- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07293182
Compression Stockings for Prevention of Hemodialysis Muscle Cramps
May 15, 2026 updated by: Zahraa Adel Kareem, Karbala University
The Role of Using Elastic Compression Stockings in the Prevention of Muscles Cramps Episode in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
the Objectives of this clinical trial is :
- examine the effect of using elastic compression stockings in the prevention of muscle cramps among hemodialysis patients.
- Find out the difference between the effect of compression stockings in the prevention of muscle cramps with patients' sociodemographic and clinical data.
Study Overview
Detailed Description
Intradialytic muscles cramps are frequent complication, and common cause of early hemodialysis (HD) termination.
These cramps are thought to be precipitated by intradialytic venous stasis and reduced tissue perfusion.
Elastic compression stockings (ECS), compress the calf and thigh to counteract venous pooling, and increase venous return.
Study Type
Interventional
Enrollment (Actual)
82
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
-
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Karbala Governorate
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Karbala, Karbala Governorate, Iraq
- Imam AL-Hassan AL-Mujtaba Teaching Hospital
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Karbala, Karbala Governorate, Iraq
- Imam Al-Hussein Medical City (Habib Ibn Mudaher Al-Asadi center)
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-
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
No
Description
Inclusion Criteria:
- Those who are at least eighteen years old.
- Both genders (male & female).
- Patients who are conscious and cooperative.
- Patients experiencing muscle cramps during previous hemodialysis session.
- Patients who would like to participate in part in the study .
- Patients with verbally communicated skills.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: compression stockings group
Patients in the Compression stockings group firmly wrapped compression stockings around their calves for 30 minutes, starting at the end of the second hour and continuing until the beginning of the third hour of the hemodialysis session.
This was performed once per day for a single hemodialysis session.
|
Patients in the Compression stockings group firmly wrapped compression stockings around their calves for 30 minutes, starting at the end of the second hour and continuing until the beginning of the third hour of the hemodialysis session.
This was performed once per day for a single hemodialysis session.
|
|
No Intervention: control group
Patients in the control group received their usual medical care during hemodialysis without any additional interventions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cramp Questionnaire Chart
Time Frame: Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session
|
The instrument was developed by Morris (2014), and permission was obtained from the author.
It was used in the study to assess patients' muscle cramps.
This scale is composed of five features of muscle cramps: frequency, duration, pain level, leg temperature, and discomfort.
These features are comprehensively scored as a level of muscle cramps ranging from 0 to 13.
|
Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session
|
|
Visual analogue scale (VAS) for pain
Time Frame: Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session
|
The Visual Analogue Scale (VAS) is a validated, subjective scale for acute and chronic pain.
It was initially introduced by Hayes and Patterson in 1921.
Scoring involved self-reported symptom scales that are scored with a single handwritten mark placed at a single point along a 10 cm line representing continuity between the two ends of the scale - "no pain" at the left end (0 cm) of the scale and "worst pain" at the right end of the scale (10 cm).
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Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: zahraa A Kareem, MGS, kerbala heath department
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)
December 21, 2025
Primary Completion (Actual)
April 15, 2026
Study Completion (Actual)
April 15, 2026
Study Registration Dates
First Submitted
December 6, 2025
First Submitted That Met QC Criteria
December 6, 2025
First Posted (Actual)
December 19, 2025
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 15, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOK.CON.25.091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data cannot be shared publicly due to ethical and confidentiality restrictions as specified in the informed consent form and approved by the Institutional Review Board.
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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