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

What this trial studies

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 in scope

• Insomnia

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…
• 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.…

Who can join

Women only · Ages 45 Years to 60 Years · Accepts healthy volunteers.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-03-04
• Primary completion: 2025-06-01
• Last update posted: 2025-06-25
• First posted: 2025-06-25

Sponsor & contact

Lead sponsor: Superior University (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• 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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.