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

Study Overview
=================
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.

Official Title
-----------------
The Effect of the Massage on Cramp Frequency, Cramp Severity, and Sleep Quality of Hemodialysis Patients With Complaint of Cramp

Conditions
-----------------
Muscular Cramps, Hemodialysis

Intervention / Treatment
-----------------
* Behavioral: intradialytic massage


Participation Criteria
=================
Eligibility Criteria
-----------------
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (massage group)<br>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 | Behavioral: intradialytic massage<br>* intradialytic massage for lower extremity ( the massage included both feet and legs up to and including the knee) applied to the intervention group in three sessions a week and a total of six sessions for two weeks<br>|
| No Intervention: Control group<br>not administered except nursing interventions in the HD unit. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scala (VAS) | 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. | during 2 weeks (15 days) | 
| Muscle cramp assessment short survey (duration and frequency of muscle cramps) | Participants noted the duration and number of muscle cramps they experienced. Baseline measurements; muscle cramp experienced at home and, during the dialysis session. | during 2 weeks (15 days) | 
| Patient follow-up forms. | Intradialytic systolic and diastolic blood pressure and ultrafiltration were noted by the investigator, during the HD session | during 2 weeks (15 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index(PUKİ), | 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. | At the first and last meeting in 2 weeks (15 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, massage, muscle cramps, sleep quality