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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.
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.
Age
45 - 60 years
Sex
MALE
Healthy Volunteers
Yes
Start Date
May 15, 2026
Primary Completion Date
September 1, 2026
Completion Date
December 1, 2026
Last Updated
February 11, 2026
90
ESTIMATED participants
Mindfulness-Based Stress Reduction (MBSR)
BEHAVIORAL
Lead Sponsor
Inonu University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06691178