- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06207669
Music Therapy for Individuals Receiving Hemodialysis Treatment
The Effect of Music Therapy on Itching, Muscle Cramps and Comfort in Individuals Receiving Hemodialysis Treatment
There are studies in the world where music therapy is used in the management of symptoms in hemodialysis, but the number of studies in our country is insufficient. This study will be carried out to determine the effect of music therapy on itching, muscle cramps and comfort level in individuals receiving hemodialysis HD treatment.
The research will be conducted in the Amasya Sabuncuoğlu Şerefeddin Training and Research Hospital Dialysis Unit Hemodialysis Clinic, with a pre-test post-test single group, quasi-experimental research design. The sample of the research; It will constitute 38 individuals aged 18 and over who have been receiving hemodialysis treatment for at least 6 months. Music therapy will be applied to the participants in the clinic for 30 minutes after the 2nd hour of each hemodialysis session for 4 weeks.
Research data will be collected between January and March 2024 using the Introductory Information Form, 5-D Itch Scale, Visual Analog Scale and KHemodialysis Comfort Scale -Version II.
Data collection forms will be applied twice in total, at the end of the 1st session (pretest) and at the end of the 8th session (posttest). The data obtained from the research will be analyzed in the Statistical Package for Social Science (SPSS) 21 statistical program. Variables covering the descriptive characteristics of the participants will be expressed in numbers and percentages. Whether the data has a normal distribution will be determined by the Kolmogrov Smirnov test and parametric and/or nonparametric tests will be used according to the results obtained. Statistical significance value will be accepted as p<.05.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 18 years or older,
- Having been receiving hemodialysis treatment for at least 6 months,
- Being literate,
- Being open to collaboration,
Exclusion Criteria:
- Having sensory loss related to vision, hearing and communication,
- Having a psychiatric illness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Music therapy group
A musical concert will be held for the participants in the Hicaz makam.
|
Music therapy will be applied to individuals in the clinic for 30 minutes after the 2nd hour of each hemodialysis session for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Itch on the 5-D Itch Scale at Week 4
Time Frame: Baseline and Week 4
|
The 5-D Itch Scale is a reliable scale used to evaluate all causes of itching, including the duration, severity, course of itching, distribution in the body, and limitations caused by itching.
On this scale, a total score of at least 5 points indicates no itching, and a maximum score of 25 points indicates very severe itching = (Week 4 Score- Baseline Score).
|
Baseline and Week 4
|
Change from Baseline in Muscle Cramps on the Visual Analog Scale at Week 4
Time Frame: Baseline and Week 4
|
Visual Analog Scale is a scale developed to convert some values that are difficult to measure numerically into numerical values.
It is a scale evaluated on a horizontal line, divided into equal divisions of 10 cm, which includes the patient's impartial evaluation and indicates that one end is very good and the other end is very bad.
The patient is asked to mark the number that best fits their symptoms.
"0" represents the most comfortable situation, and "10" represents the worst situation = (Week 4 Score- Baseline Score).
|
Baseline and Week 4
|
Change from Baseline in Comfort on the Hemodialysis Comfort Scale -Version II at Week 4
Time Frame: Baseline and Week 4
|
Hemodialysis Comfort Scale -Version II consists of 26 items and is a five-point Likert type.
The scale consists of six sub-dimensions: "physical relief, physical relaxation, psychospiritual relaxation, psychospiritual strengthening, environmental strengthening and sociocultural relief".
The minimum score obtained from the scale is 26 and the highest score is 130.
As the points received increase, the comfort of the patients also increases = (Week 4 Score- Baseline Score).
|
Baseline and Week 4
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- amasyau-soner_1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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