About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
- 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)
Disqualifiers
Current use of hormone replacement therapy
Use of psychiatric medications
Diagnosis of a psychiatric disorder
Severe hearing or visual impairment
Trial design
Parallel
Treatments tested in this trial
Mindfulness-Based Stress Reduction (MBSR)
BehavioralMindfulness-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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Hot Flash Frequency and Severity
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
Change in sleep quality from baseline to 8 weeks, assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.
Locations
Sponsors and contacts
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