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

NCT07402096 | Not Yet Recruiting

• 1 other identifier: INU-MBSR-MEN-2025
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Menopause; Hot Flashes; Sleep Wake Disorders

Keywords

Menopause; Hot Flashes; Non-pharmacological intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 8 weeks

• 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.

  Baseline and 8 weeks

Study Arms (2)

Mindfulness-Based Stress Reduction (MBSR) Group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

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.

Interventions

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.

Mindfulness-Based Stress Reduction (MBSR) Group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

MeSH Terms

Conditions

Hot Flashes; Sleep Wake Disorders

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kader ATABEY

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: February 11, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02