Hot and Cold Compress in Hemodialysis

NCT04681521 | Completed DMC

• 1 other identifier: KA-19143
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication; Muscle Spasm; Fatigue

Keywords

hemodialysis; muscle cramp; fatigue; comfort; nursing care; complementary therapies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fatigue

  4 weeks

Other Outcomes (1)

• Comfort

  4 weeks

Study Arms (3)

HOT THERAPY:GROUP A

EXPERIMENTAL

Hot Compress Group

Other: Hot and Cold compress, nursing interventions

COLD THERAPY:GROUP B

EXPERIMENTAL

Cold Compress Group

Other: Hot and Cold compress, nursing interventions

PLACEBO: GROUP C

PLACEBO COMPARATOR

Inoperative compress Group

Other: Hot and Cold compress, nursing interventions

Interventions

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

COLD THERAPY:GROUP B; HOT THERAPY:GROUP A; PLACEBO: GROUP C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, None Selected, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spasm; Fatigue; Muscle Cramp

Interventions

Hot Temperature; Methods

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Investigative Techniques

Study Officials

• Leyla Özdemir, Prof. Dr.

  Hacettepe University

  STUDY DIRECTOR

• Tolga Yıldırım, Assos. Prof.

  Hacettepe University

  STUDY DIRECTOR

• Cebrail Cebrailov, M.D.

  Hacettepe University

  STUDY CHAIR

• Gülseren Çeliksöz, M.D.

  Betamar Dialysis Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: placebo controlled randomized trial

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 23, 2020
• Study Start: February 1, 2020
• Primary Completion: October 30, 2020
• Study Completion: November 20, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)