Hemodialysis ComplicationNCT06207669
Music Therapy for Individuals Receiving Hemodialysis Treatment
A study testing Music therapy in people with Hemodialysis Complication, run by Amasya University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 29 Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years or older,
- Having been receiving hemodialysis treatment for at least 6 months,
- Being literate,
- Being open to collaboration,
Who cannot join
- Having sensory loss related to vision, hearing and communication,
- Having a psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music Therapy on Itching, Muscle Cramps and Comfort in Individuals Receiving Hemodialysis Treatment
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.
Read more
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.
Read the 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.
- Conditions
- Hemodialysis Complication
- Being tested
- Music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
Music therapy will be applied to individuals in the clinic for 30 minutes after the 2nd hour of each hemodialysis session for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy group | Experimental | A musical concert will be held for the participants in the Hicaz makam. Receives: Other: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Itch on the 5-D Itch Scale at Week 4
The 5-D Itch Scale is a reliable scale used to evaluate all causes of itching, including the duration, severity, course of itching, distribution in the body, and limitations caused by itching. On this scale, a total score of at least 5 points indicates no itching, and a maximum score of 25 points indicates very severe itching = (Week 4 Score- Baseline Score).
Measured: Baseline and Week 4
Change from Baseline in Muscle Cramps on the Visual Analog Scale at Week 4
Visual Analog Scale is a scale developed to convert some values that are difficult to measure numerically into numerical values. It is a scale evaluated on a horizontal line, divided into equal divisions of 10 cm, which includes the patient's impartial evaluation and indicates that one end is very good and the other end is very bad. The patient is asked to mark the number that best fits their symptoms. "0" represents the most comfortable situation, and "10" represents the worst situation = (Week 4 Score- Baseline Score).
Measured: Baseline and Week 4
Change from Baseline in Comfort on the Hemodialysis Comfort Scale -Version II at Week 4
Hemodialysis Comfort Scale -Version II consists of 26 items and is a five-point Likert type. The scale consists of six sub-dimensions: "physical relief, physical relaxation, psychospiritual relaxation, psychospiritual strengthening, environmental strengthening and sociocultural relief". The minimum score obtained from the scale is 26 and the highest score is 130. As the points received increase, the comfort of the patients also increases = (Week 4 Score- Baseline Score).
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 posted17 Jan 2024
- Study start1 Dec 2023
- Primary completion31 Jan 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soner Telli, Amasya University
- Investigators
- soner telli, M.Sc., Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207669
- Sponsor's protocol ID
- amasyau-soner_1
- Status last verified
- Sep 2024
- First submitted
- 27 Dec 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Itching, Muscle Cramps and Comfort in Individuals Receiving Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT06207669
- Acronym / sponsor ID
- amasyau-soner_1
- Conditions
- Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 17 Jan 2024 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music therapy group | Experimental | Other: Music therapyA musical concert will be held for the participants in the Hicaz makam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 years or older,
- Having been receiving hemodialysis treatment for at least 6 months,
- Being literate,
- Being open to collaboration,
Key exclusion criteria (2 listed)
- Having sensory loss related to vision, hearing and communication,
- Having a psychiatric illness.
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 therapyMusic therapy will be applied to individuals in the clinic for 30 minutes after the 2nd hour of each hemodialysis session for 4 weeks. | Other | Music therapy group |
Primary outcome
Change from Baseline in Itch on the 5-D Itch Scale at Week 4
Time frame: Baseline and Week 4
The 5-D Itch Scale is a reliable scale used to evaluate all causes of itching, including the duration, severity, course of itching, distribution in the body, and limitations caused by itching. On this scale, a total score of at least 5 points indicates no itching, and a maximum score of 25 points indicates very severe itching = (Week 4 Score- Baseline Score).
Change from Baseline in Muscle Cramps on the Visual Analog Scale at Week 4
Time frame: Baseline and Week 4
Visual Analog Scale is a scale developed to convert some values that are difficult to measure numerically into numerical values. It is a scale evaluated on a horizontal line, divided into equal divisions of 10 cm, which includes the patient's impartial evaluation and indicates that one end is very good and the other end is very bad. The patient is asked to mark the number that best fits their symptoms. "0" represents the most comfortable situation, and "10" represents the worst situation = (Week 4 Score- Baseline Score).
Change from Baseline in Comfort on the Hemodialysis Comfort Scale -Version II at Week 4
Time frame: Baseline and Week 4
Hemodialysis Comfort Scale -Version II consists of 26 items and is a five-point Likert type. The scale consists of six sub-dimensions: "physical relief, physical relaxation, psychospiritual relaxation, psychospiritual strengthening, environmental strengthening and sociocultural relief". The minimum score obtained from the scale is 26 and the highest score is 130. As the points received increase, the comfort of the patients also increases = (Week 4 Score- Baseline Score).
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 27 Sep 2024.
Related trials for Hemodialysis Complication
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
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.
soner telli, M.Sc. principal investigator
Amasya 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 therapy in people with Hemodialysis Complication, 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 27 Sep 2024. 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?
Change from Baseline in Itch on the 5-D Itch Scale at Week 4 (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 27 Sep 2024.