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HemodialysisNCT06865742

Music Therapy Applied During Hemodialysis

A study testing Music intervention in people with Hemodialysis, run by Amasya University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemodialysis
What is being tested?
Music intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Nov 2025to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Amasya University

    Amasya, Amasya, 5100

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Music Therapy Applied During Hemodialysis on Fatigue, Sleep Quality and Mental Well-Being

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.

Read more

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.

Read the 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.

Conditions
Hemodialysis
Being tested
Music intervention
Keywords
Hemodialysis, Music Therapy, Fatigue, Sleep Quality, Mental Well-Being, nursing
Medical subject headings
Fatigue, Sleep Initiation and Maintenance Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music interventionBehavioural

    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.

Study groups in NCT06865742
Study groupRoleWhat they receive
Music therapy/Experimental groupExperimentalThis group will receive music therapy for 30 minutes after the 2nd hour of each hemodialysis session for 4 weeks.
Receives: Behavioral: Music intervention
Control groupNo interventionNo intervention will be performed in this group. Individuals will receive their routine care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and week 4

  2. 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".

    Measured: Baseline and week 4

  3. 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.

    Measured: Baseline and week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start3 Nov 2025
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a randomized controlled experimental type.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06865742
Sponsor's protocol ID
AmasyaU-mçy
Status last verified
Mar 2025
First submitted
12 Feb 2025
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Questions about this trial

What is this clinical trial studying?

A study testing Music intervention in people with Hemodialysis, run by Amasya University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Is music therapy effective in reducing fatigue? (time frame: Baseline and week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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