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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HOT THERAPY:GROUP A | Experimental | Hot Compress Group |
|
| COLD THERAPY:GROUP B | Experimental | Cold Compress Group |
|
| PLACEBO: GROUP C | Placebo Comparator | Inoperative compress Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hot and Cold compress, nursing interventions | Other | using thermal compress at 38-39 °C (hot) and 15-16 °C (cold) on the distal regions of both lower extremities of the patients |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | At the end of each hemodialysis session, the comfort level of all participants was measured and recorded using the Hemodialysis Comfort Scale | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leyla Özdemir, Prof. Dr. | Hacettepe University | Study Director |
| Tolga Yıldırım, Assos. Prof. | Hacettepe University | Study Director |
| Cebrail Cebrailov, M.D. | Hacettepe University | Study Chair |
| Gülseren Çeliksöz, M.D. | Betamar Dialysis Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University | Ankara | None Selected | 06100 | Turkey (Türkiye) |
In the informed consent form presented to the patients at the beginning of the study, it was clearly stated that individual data would be kept confidential. only data based on study results will be shared as scientific content.
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| ID | Term |
|---|---|
| D013035 | Spasm |
| D005221 | Fatigue |
| D009120 | Muscle Cramp |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D006358 | Hot Temperature |
| D008722 | Methods |
| ID | Term |
|---|---|
| D013696 | Temperature |
| D013816 | Thermodynamics |
| D055585 | Physical Phenomena |
| D014887 | Weather |
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placebo controlled randomized trial
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D001272 |
| Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
| D008919 | Investigative Techniques |