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Active, not recruitingNCT07037108Updated Jun 25, 2025

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

An interventional study of Reflexology + Generalized Stretching and Stretching Only in Insomnia, sponsored by Superior University. Active, not recruiting at 1 site in Pakistan. Open to female participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-25.

Sponsored by Superior University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2025, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
45 Years to 60 Years
Sex
Female
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Study 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.

Read the 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."

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Conditions studied

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In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 40 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Superior University is the lead sponsor of 242 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Reflexology + Generalized Stretching

    Combination Product: Reflexology + Generalized Stretching

  • Active comparator
    Stretching Only

    Combination Product: Stretching Only

Interventions

  • Combination productReflexology + Generalized Stretching

    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.

  • Combination productStretching Only

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 Month

  2. 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

    Time frame: 6 Months

  3. 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.

    Time frame: 6 months

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Study locations

1 site
  • Javaid poly clinic
    Lahore, Pakistan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07037108
Lead sponsor
Superior University
Responsible party
Muhammad Naveed Babur (Principal Investigator, Superior University) — Principal investigator
First posted
Jun 25, 2025
Start date
Mar 4, 2025
Primary completion
Jun 1, 2025
Completion
Sep 30, 2025 (estimated)
Last update
Jun 25, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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