NCT07360197

MBSR for Premenstrual Syndrome and Childbirth Fear

Completed NA Last updated 26 January 2026

What this trial tests

NA trial testing MBSR Intervention Group in Premenstrual Syndrome in 126 participants. Completed in 1 November 2025.

Timeline

1 June 2023

Primary endpoint
1 November 2025

1 November 2025

Quick facts

Lead sponsor	Aysel AKBENIZ
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	1 June 2023
Primary completion	1 November 2025
Estimated completion	1 November 2025
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• MBSR Intervention Group

Conditions studied

• Premenstrual Syndrome — all drugs for Premenstrual Syndrome →
• Fear of Childbirth — all drugs for Fear of Childbirth →
• Psychological Well-being — all drugs for Psychological Well-being →

Sponsor

Aysel AKBENIZ

Who can join

18 and older, female only, with Premenstrual Syndrome or Fear of Childbirth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.