

Mindfulness-Based Stress Reduction; MBSR; Premenstrual Syndrome; Childbirth Fear; Psychological Well-being; Women's Mental Health; Behavioral Intervention; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Premenstrual Syndrome Severity

  Change in total score of the Premenstrual Syndrome Scale (PMSS) from baseline to post-intervention at 8 weeks.

  Baseline to 8 weeks

Secondary Outcomes (2)

• Fear of Childbirth

  Baseline to 8 weeks

• Psychological Well-being

  Baseline to 8 weeks

Study Arms (2)

MBSR Intervention Group

EXPERIMENTAL

articipants in this arm received an 8-session Mindfulness-Based Stress Reduction (MBSR) program delivered online. Each session lasted 40 minutes and was conducted twice weekly. The program included mindfulness practices such as body scan, breath awareness, emotional awareness, and mindfulness-based coping strategies, along with home practice assignments.

Behavioral: MBSR Intervention Group

Control Group

NO INTERVENTION

Participants in this arm did not receive any active intervention during the study period. They completed baseline and post-intervention assessments only and were provided with an information booklet after completion of the study.

Interventions

MBSR Intervention Group BEHAVIORAL

A structured 8-session mindfulness-based stress reduction program designed to enhance awareness, emotion regulation, and stress coping. The intervention included guided mindfulness practices such as body scan, breathing exercises, emotional awareness, and cognitive mindfulness strategies delivered online by a certified instructor.

MBSR Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged 18 years or older
• Regular menstrual cycles (21-35 days)
• Premenstrual Syndrome Scale (PMSS) total score ≥110
• Willingness to participate and provide informed consent

You may not qualify if:

• Presence of any gynecological disorder (e.g., abnormal uterine bleeding, fibroids, ovarian cysts)
• Use of hormonal contraceptives or contraceptive pills
• Failure to attend more than two MBSR sessions

Sponsors & Collaborators

• Aysel AKBENIZ: lead

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome; Psychological Well-Being

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychiatric Nursing

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 22, 2026
• Study Start: June 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)