Effects of Reflexology and Generalized Stretching in Postmenopausal Females.

December 20, 2024 updated by: Riphah International University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 05499
        • Akhtar Saeed trust hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REFLEXOLOGY
Other: REFLEXOLOGY
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.
Active Comparator: GENERALIZED STRETCHING
Other: GENERALIZED STRETCHING
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3rd week
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.
3rd week
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.
3rd week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: hina gul, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Actual)

August 10, 2024

Study Completion (Actual)

August 19, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REC/RCR&AHS/23/0576

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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