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

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.

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Key information

Conditions

Menopause Hot Flashes Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

45 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Stress Reduction (MBSR)

Behavioral

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.

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Acronym: MBSR-MENO

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 11, 2026
Registry last updated: Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed