InsomniaNCT07037108
Combined Effect of Reflexology and GS on Insomnia Vesomotor Symptoms and QOL in Post-menopausal Women
A study testing Reflexology + Generalized Stretching and Stretching Only in people with Insomnia, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Reflexology + Generalized Stretching and Stretching Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effect of Reflexology and General Stretching on Insomnia Vesomotor Symptoms and Quality of Life 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.
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."
- Conditions
- Insomnia
- Being tested
- Reflexology + Generalized Stretching, Stretching Only
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflexology + Generalized StretchingCombination 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 OnlyCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Reflexology + Generalized Stretching | Experimental | Not described Receives: Combination Product: Reflexology + Generalized Stretching |
| Stretching Only | Active comparator | Not described Receives: Combination Product: Stretching Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start4 Mar 2025
- Primary completion1 Jun 2025
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037108
- Sponsor's protocol ID
- DPT/Batch-Fall20/1006
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Reflexology and General Stretching on Insomnia Vesomotor Symptoms and Quality of Life in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT07037108
- Acronym / sponsor ID
- DPT/Batch-Fall20/1006
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reflexology + Generalized Stretching | Experimental | Combination Product: Reflexology + Generalized Stretching |
| Stretching Only | Active comparator | Combination Product: Stretching Only |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reflexology + Generalized StretchingParticipants 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 product | Reflexology + Generalized Stretching |
| Stretching OnlyGeneralized 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. | Combination product | Stretching Only |
Primary outcome
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology + Generalized Stretching and Stretching Only in people with Insomnia, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: 6 Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.