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

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Hemodialysis Complication; Muscle Spasm
• Intervention / Treatment: Other: Hot and Cold compress, nursing interventions

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • None Selected
    • Ankara, None Selected, Turkey, 06100
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Director: Leyla Özdemir, Prof. Dr., Hacettepe University; Study Director: Tolga Yıldırım, Assos. Prof., Hacettepe University; Study Chair: Cebrail Cebrailov, M.D., Hacettepe University; Study Chair: Gülseren Çeliksöz, M.D., Betamar Dialysis Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: fatigue; comfort; hemodialysis; complementary therapies; muscle cramp; nursing care
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Fatigue; Spasm
• Other Study ID Numbers: KA-19143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No