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NCT Number: NCT07037108

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Javaid poly clinic

Lahore, Pakistan

About this study

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."

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: 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

  2. Menopause Rating Scale (MRS)

    Time frame: 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

  3. Menopause-Specific Quality of Life Questionnaire (MENQOL)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Combined Effect of Reflexology and General Stretching on Insomnia Vesomotor Symptoms and Quality of Life in Post-menopausal Women

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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