Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2020-02-01
2020-11-20
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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HOT THERAPY:GROUP A
Hot Compress Group
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
COLD THERAPY:GROUP B
Cold Compress Group
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: GROUP C
Inoperative compress Group
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Hacettepe University
OTHER
Responsible Party
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Gülşah Kesik
Principal Investigator
Principal Investigators
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Leyla Özdemir, Prof. Dr.
Role: STUDY_DIRECTOR
Hacettepe University
Tolga Yıldırım, Assos. Prof.
Role: STUDY_DIRECTOR
Hacettepe University
Cebrail Cebrailov, M.D.
Role: STUDY_CHAIR
Hacettepe University
Gülseren Çeliksöz, M.D.
Role: STUDY_CHAIR
Betamar Dialysis Center
Locations
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Hacettepe University
Ankara, None Selected, Turkey (Türkiye)
Countries
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Other Identifiers
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KA-19143
Identifier Type: -
Identifier Source: org_study_id