Postmenopausal DisorderNCT06303297
Effects of Reflexology and Generalized Stretching in Postmenopausal Females.
A study testing REFLEXOLOGY and GENERALIZED STRETCHING in people with Postmenopausal Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the combined Effects of reflexology and generalized stretching on insomnia, vasomotor symptoms and quality of life in postmenopausal females Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Disorder
- What is being tested?
- REFLEXOLOGY and GENERALIZED STRETCHING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Nov 2023to 19 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI less than 30 kg/m2
- Residents of rural areas
- Stable vital signs
- Participants with natural cessation of menstrual periods for at least 12 months
- Moderate and severe hot flash
Who cannot join
- Participants with history of hysterectomy surgical menopause females
- Participants with orthopedic disorder
- Participants taking sleeping pills
- Women suffer from pathological conditions for example cardiac disease, cancer impaired skin integrity
- Participants with history of recent bone fracture
- Severe pathology(eczema) of feet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects of Reflexology and Generalized Stretching on Insomnia, Vasomotor Symptoms and Quality of Life in Postmenopausal Females
To determine the combined Effects of reflexology and generalized stretching on insomnia, vasomotor symptoms and quality of life in postmenopausal females
- Conditions
- Postmenopausal Disorder
- Being tested
- REFLEXOLOGY, GENERALIZED STRETCHING
- Keywords
- Female, insomnia, postmenopausal, quality of life, reflexology
- 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.
REFLEXOLOGYOther
will receive foot and hand reflexology and stretching. The researcher will administer foot and hand reflexology to the participant for a period of 3 weeks this last for a duration of 10 min on each hand and foot with total duration of 40 minutes. Foot reflexology include general foot massage, including the foot rotation, Achilles stretching, and the foot extension and stretching, will be performed for a minute on each foot. In the right foot, the bottom of the heel will be kept with the left hand, and the metatarsal arch of the same foot will be held with the other hand. Then, the foot will be rotated clockwise and counter clockwise three times each direction. The same technique will be performed on the left foot. On hand lubricated with moisturizer to the dorsal and plantar surface and apply pressure on for 10 minutes. Noninvasive and safe complementary therapy that involves a direct pressure on specific body points connecting specific organs.
GENERALIZED STRETCHINGOther
will receive Stretching of upper and lower limbs. The stretching program lasts for 3 weeks with 60 min of stretching session 3 times a week. Extension of body include shoulder extension, torso rotation, hip extension, calf stretching (ankle pumps). ten stretches of 30 s each, with 15 s of rest between each stretch
| Study group | Role | What they receive |
|---|---|---|
| REFLEXOLOGY | Experimental | Not described Receives: Other: REFLEXOLOGY |
| GENERALIZED STRETCHING | Active comparator | Not described Receives: Other: GENERALIZED STRETCHING |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity index score
This questionnaire is a 7 items questionnaire which is used to assess sleep problems. It scoring is done through Likert type scale ranging from 0 to 4, where higher score represents higher sleep problem. Its score is range from 0 to 28 where 0 to 7 shows no clinically significant insomnia, 8 to 14 shows subthreshold insomnia, 15 to 21 shows moderate severity of insomnia and 22 to 28 shows severe severity of insomnia. It is a reliable and valid tool with internal consistency of 0.74 and correlation ranging from 0.36 to 0.54.
Measured: 3rd week
Menopause Rating Scale
Menopause Rating Scale is a 11 items questionnaire which is use to assess vasomotor symptoms like hot flush, palpitations, sleep problem, bladder symptoms and other symptoms.
Its score range is from 0 to 4, where 0 shows no complain and 4 shows severe symptoms. Its total score range is from 9 to 21, where higher the score higher are the symptoms. It has good validity and reliability. It has Cronbach alpha value of 0.86 and internal consistency of 0.81.
Measured: 3rd week
Menopause Specific Quality of Life
Menopause specific quality of life (MENQOL) questionnaire is a 29 items questionnaire which is used to assess quality of life among menopausal women. It has further four domains vasomotor (item 1 to 3), sexual (item 27-29), psychosocial (item 4-10) and physical (item 11 to 26). It is a reliable and valid tool with Cronbach value of 0.70 and internal consistency of 0.45.
Measured: 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start23 Nov 2023
- Primary completion10 Aug 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303297
- Sponsor's protocol ID
- REC/RCR&AHS/23/0576
- Status last verified
- Dec 2024
- First submitted
- 4 Mar 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vogazianou A. Anatomy and physiology of the female reproductive system. Advanced Practice in Endocrinology Nursing. 2019:739-52.
Hoare BS, Mikes BA, Khan YS. Anatomy, Abdomen and Pelvis: Female Internal Genitals. 2025 Feb 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554601/
PubMed 32119488Sochocka M, Karska J, Pszczolowska M, Ochnik M, Fulek M, Fulek K, Kurpas D, Chojdak-Lukasiewicz J, Rosner-Tenerowicz A, Leszek J. Cognitive Decline in Early and Premature Menopause. Int J Mol Sci. 2023 Mar 31;24(7):6566. doi: 10.3390/ijms24076566.
PubMed 37047549Talaulikar V. Menopause transition: Physiology and symptoms. Best Pract Res Clin Obstet Gynaecol. 2022 May;81:3-7. doi: 10.1016/j.bpobgyn.2022.03.003. Epub 2022 Mar 16.
PubMed 35382992Yeo JH, Kim MT. Association of weight, smoking, and alcohol consumption with age at natural menopause. J Women Aging. 2023 Jul-Aug;35(4):343-353. doi: 10.1080/08952841.2022.2050157. Epub 2022 Mar 21.
PubMed 35312401Kalhan M, Singhania K, Choudhary P, Verma S, Kaushal P, Singh T. Prevalence of Menopausal Symptoms and its Effect on Quality of Life among Rural Middle Aged Women (40-60 Years) of Haryana, India. Int J Appl Basic Med Res. 2020 Jul-Sep;10(3):183-188. doi: 10.4103/ijabmr.IJABMR_428_19. Epub 2020 Jul 11.
PubMed 33088741Ragasudha A, Minnu S, Kumar RS. Menopause Induced Depression, Anxiety, Quality of Life, Lack of Sleep in Women: An Overview. Journal of Drug Delivery and Therapeutics. 2021;11(6):319-23.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Reflexology and Generalized Stretching on Insomnia, Vasomotor Symptoms and Quality of Life in Postmenopausal Females
- ClinicalTrials.gov ID
- NCT06303297
- Acronym / sponsor ID
- REC/RCR&AHS/23/0576
- Conditions
- Postmenopausal Disorder
- Keywords
- Female, insomnia, postmenopausal, quality of life, reflexology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 12 Mar 2024 (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.
To determine the combined Effects of reflexology and generalized stretching on insomnia, vasomotor symptoms and quality of life in postmenopausal females
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REFLEXOLOGY | Experimental | Other: REFLEXOLOGY |
| GENERALIZED STRETCHING | Active comparator | Other: GENERALIZED STRETCHING |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI less than 30 kg/m2
- Residents of rural areas
- Stable vital signs
- Participants with natural cessation of menstrual periods for at least 12 months
- Moderate and severe hot flash
Key exclusion criteria (6 listed)
- Participants with history of hysterectomy surgical menopause females
- Participants with orthopedic disorder
- Participants taking sleeping pills
- Women suffer from pathological conditions for example cardiac disease, cancer impaired skin integrity
- Participants with history of recent bone fracture
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 |
|---|---|---|
| REFLEXOLOGYwill receive foot and hand reflexology and stretching. The researcher will administer foot and hand reflexology to the participant for a period of 3 weeks this last for a duration of 10 min on each hand and foot with total duration of 40 minutes. Foot reflexology include general foot massage, including the foot rotation, Achilles stretching, and the foot extension and stretching, will be performed for a minute on each foot. In the right foot, the bottom of the heel will be kept with the left hand, and the metatarsal arch of the same foot will be held with the other hand. Then, the foot will be rotated clockwise and counter clockwise three times each direction. The same technique will be performed on the left foot. On hand lubricated with moisturizer to the dorsal and plantar surface and apply pressure on for 10 minutes. Noninvasive and safe complementary therapy that involves a direct pressure on specific body points connecting specific organs. | Other | REFLEXOLOGY |
| GENERALIZED STRETCHINGwill receive Stretching of upper and lower limbs. The stretching program lasts for 3 weeks with 60 min of stretching session 3 times a week. Extension of body include shoulder extension, torso rotation, hip extension, calf stretching (ankle pumps). ten stretches of 30 s each, with 15 s of rest between each stretch | Other | GENERALIZED STRETCHING |
Primary outcome
Insomnia severity index score
Time frame: 3rd week
This questionnaire is a 7 items questionnaire which is used to assess sleep problems. It scoring is done through Likert type scale ranging from 0 to 4, where higher score represents higher sleep problem. Its score is range from 0 to 28 where 0 to 7 shows no clinically significant insomnia, 8 to 14 shows subthreshold insomnia, 15 to 21 shows moderate severity of insomnia and 22 to 28 shows severe severity of insomnia. It is a reliable and valid tool with internal consistency of 0.74 and correlation ranging from 0.36 to 0.54.
Menopause Rating Scale
Time frame: 3rd week
Menopause Rating Scale is a 11 items questionnaire which is use to assess vasomotor symptoms like hot flush, palpitations, sleep problem, bladder symptoms and other symptoms. Its score range is from 0 to 4, where 0 shows no complain and 4 shows severe symptoms. Its total score range is from 9 to 21, where higher the score higher are the symptoms. It has good validity and reliability. It has Cronbach alpha value of 0.86 and internal consistency of 0.81.
Menopause Specific Quality of Life
Time frame: 3rd week
Menopause specific quality of life (MENQOL) questionnaire is a 29 items questionnaire which is used to assess quality of life among menopausal women. It has further four domains vasomotor (item 1 to 3), sexual (item 27-29), psychosocial (item 4-10) and physical (item 11 to 26). It is a reliable and valid tool with Cronbach value of 0.70 and internal consistency of 0.45.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- BackgroundVogazianou A. Anatomy and physiology of the female reproductive system. Advanced Practice in Endocrinology Nursing. 2019:739-52.
- Background: PubMed 32119488Hoare BS, Mikes BA, Khan YS. Anatomy, Abdomen and Pelvis: Female Internal Genitals. 2025 Feb 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554601/
- Background: PubMed 37047549Sochocka M, Karska J, Pszczolowska M, Ochnik M, Fulek M, Fulek K, Kurpas D, Chojdak-Lukasiewicz J, Rosner-Tenerowicz A, Leszek J. Cognitive Decline in Early and Premature Menopause. Int J Mol Sci. 2023 Mar 31;24(7):6566. doi: 10.3390/ijms24076566.
- Background: PubMed 35382992Talaulikar V. Menopause transition: Physiology and symptoms. Best Pract Res Clin Obstet Gynaecol. 2022 May;81:3-7. doi: 10.1016/j.bpobgyn.2022.03.003. Epub 2022 Mar 16.
- Background: PubMed 35312401Yeo JH, Kim MT. Association of weight, smoking, and alcohol consumption with age at natural menopause. J Women Aging. 2023 Jul-Aug;35(4):343-353. doi: 10.1080/08952841.2022.2050157. Epub 2022 Mar 21.
- Background: PubMed 33088741Kalhan M, Singhania K, Choudhary P, Verma S, Kaushal P, Singh T. Prevalence of Menopausal Symptoms and its Effect on Quality of Life among Rural Middle Aged Women (40-60 Years) of Haryana, India. Int J Appl Basic Med Res. 2020 Jul-Sep;10(3):183-188. doi: 10.4103/ijabmr.IJABMR_428_19. Epub 2020 Jul 11.
- BackgroundRagasudha A, Minnu S, Kumar RS. Menopause Induced Depression, Anxiety, Quality of Life, Lack of Sleep in Women: An Overview. Journal of Drug Delivery and Therapeutics. 2021;11(6):319-23.
- 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.
hina gul principal investigator
Riphah International University
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 and GENERALIZED STRETCHING in people with Postmenopausal Disorder, run by Riphah International 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 6 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: finished, as of the sponsor's last update on 27 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 score (time frame: 3rd week). 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?
On the ClinicalTrials.gov record for NCT06303297, which also lists 7 linked publications.
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 27 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.