Hot and Cold Compress in Hemodialysis

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT04681521

Collaborator

(none)

Enrollment

Location

Arms

9.6

Actual Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis Complication Muscle Spasm Fatigue	Other: Hot and Cold compress, nursing interventions	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

placebo controlled randomized trialplacebo controlled randomized trial

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Oct 30, 2020

Actual Study Completion Date :

Nov 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HOT THERAPY:GROUP A Hot Compress Group	Other: Hot 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
Experimental: COLD THERAPY:GROUP B Cold Compress Group	Other: Hot 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
Placebo Comparator: PLACEBO: GROUP C Inoperative compress Group	Other: Hot 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

Arm

Intervention/Treatment

Experimental: HOT THERAPY:GROUP A

Hot Compress Group

Other: Hot 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

Experimental: COLD THERAPY:GROUP B

Cold Compress Group

Other: Hot 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

Placebo Comparator: PLACEBO: GROUP C

Inoperative compress Group

Other: Hot 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

Outcome Measures

Primary Outcome Measures

muscle cramps [4 weeks]
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.

Secondary Outcome Measures

Fatigue [4 weeks]
At the end of each hemodialysis session, the fatigue level of all participants was measured and recorded using the Piper Fatigue Scale.

Other Outcome Measures

Comfort [4 weeks]
At the end of each hemodialysis session, the comfort level of all participants was measured and recorded using the Hemodialysis Comfort Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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