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Comparative Study Between Leg Massage and Vibration on Cramps and Comfort for Patients Undergoing Hemodialysis

NCT07777354 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-08-20

No results posted yet for this study

Summary

This planned randomized controlled trial will enroll 164 patients undergoing hemodialysis to compare the effectiveness of leg massage versus vibration therapy on muscle cramps and patient comfort. Participants will be randomly assigned to one of three groups: a massage group receiving 20-minute lower extremity massage sessions, a vibration group receiving 10-minute vibration therapy, or a control group receiving standard care only. All interventions will be administered three times per week for two weeks (six sessions). The study will evaluate cramp frequency, cramp severity using a Visual Analog Scale, sleep quality through the Pittsburgh Sleep Quality Index, and patient comfort scores. Both interventions are expected to significantly reduce cramp frequency and severity compared to standard care, with massage anticipated to show superior benefits for sleep quality and home-based cramp reduction, while vibration is expected to provide better immediate comfort during dialysis sessions. No serious adverse events are predicted. The findings will help healthcare providers offer personalized, evidence-based non-pharmacological options to improve quality of life for hemodialysis patients.

Conditions

  • Hemodialysis
  • Renal Failure , Chronic

Interventions

OTHER

massage

Received a standardized 20-minute lower extremity massage (effleurage, petrissage, friction, tapotement) during each HD session, 3x/week for 2 weeks (6 sessions), administered by trained nurses (19).

OTHER

vibration

Received 10 minutes of mechanical vibration (30-50 Hz, 2-4 mm amplitude) applied to the calf, tibialis anterior, and quadriceps muscles via a portable device during each HD session (20).

Sponsors & Collaborators

  • University of Baghdad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-10
Primary Completion
2026-12-10
Completion
2026-12-12

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777354 on ClinicalTrials.gov