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

Sponsor
Inonu University
Study ID
NCT07402096
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
MALE
Age
45 Years - 60 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Feb 11, 2026
Start date
May 15, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Hot Flash Frequency and Severity [ Time Frame: Baseline and 8 weeks ]

Find similar trials

Nationwide
Menopause trialsWomen's health trialsFertility trials

Related Studies