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Hot and Cold Compress in Hemodialysis

Primary Purpose

Hemodialysis Complication, Muscle Spasm, Fatigue

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Hot and Cold compress, nursing interventions

About this trial

This is an interventional prevention trial for Hemodialysis Complication focused on measuring hemodialysis, muscle cramp, fatigue, comfort, nursing care, complementary therapies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

HOT THERAPY:GROUP A

COLD THERAPY:GROUP B

PLACEBO: GROUP C

Arm Description

Hot Compress Group

Cold Compress Group

Inoperative compress Group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Fatigue

At the end of each hemodialysis session, the fatigue level of all participants was measured and recorded using the Piper Fatigue Scale.

Full Information

NCT ID

NCT04681521

First Posted

December 15, 2020

Last Updated

December 18, 2020

Sponsor

Hacettepe University

1. Study Identification

Unique Protocol Identification Number

NCT04681521

Brief Title

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

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

October 30, 2020 (Actual)

Study Completion Date

November 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemodialysis Complication, Muscle Spasm, Fatigue

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

placebo controlled randomized trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HOT THERAPY:GROUP A

Arm Type

Experimental

Arm Description

Hot Compress Group

Arm Title

COLD THERAPY:GROUP B

Arm Type

Experimental

Arm Description

Cold Compress Group

Arm Title

PLACEBO: GROUP C

Arm Type

Placebo Comparator

Arm Description

Inoperative compress Group

Intervention Type

Other

Intervention Name(s)

Hot and Cold compress, nursing interventions

Intervention Description

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 Outcome Measure Information:

Title

muscle cramps

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Fatigue

Description

At the end of each hemodialysis session, the fatigue level of all participants was measured and recorded using the Piper Fatigue Scale.

Time Frame

4 weeks

Other Pre-specified Outcome Measures:

Title

Comfort

Description

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

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leyla Özdemir, Prof. Dr.

Organizational Affiliation

Hacettepe University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Tolga Yıldırım, Assos. Prof.

Organizational Affiliation

Hacettepe University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Cebrail Cebrailov, M.D.

Organizational Affiliation

Hacettepe University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Gülseren Çeliksöz, M.D.

Organizational Affiliation

Betamar Dialysis Center

Official's Role

Study Chair

Facility Information:

Facility Name

Hacettepe University

City

Ankara

State/Province

None Selected

ZIP/Postal Code

06100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Learn more about this trial

Hot and Cold Compress in Hemodialysis

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