Combined Effect of Reflexology and GS on Insomnia Vesomotor Symptoms and QOL in Post-menopausal Women

Not Applicable

Active, not recruiting

• Conditions: Insomnia

• Registration Number: NCT07037108
• Lead Sponsor: Superior University

Brief Summary

The purpose of this study is to assess how reflexology and general stretching affect postmenopausal women's quality of life, vasomotor symptoms, and insomnia. Hormonal changes in postmenopausal women frequently result in hot flashes, sleep difficulties, and a general reduction in quality of life. Although non-pharmacological treatments like stretching and reflexology have demonstrated promise in treating these symptoms on their own, little study has evaluated how well they work together.

Detailed Description

Purposive sampling was used to choose postmenopausal women between the ages of 45 and 60 for a randomized controlled experiment. Participants were divided into two groups at random: the group participating in the experiment received generalized stretching exercises and reflexology, whereas the control group only received stretching or routine care. Three sessions a week for six weeks was the duration of the intervention. Standardized instruments such as the Menopause Ratings Scale (MRS) for vasomotor complaints, the severity index for insomnia (ISI), and the menu menopausal particular aspects of life and post-intervention evaluations were used to measure outcomes. The effectiveness of the measures was then compared."

Study Timeline

• Study Start: 2025-03-04
• Status Verified: 2025-06
• Primary Completion: 2025-06-01
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Postmenopausal women aged between 45 and 60 years
• Women experiencing insomnia, vasomotor symptoms (e.g., hot flashes), and reduced quality of life
• Women who are at least 12 months amenorrheic
• Willing to participate and provide informed consent
• Physically able to perform stretching exercises

Exclusion Criteria

• Women on hormone replacement therapy or other medications affecting sleep or menopause symptoms
• History of recent surgery or musculoskeletal injuries preventing physical activity
• Diagnosed psychiatric or neurological disorders
• Severe systemic illnesses (e.g., uncontrolled diabetes, cardiovascular diseases)
• Participation in another clinical trial or intervention in the last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	6 Month	insomnia. Each item is rated from 0 (no problem) to 4 (very severe problem). Total Score Range: 0-28; 0-7: No clinically significant insomnia 8-14: Subthreshold insomnia 15-21: Moderate insomnia 22-28: Severe insomnia
Menopause Rating Scale (MRS)	6 Months	Assesses 11 common menopausal symptoms divided into three subscales: somatic, psychological, and urogenital. Each symptom is rated from 0 (none) to 4 (very severe).; Total Score Range: 0-44 Higher scores indicate more severe symptoms
Menopause-Specific Quality of Life Questionnaire (MENQOL)	6 months	A 29-item self-report scale that measures the impact of menopause on quality of life in four domains: Vasomotor (3 items) Psychosocial (7 items) Physical (16 items) Sexual (3 items) Each item is scored from 0 (not at all bothered) to 6 (extremely bothered). Higher scores indicate greater symptom burden and lower quality of life.

Trial Locations

Locations (1)

Javaid poly clinic; 🇵🇰 Lahore, Pakistan