Clinical trial NCT06207669: Music Therapy for Individuals Receiving Hemodialysis Treatment
Official title: The Effect of Music Therapy on Itching, Muscle Cramps and Comfort in Individuals Receiving Hemodialysis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Hemodialysis treatment aims to increase the life expectancy and quality of life of individuals. However, it is known that hemodialysis, which is a life-preserving treatment, causes many undesirable problems in physical, psychological, social and economic areas, in addition to its targeted effects. Muscle cramps and itching are two of the most common symptoms during the hemodialysis treatment process, and it is known that all problems and symptoms encountered during the treatment process negatively affect the quality of life and comfort level of individuals. Management of symptoms experienced by individuals receiving hemodialysis treatment is very important due to their effects on both quality of life and comfort level. It is known that the effects of pharmacological treatments are limited in the management of symptoms encountered during the treatment process. Therefore, there is an increasing trend towards non-pharmacological methods in the management of these symptoms. Music therapy is one of the important complementary treatments preferred by nurses and is a method used to manage symptoms and has no side effects. With music therapy, physical, psychological, emotional and social well-being is increased by utilizing the therapeutic aspect of music.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Itch on the 5-D Itch Scale at Week 4
timeFrame: Baseline and Week 4
measure: Change from Baseline in Muscle Cramps on the Visual Analog Scale at Week 4
timeFrame: Baseline and Week 4
measure: Change from Baseline in Comfort on the Hemodialysis Comfort Scale -Version II at Week 4
timeFrame: Baseline and Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Amasya
country: Turkey
facility: Amasya University
Study officials:
affiliation: Amasya University
name: soner telli, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: