The Effect of the Massage on Cramp Frequency, Cramp Severity, and Sleep Quality

Not Applicable

Completed

• Conditions: Muscular Cramps; Hemodialysis
• Interventions: Behavioral: intradialytic massage

• Registration Number: NCT04990661
• Lead Sponsor: Kafkas University

Brief Summary

The aim of this randomized controlled experimental study was to determine the effect of the massage applied to hemodialysis patients with complaint of cramp on the cramp frequency, cramp severity, and sleep quality.

Detailed Description

The study was conducted with patients receiving treatment in a total of four hemodialysis units. The sample of the study comprised a total of 36 patients (18 patients in the intervention group and 18 patients in the control group) with complaint of cramp. In the study, intradialytic massage for lower extremity was applied to the intervention group in three sessions a week and a total of six sessions for two weeks. No intervention other than routine care was applied to the control group patients.

In the study, the data were collected using a patient information form, cramp assessment short survey, the "Visual Analog Scale (VAS)", "Pittsburgh Sleep Quality Index" (PUKİ), and patient follow-up forms.

In order to conduct the study, the necessary Ethics Committee approval and institutional permission were obtained. The individuals included in the study informed about the purpose of the research, their verbal consent obtained and the participant's informed consent form signed.

After the intervention and control groups were assigned according to the research criteria, the days and sessions of the groups were determined and recorded in the digital randomization environment.

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-21
• Status Verified: 2021-07
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-27
• Last Update Submitted: 2021-07-27
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 18 years,
• One or more lower work cramp attacks during/after dialysis
• Have a constant dryness in the last 1 month (few changes weighing more than 2 kg)
• Receiving at least 6 hemodialysis treatments
• Receiving hemodialysis treatment 3 times a week
• Those who have not received sub-massage therapy before

Read More

Exclusion Criteria

• Having one of the diagnoses of chronic obstructive pulmonary disease, cancer, psychiatric disease
• Presence of any soft tissue, nerve and vascular disease in the lower extremities
• Presence of infection, open wound, suspected fracture, dermatitis, burn and edema in the lower extremities
• Having had a lower extremity operation in the past six weeks
• Receiving hemodialysis treatment for less than 6 months (new patients are excluded because the first few months of dialysis treatment are periods of hemodynamic instability)
• Having a fluctuating dry weight (excluded from the study as it may cause cramping)
• Having been diagnosed with neuropathy in the lower extremities

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group (massage group)	intradialytic massage	intradialytic massage for lower extremity was applied to the intervention group in three sessions a week and a total of six sessions for two weeks

Primary Outcome Measures

Name	Time	Method
Patient follow-up forms.	during 2 weeks (15 days)	Intradialytic systolic and diastolic blood pressure and ultrafiltration were noted by the investigator, during the HD session
Visual Analog Scala (VAS)	during 2 weeks (15 days)	This scale; There is a number value of "0 (no pain)" at the beginning and "10 (the most unbearable pain)" at the end. Participants marked the scale each time they experience a muscle cramp severity. Baseline measurements; muscle cramp experienced at home and, during the dialysis session.
Muscle cramp assessment short survey (duration and frequency of muscle cramps)	during 2 weeks (15 days)	Participants noted the duration and number of muscle cramps they experienced. Baseline measurements; muscle cramp experienced at home and, during the dialysis session.

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index(PUKİ),	At the first and last meeting in 2 weeks (15 days)	Pittsburgh Sleep Quality Index (PUKI) used to evaluate sleep quality.The total score is between 0-21. PUKİ score of 5 or above indicates poor sleep quality.

Trial Locations

Locations (2)

Ayşe Gül Parlak; 🇹🇷 Kars, Turkey

Kafkas University; 🇹🇷 Kars, Turkey