Clinical trial NCT06865742: Music Therapy Applied During Hemodialysis
Official title: Effects of Music Therapy Applied During Hemodialysis on Fatigue, Sleep Quality and Mental Well-Being
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemodialysis
Keywords: Hemodialysis
Music Therapy
Fatigue
Sleep Quality
Mental Well-Being
nursing
Lead sponsor: Amasya University
Sponsor class: OTHER
Collaborators: name: Erzurum Technical University
First posted: 2025-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled experimental type.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many symptoms are encountered during the hemodialysis treatment process, and fatigue and insomnia are two of the most common symptoms. The management of these symptoms, which negatively affect the quality of life and mental well-being of individuals, is very important. It is known that the effects of pharmacological treatments are limited in the management of symptoms encountered during the HD treatment process, and the tendency towards non-pharmacological methods in symptom management is increasing.

This study will be conducted to determine the effects of music therapy to be applied to individuals receiving HD treatment on fatigue, sleep quality and mental well-being.

This randomized controlled experimental study will be conducted with 60 individuals receiving treatment in the hemodialysis clinic of a public hospital. Individuals will receive 30 minutes of music therapy after the 2nd hour of each hemodialysis session for 4 weeks. Research data will be collected using the Introductory Information Form, Chalder Fatigue Scale, Pittsburgh Sleep Quality Scale and Warwick-Edinburgh Mental Well-Being Scale.

This study is important because it is the first study to evaluate the effects of music therapy on fatigue, sleep quality and mental well-being of individuals receiving HD treatment. It is thought that music therapy applied to individuals receiving HD treatment will contribute to the literature on evidence.

Detailed description: Chronic renal failure (CKD) is a disease characterized by progressive and irreversible nephron loss that develops due to various diseases. In the CKD picture, permanent disorders are observed in the fluid-electrolyte balance and metabolic-endocrine functions of the kidney. Although CKD is a disease that can be prevented and/or its progression rate can be slowed down in the early stages, the low level of awareness about the disease and early diagnosis cause the disease to progress to the final stage, end-stage renal failure (ESRD).

Renal replacement therapies (RRT) such as dialysis and kidney transplantation are applied to individuals diagnosed with ESRD. Hemodialysis (HD) is the most commonly used RRT. The aim of HD treatment is to increase the life span and quality of life of individuals. However, it is known that HD, which is one of the life-preserving treatments, causes many undesirable problems in the physical, psychological, social and economic areas in addition to its targeted effects. Individuals who undergo HD encounter many problems such as diet and fluid restriction, job loss, early retirement, role changes and role losses, disruption in family life, dependence on devices and healthcare institutions, fear of death, depression, physical dysfunction, sexual dysfunction, decreased quality of life, and deterioration in body image and self-esteem. In addition, individuals during the treatment process; They also experience many symptoms such as fatigue, shortness of breath, pain, nausea-vomiting, loss of appetite, muscle cramps, insomnia, itching, drowsiness, irritability, dry skin, dizziness, and restlessness.

Fatigue and insomnia are two of the most common symptoms encountered during the HD treatment process. Fatigue, defined as an uncontrollable feeling of exhaustion, is intensely experienced by individuals receiving HD treatment. In the study by Hindistan and Deniz (2018), fatigue was detected in 83.5% of individuals, in the study by Usta and Demir (2014), in 52.2% of individuals before HD, 43.3% during HD, and 84.4% after HD, and in the study by Ju A et al. (2020), in 60-97% of individuals. It is known that fatigue in individuals receiving HD treatment causes an increase in the level of addiction, a decrease in physical activity level, and quality of life. Another problem that causes a decrease in quality of life and also increases the mortality rate is sleep problems. It has been reported that 60-85% of individuals receiving HD treatment have sleep problems. In the study of Taylan and Özkan (2020), it was determined that the sleep quality of individuals receiving HD treatment was low and 41.2% of the individuals had very poor sleep quality. Sleep problems include problems such as prolonged time to fall asleep, interruptions during sleep, daytime naps and restless leg syndrome.

All problems and symptoms encountered during the HD treatment process negatively affect the quality of life and mental well-being of individuals.The management of symptoms experienced in individuals receiving HD treatment is very important due to their effects on the quality of life and mental well-being. It is known that the effects of pharmacological treatments are limited in the management of symptoms encountered during the HD treatment process. Therefore, the tendency towards non-pharmacological methods in the management of these symptoms is increasing. Reducing symptoms in HD and ensuring the well-being of patients has an important place in terms of quality nursing care. For this reason, nurses can take a holistic approach to individuals receiving HD treatment and perform various interventions.In this context, nurses mostly prefer complementary treatments such as massage, aromatherapy, acupuncture, reflexology, and music therapy from non-pharmacological methods.

Music therapy is one of the important complementary treatments preferred by nurses and is a method used to provide symptom management and has no side effects.

Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older
* Being on HD treatment for at least 6 months
* Being cooperative and having no verbal communication disabilities (hearing or speaking)
* Not having a psychiatric disorder

Exclusion Criteria:

* Having recently attended a similar program
* Not agreeing to participate in the study

Primary outcomes:
measure: Is music therapy effective in reducing fatigue?
timeFrame: Baseline and week 4
measure: Is music therapy effective in improving sleep quality?
timeFrame: Baseline and week 4
measure: Is music therapy effective in improving mental well-being?
timeFrame: Baseline and week 4
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Erzurum Technical University
name: Şeyda Karasu, RA
role: STUDY_CHAIR
References: