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Effect of a Mindfulness-Based Stress Reduction Program on Hot Flashes and Sleep Quality in Menopausal Women: A Randomized Controlled Trial

NCT07402096 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-02-11

No results posted yet for this study

Summary

Menopause is a natural transition characterized by vasomotor symptoms such as hot flashes and sleep disturbances, which can significantly impair quality of life. Non-pharmacological interventions are increasingly recommended for women who cannot or prefer not to use hormone therapy. Mindfulness-Based Stress Reduction (MBSR) is a structured behavioral intervention that has shown beneficial effects on stress-related symptoms and sleep quality; however, evidence regarding its effects on menopausal symptoms remains limited.

This randomized controlled trial aims to evaluate the effectiveness of an 8-week MBSR program on hot flash frequency and severity and sleep quality in menopausal women. A total of 90 menopausal women will be randomly assigned to either an intervention group receiving the MBSR program or a control group receiving no intervention. Participants in the intervention group will attend weekly sessions and engage in mindfulness practices, including breathing awareness, body scan, and stress management techniques.

Primary outcomes include changes in hot flash frequency and severity and sleep quality, assessed using validated self-report measures. The findings of this study are expected to contribute to evidence-based, non-pharmacological management strategies for menopausal symptoms.

Conditions

Interventions

BEHAVIORAL

Mindfulness-Based Stress Reduction (MBSR)

Mindfulness-Based Stress Reduction (MBSR) is a structured behavioral intervention consisting of an 8-week program with weekly sessions lasting 60-90 minutes. The program includes mindfulness practices such as breathing awareness, body scan, emotional awareness, stress response awareness, and mindfulness in daily life. Sessions are delivered through a combination of face-to-face and online formats.

Sponsors & Collaborators

  • Inonu University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2026-09-30
Completion
2026-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07402096 on ClinicalTrials.gov