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NCT Number: NCT04681521

Hot and Cold Compress in Hemodialysis

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.

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Key information

Conditions

Hemodialysis Complication Fatigue Muscle Cramp Muscle Spasm Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, None Selected, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. muscle cramps

    Time frame: 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 outcomes

  1. Fatigue

    Time frame: 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 outcomes

  1. Comfort

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 23, 2020
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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