Clinical trial NCT04681521: Hot and Cold Compress in Hemodialysis
Official title: The Effects of Hot and Cold Compress on Muscle Cramps, Fatigue And Comfort in Hemodialysis Patients: A Placebo Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Muscle Spasm
Fatigue
Keywords: hemodialysis
muscle cramp
fatigue
comfort
nursing care
complementary therapies
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo controlled randomized trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: muscle cramps
timeFrame: 4 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: 4 weeks
Other outcomes:
measure: Comfort
timeFrame: 4 weeks
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: None Selected
Study officials:
affiliation: Hacettepe University
name: Leyla Özdemir, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Tolga Yıldırım, Assos. Prof.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Cebrail Cebrailov, M.D.
role: STUDY_CHAIR
affiliation: Betamar Dialysis Center
name: Gülseren Çeliksöz, M.D.
role: STUDY_CHAIR
References: