- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07683494
Kinesiotape Versus Compression Stockings on Pregnant Leg Cramps and Sleep Quality
June 27, 2026 updated by: Noha fathy abdelhamid khalifa, Kafrelsheikh University
Effect of Kinesiotape Versus Compression Stockings on Leg Cramps and Sleep Quality in Pregnant Women :A Randomized Controlled Trial
Kinesiotape versus compression stockings on pregnant leg cramps and sleep quality
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Effect of kinesiotape versus compression stockings on leg cramps and sleep quality in pregnant women A Randomized controlled trial
Study Type
Interventional
Enrollment (Estimated)
60
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 Contact
- Name: Noha Fathy Khalifa, Bachelor
- Phone Number: 0201558281224
- Email: nohapt44@gmail.com
Study Locations
-
-
Elgharbia
-
Samannoud, Elgharbia, Egypt
- Elnasria medical centre
-
Contact:
- Noha Fathy Khalifa, Bachelor
- Phone Number: 021558281224
- Email: nohapt44@gmail.com
-
Samanonud, Elgharbia, Egypt
- Elnasria medical centre
-
Contact:
- Noha Fathy Khalifa, Bachelor
- Phone Number: 0201558281224
- Email: nohapt44@gmail.com
-
-
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
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- -Pregnant female suffering from calf cramps. 2-Their ages range from 25to 35 years. 3-Their body mass index ranges from 25 to 29.9kg/m2. 4-Pregnant female in the second or third trimester.
Exclusion Criteria:
- Skin abnormalities [malignancy or burn in the treated area]. 2-History of previous back surgery. 3-Present of any neuromuscular disease [like multiple sclerosis]. 4-Sensory disturbances. 5-Evidence of previous vertebral fractures or spinal structural abnormalities. 6-Women who have eclampsia or pre-eclampsia. 7-History of edema, thrombosis, venous thrombosis.
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 |
|---|---|
|
Active Comparator: Control
Control group receive instructions about dealing with leg cramps at bedtime
|
Receive instructions about dealing with leg cramps at bedtime as sustained stretch,massage and optimal sleeping position
|
|
Experimental: Kinesiotape group
Application of kinesiology tape to the lower leg muscles for 48 hours, applied twice a week for 4 weeks, in addition to standard instructions for managing leg cramps at bedtime
|
Receive instructions about dealing with leg cramps at bedtime as sustained stretch,massage and optimal sleeping position
Application of kinesiology tape to the lower leg muscles for 48 hours, applied twice a week for 4 weeks, in addition to standard instructions for managing leg cramps at bedtime
|
|
Experimental: Compression stockings group
Use of graduated compression stockings worn daily for a period of 4 weeks, in addition to standard instructions for managing leg cramps at bedtime.
|
Receive instructions about dealing with leg cramps at bedtime as sustained stretch,massage and optimal sleeping position
Use of graduated compression stockings worn daily for a period of 4 weeks, in addition to standard instructions for managing leg cramps at bedtime.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle cramp characteristics measured using The Cramp Questionnaire
Time Frame: Baseline and after4weeks
|
Change in leg cramp frequency assessed using the Leg Cramp Questionnaire.
Higher scores indicate greater cramp frequency.
|
Baseline and after4weeks
|
|
Leg cramp pain intensty measured using visual analogue scale
Time Frame: Baseline and after4weeks
|
Pain intensity using visual analogue scale 0=no pain,10=wirst pain
|
Baseline and after4weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality measured using sleep quality index
Time Frame: Baseline and after4weeks
|
Sleep quality assesed using the Pittsburgh sleep quality index score range 0-21 higher score means poor sleep quality
|
Baseline and after4weeks
|
|
Quality of life measured using 12-item short form health survey
Time Frame: Baseline and after4weeks
|
Health related quality of life assesed using the SF-12questionnaire.higher
score indicates better health status
|
Baseline and after4weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Noha Fathy khalifa, Bachelor, Faculty of physical therapy kafrelsheikh university
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 (Estimated)
July 1, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
June 19, 2026
First Submitted That Met QC Criteria
June 27, 2026
First Posted (Actual)
July 6, 2026
Study Record Updates
Last Update Posted (Actual)
July 6, 2026
Last Update Submitted That Met QC Criteria
June 27, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-1065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participants data will not be shared
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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