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Hot and Cold Compress in Hemodialysis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04681521
Enrollment
69
Registered
2020-12-23
Start date
2020-02-01
Completion date
2020-11-20
Last updated
2020-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Hemodialysis Complication, Muscle Spasm

Keywords

hemodialysis, muscle cramp, fatigue, comfort, nursing care, complementary therapies

Brief summary

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

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.

Interventions

OTHERHot and Cold compress, nursing interventions

using thermal compress at 38-39 °C (hot) and 15-16 °C (cold) on the distal regions of both lower extremities of the patients

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

placebo controlled randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
muscle cramps4 weeksThroughout 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.

Secondary

MeasureTime frameDescription
Fatigue4 weeksAt the end of each hemodialysis session, the fatigue level of all participants was measured and recorded using the Piper Fatigue Scale.

Other

MeasureTime frameDescription
Comfort4 weeksAt the end of each hemodialysis session, the comfort level of all participants was measured and recorded using the Hemodialysis Comfort Scale

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026