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

February 3, 2026 updated by: Kader ATABEY, Inonu University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a randomized controlled trial with a pretest-posttest control group design to evaluate the effects of an 8-week Mindfulness-Based Stress Reduction (MBSR) program on menopausal symptoms. The study population consists of menopausal women aged 45-60 years who report experiencing hot flashes and poor sleep quality.

Participants will be recruited from gynecology outpatient clinics and randomly assigned to either the intervention group or the control group. The intervention group will participate in an 8-week standardized MBSR program consisting of weekly sessions lasting 60-90 minutes. The program includes mindfulness practices such as breathing awareness, body awareness, emotional regulation, stress response awareness, and mindfulness in daily life. Sessions will be delivered through a combination of face-to-face and online formats. The control group will not receive any intervention during the study period.

Outcome measures will be assessed at baseline and at the end of the 8-week intervention period. Primary outcome measures include hot flash frequency and severity and sleep quality, assessed using validated instruments. Secondary outcomes include mindfulness levels and perceived symptom-related distress. Data will be analyzed using appropriate statistical methods to compare within-group and between-group changes. Ethical approval has been obtained, and written informed consent will be obtained from all participants prior to enrollment.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • - Women aged between 45 and 60 years
  • Postmenopausal status defined as at least 12 months since the last menstrual period
  • Presence of hot flashes
  • Poor sleep quality (Pittsburgh Sleep Quality Index score >5)
  • Ability to understand and complete questionnaires
  • Access to the internet and ability to use a smartphone or computer for online sessions
  • Willingness to participate and provide written informed consent

Exclusion Criteria:

  • Current use of hormone replacement therapy

    • Use of psychiatric medications
    • Diagnosis of a psychiatric disorder
    • Severe hearing or visual impairment
    • Previous participation in mindfulness-based or yoga programs
    • Incomplete baseline assessments
    • Failure to attend intervention sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Based Stress Reduction (MBSR) Group
Participants in this arm will receive an 8-week Mindfulness-Based Stress Reduction (MBSR) program. The program consists of weekly sessions lasting 60-90 minutes and includes mindfulness practices such as breathing awareness, body scan, emotional awareness, stress response awareness, and mindfulness in daily life. Sessions will be delivered through a combination of face-to-face and online formats.
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.
No Intervention: Control Group
Participants in this arm will receive no intervention during the study period and will continue with their usual care. They will complete the same outcome assessments as the intervention group at baseline and at the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hot Flash Frequency and Severity
Time Frame: Baseline and 8 weeks
Change from baseline to 8 weeks in hot flash frequency and severity, assessed using a validated hot flash diary or hot flash rating scale. Higher scores indicate greater symptom severity.
Baseline and 8 weeks
Change in Sleep Quality
Time Frame: Baseline and 8 weeks
Change in sleep quality from baseline to 8 weeks, assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INU-MBSR-MEN-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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