Music Therapy Applied During Hemodialysis

NCT06865742 | Not Yet Recruiting

• 1 other identifier: AmasyaU-mçy
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemodialysis

Keywords

Hemodialysis; Music Therapy; Fatigue; Sleep Quality; Mental Well-Being; nursing

Outcome Measures

Primary Outcomes (3)

• Is music therapy effective in reducing fatigue?

  The scale is a 4-point Likert type. The physical fatigue subscale score and the mental fatigue subscale score of the scale are added to obtain the general fatigue score. The physical fatigue subscale score can vary between 0-21, the mental fatigue subscale score between 0-12, and the total fatigue score between 0-33. An increase in the scale score indicates an increase in fatigue severity.

  Baseline and week 4

• Is music therapy effective in improving sleep quality?

  The scale evaluates sleep quality in the last month. It consists of 19 questions and seven subscales, and 18 items are included in the scoring. Each item is evaluated on a 0-3 scale, and the total scale score is the sum of the seven subscale scores. The total score that can be obtained from the scale varies between 0-21, with a high score indicating poor sleep quality. A total scale score of ≤5 indicates "good sleep", and a score of \>5 indicates "bad sleep".

  Baseline and week 4

• Is music therapy effective in improving mental well-being?

  The scale consists of 14 items and is a 5-point Likert type. Scores range from 14 to 70. High scores indicate high psychological well-being.

  Baseline and week 4

Study Arms (2)

Music therapy/Experimental group

EXPERIMENTAL

This group will receive music therapy for 30 minutes after the 2nd hour of each hemodialysis session for 4 weeks.

Behavioral: Music intervention

Control group

NO INTERVENTION

No intervention will be performed in this group. Individuals will receive their routine care.

Interventions

Music intervention BEHAVIORAL

This is the first study to evaluate the effects of music therapy on fatigue, sleep quality and mental well-being of individuals receiving HD treatment.

Music therapy/Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Amasya University: lead
• Erzurum Technical University: collaborator

MeSH Terms

Conditions

Fatigue; Sleep Initiation and Maintenance Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Şeyda Karasu, RA

  Erzurum Technical University

  STUDY CHAIR

Central Study Contacts

Merve Çayır Yılmaz, asst. prof.

CONTACT

+90 5428042263; merve.yilmaz@amasya.edu.tr

Şeyda Karasu, RA

CONTACT

+90 5455495825; seyda.kelle@erzurum.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized controlled experimental type.

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 10, 2025
• Study Start: November 3, 2025
• Primary Completion: December 5, 2025
• Study Completion: December 31, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share