Music Therapy for Individuals Receiving Hemodialysis Treatment

NCT06207669 | Completed

• 1 other identifier: amasyau-soner_1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Itch on the 5-D Itch Scale at 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

  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

  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

Study Arms (1)

Music therapy group

EXPERIMENTAL

A musical concert will be held for the participants in the Hicaz makam.

Other: Music therapy

Interventions

Music therapy OTHER

Music therapy will be applied to individuals in the clinic for 30 minutes after the 2nd hour of each hemodialysis session for 4 weeks.

Music therapy group

Eligibility Criteria

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

You may qualify if:

• Being 18 years or older,
• Having been receiving hemodialysis treatment for at least 6 months,
• Being literate,
• Being open to collaboration,

You may not qualify if:

• Having sensory loss related to vision, hearing and communication,
• Having a psychiatric illness.

Sponsors & Collaborators

• Amasya University: lead

Study Sites (1)

Amasya University

Amasya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• soner telli, M.Sc.

  Amasya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master student

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 17, 2024
• Study Start: December 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 29, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

TU (1)