Hot and Cold Compress in Hemodialysis

Study Overview
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Brief Summary
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Aims and objectives. To examine and compare the effects of hot and cold compresses administration on muscle cramps, fatigue, and comfort in hemodialysis (HD) patients. Background. Muscle cramps and fatigue are common complications in HD patients and reduce patient comfort. Among the nursing interventions stated for the management of these complications in the literature, hot and cold therapy are remarkable. To the best of our knowledge, the present study is the first research up to date that examined and compared the effects of hot and cold compress administrations on abovementioned complications in HD. Design. This placebo-controlled randomized trial was conducted in two hemodialysis centers between February and October 2020. Methods. The study sample consisted of 69 patients, stratified and randomly allocated to two intervention groups and placebo group. For patients of each group, the implementation of the study continued for four weeks, 12 HD sessions.

Detailed Description
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Hemodialysis (HD) is a common renal replacement therapy used in the treatment of End-Stage Renal Disease (ESRD) worldwide. Although HD is a life-saving treatment for people with ESRD, it causes some acute and chronic complications. Muscle cramps and fatigue are two of the most common complications in HD, and these also cause reducing comfort. Management of complications in HD patients and ensuring an optimal comfort level are pivotal for nurses. According to the literature, recommended nursing practices for the management of cramps in HD patients include hot and cold therapy methods. Besides, preventing cramps can improve comfort by reducing fatigue. Therefore, this study aimed to examine and compare the effects of hot and cold compresses administration on muscle cramps, fatigue, and comfort in hemodialysis (HD) patients.

Official Title
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The Effects of Hot and Cold Compress on Muscle Cramps, Fatigue And Comfort in Hemodialysis Patients: A Placebo Controlled Randomized Trial

Conditions
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Hemodialysis Complication, Muscle Spasm, Fatigue

Intervention / Treatment
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* Other: Hot and Cold compress, nursing interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between the ages of 18-65, receiving HD treatment for at least six months, three days a week with four-hour sessions with blood pressure 120/80 mmHg and higher at the beginning of the HD session, did not develop intradialytic hypotension in the first two hours of HD, hemoglobin value above 8.0 mg/dL, having a stable dry weight for the previous month (less than 2 kg change). Exclusion Criteria: receiving intravenous electrolyte replacement during HD session, having a condition that prevented hot or cold administration such as diabetic neuropathy, burns, open wounds, and amputation in the lower extremities, with an oncological diagnosis or autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, fibromyalgia, etc.), refused to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: placebo controlled randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HOT THERAPY:GROUP A<br>Hot Compress Group | Other: Hot and Cold compress, nursing interventions<br>* using thermal compress at 38-39 °C (hot) and 15-16 °C (cold) on the distal regions of both lower extremities of the patients<br>|
| Experimental: COLD THERAPY:GROUP B<br>Cold Compress Group | Other: Hot and Cold compress, nursing interventions<br>* using thermal compress at 38-39 °C (hot) and 15-16 °C (cold) on the distal regions of both lower extremities of the patients<br>|
| Placebo Comparator: PLACEBO: GROUP C<br>Inoperative compress Group | Other: Hot and Cold compress, nursing interventions<br>* using thermal compress at 38-39 °C (hot) and 15-16 °C (cold) on the distal regions of both lower extremities of the patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle cramps | Throughout the hemodialysis treatment, the patients were monitored in terms of cramp development and cramp development was recorded in the follow-up chart (CEFC). This chart was created by the researcher through literature review. Each involuntary contraction session in the legs of the patients was evaluated as an episode. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | At the end of each hemodialysis session, the fatigue level of all participants was measured and recorded using the Piper Fatigue Scale. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, muscle cramp, fatigue, comfort, nursing care, complementary therapies