NCT07293182

Brief Summary

the Objectives of this clinical trial is :

  1. 1.examine the effect of using elastic compression stockings in the prevention of muscle cramps among hemodialysis patients.
  2. 2.Find out the difference between the effect of compression stockings in the prevention of muscle cramps with patients' sociodemographic and clinical data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

December 21, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

December 6, 2025

Last Update Submit

May 15, 2026

Conditions

Keywords

Elastic Compression Stockings, Muscle Cramps, Hemodialysis.

Outcome Measures

Primary Outcomes (2)

  • Cramp Questionnaire Chart

    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

    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).

    Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session

Study Arms (2)

compression stockings group

EXPERIMENTAL

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.

Device: compression stockings

control group

NO INTERVENTION

Patients in the control group received their usual medical care during hemodialysis without any additional interventions.

Interventions

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.

compression stockings group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imam AL-Hassan AL-Mujtaba Teaching Hospital

Karbala, Karbala Governorate, Iraq

Location

Imam Al-Hussein Medical City (Habib Ibn Mudaher Al-Asadi center)

Karbala, Karbala Governorate, Iraq

Location

MeSH Terms

Conditions

Muscle Cramp

Interventions

Stockings, Compression

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Compression BandagesBandagesEquipment and Supplies

Study Officials

  • zahraa A Kareem, MGS

    kerbala heath department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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 HD session. This was performed once per day for a single HD session. While Patients in the control group received their usual medical care during HD without any additional interventions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's graduate student

Study Record Dates

First Submitted

December 6, 2025

First Posted

December 19, 2025

Study Start

December 21, 2025

Primary Completion

April 15, 2026

Study Completion

April 15, 2026

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations