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).
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Music intervention |
| Control group | No intervention | No 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.
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
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
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.
- First posted10 Mar 2025
- Study start3 Nov 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Collaborators
- Erzurum Technical University
- Responsible party
- Sponsor
- Investigators
- Şeyda Karasu, RA, Study chair, Erzurum Technical University
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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Therapy Applied During Hemodialysis on Fatigue, Sleep Quality and Mental Well-Being
- ClinicalTrials.gov ID
- NCT06865742
- Acronym / sponsor ID
- AmasyaU-mçy
- Conditions
- Hemodialysis
- Keywords
- Hemodialysis, Music Therapy, Fatigue, Sleep Quality, Mental Well-Being, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Collaborators
- Erzurum Technical University
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized controlled experimental type.
| Arm | Type | Receives |
|---|---|---|
| Music therapy/Experimental group | Experimental | Behavioral: Music interventionThis group will receive music therapy for 30 minutes after the 2nd hour of each hemodialysis session for 4 weeks. |
| Control group | No intervention | –No intervention will be performed in this group. Individuals will receive their routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Having recently attended a similar program
- Not agreeing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionThis is the first study to evaluate the effects of music therapy on fatigue, sleep quality and mental well-being of individuals receiving HD treatment. | Behavioural | Music therapy/Experimental group |
Primary outcome
Is music therapy effective in reducing fatigue?
Time frame: Baseline and week 4
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.
Is music therapy effective in improving sleep quality?
Time frame: Baseline and week 4
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".
Is music therapy effective in improving mental well-being?
Time frame: Baseline and week 4
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Hemodialysis
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Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
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Cycling During Dialysis: A Feasibility and Safety Study
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Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şeyda Karasu, RA study chair
Erzurum Technical University
1 site in 1 country: see every site and its status.
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.