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

NCT07037108 | Active Not Recruiting DMC

• 1 other identifier: DPT/Batch-Fall20/1006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (3)

• Insomnia Severity Index (ISI)

  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

  6 Month

• Menopause Rating Scale (MRS)

  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

  6 Months

• Menopause-Specific Quality of Life Questionnaire (MENQOL)

  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.

  6 months

Study Arms (2)

Reflexology + Generalized Stretching

EXPERIMENTAL

Combination Product: Reflexology + Generalized Stretching

Stretching Only

ACTIVE COMPARATOR

Combination Product: Stretching Only

Interventions

Reflexology + Generalized Stretching COMBINATION_PRODUCT

Participants in Group 1 received a combination of foot reflexology and generalized stretching exercises. focusing on specific reflex points related to the endocrine, nervous, and reproductive systems. Each reflexology session lasted for 20 minutes, conducted three times per week for 6 weeks.

Reflexology + Generalized Stretching

Stretching Only COMBINATION_PRODUCT

Generalized Stretching Only Method: Generalized Stretching Exercises Details: Participants in Group 2 received only generalized stretching exercises without any reflexology treatment. The stretching protocol included exercises for major muscle groups such as the neck, shoulders, back, hips, hamstrings, and calves. Each session will last for 20-25 minutes, which included a 5-minute warm-up, 15-20 minutes of static stretching, and a 5-minute cool-down.

Stretching Only

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Javaid poly clinic

Lahore, Pakistan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: March 4, 2025
• Primary Completion: June 1, 2025
• Study Completion: September 30, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)