Chronic DiseaseNCT06865729
Effect of Music Therapy on Hospital Anxiety/Depression and Comfort Level
A study testing Music therapy in people with Chronic Disease, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
Aim: It has been determined that there are limited studies in our country where music is used as a nursing intervention and the effects of music therapy on the psychological symptoms and comfort levels of individuals with chronic diseases are evaluated. Read more about this study
- Who is it for?
- Ages 18 hours and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2024to 28 Feb 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 hours and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being over 18 years of age
- Being hospitalized due to a chronic disease
- Speaking and understanding Turkish
- Not using any medication that would affect anxiety and depression
- Giving consent to participate in the study
Who cannot join
- Having been diagnosed with any psychiatric/neurological disease
- Having problems with sensory perception and communication skills
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Music Therapy Applied to Hospitalized Chronically Ill Individuals on Hospital Anxiety, Depression and Comfort Levels: A Randomized Controlled Trial
Aim: It has been determined that there are limited studies in our country where music is used as a nursing intervention and the effects of music therapy on the psychological symptoms and comfort levels of individuals with chronic diseases are evaluated. This study will be conducted to determine the effects of music therapy applied to hospitalized individuals with chronic diseases on hospital anxiety, depression and comfort levels.
The research will be conducted at the Urology Department of Merzifon Kara Mustafa Paşa State Hospital between September 2024 and May 2025. The research is a randomized controlled experimental type. The sample of the research will consist of 60 participants, 30 in the music therapy group and 30 in the control group, who are 18 years of age and older and diagnosed with chronic diseases.
Read more
Data in the research: The research data will be collected using the Personal Information Form, Hospital Anxiety and Depression Scale and General Comfort Scale Short Form.
In this study, music therapy will be performed by the researchers for 4 days (the average length of stay of inpatients is 4 days), starting from the first day the participants start their inpatient treatment in the hospital. The data collection forms will be applied twice in total, at the first interview (pre-test) and on the morning of the 5th day (post-test).
Read the detailed description
It has been determined that anxiety and depression in individuals with chronic diseases are strongly and independently associated with mental health and physical symptom burden, and depression also has an important relationship with quality of life areas. Anxiety and depression negatively affect the continuation of treatment, its effectiveness and the quality of life of individuals in chronic diseases. All these negative situations experienced by patients also cause a decrease in comfort. Elimination or reduction of situations that disturb patients is only possible by increasing comfort. It is known that patients with a high level of comfort recover more quickly and can cope with the disease process more easily.
Various pharmacological treatments are applied to alleviate the anxiety and depression levels in individuals with chronic diseases, and these treatments have important side effects that affect the body and mind. For this reason, the use of non-pharmacological treatments such as cognitive behavioral therapy, physical activity, group therapies, relaxation and dreaming methods, aromatherapy, laughter therapy and hypnosis has become privileged in overcoming depression and anxiety in individuals with chronic diseases. Music therapy is another non-pharmacological treatment frequently used to relieve depression and anxiety.
Data analysis: The data obtained from the research will be analyzed in the Statistical Package for Social Science (SPSS) 21 statistical program. Variables covering the introductory characteristics of individuals with chronic diseases will be expressed as numbers and percentages. The Shapiro-Wilk test will determine whether the data show a normal distribution and parametric and/or non-parametric tests will be used according to the results obtained. Statistical significance will be accepted as p<.05.
- Conditions
- Chronic Disease
- Being tested
- Music therapy
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
Music therapy will be performed by the researchers for 4 days (average length of stay for inpatients is 4 days), starting from the first day the patients start their inpatient treatment. Music therapy will be performed in the evening hours (between 20:00 and 21:00) and in the patients' own rooms, so as not to disrupt the patients' routine follow-up and treatment. Music therapy will be performed passively using an MP3 music player and headphones provided by the researchers. Therapy time will be limited to 30 minutes. Music therapy will be performed in one session per day for 4 days, and the patients will listen to the same music in each session.
| Study group | Role | What they receive |
|---|---|---|
| Participant Group | Experimental | Music Therapy Receives: Behavioral: Music therapy |
| Control Group | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS)
The scale was developed by Zigmond and Snaith (1983).The adaptation of the scale to Turkish and its validity and reliability analyses were conducted by Aydemir et al. in 1997.The scale consists of 14 items. Odd-numbered items investigate anxiety and even-numbered items investigate depression.The scale is a four-point Likert-type assessment tool and the scores of the items range from 0 to 3.However, each item is scored differently; items 1, 3, 5, 6, 8, 10, 11 and 13 show decreasing severity and are scored as 3, 2, 1, 0. On the other hand, items 2, 4, 7, 9, 12 and 14 are scored as 0, 1, 2, 3.The total scores of the subscales are obtained by summing the scores of these items.For the anxiety subscale, items 1, 3, 5, 7, 9, 11 and 13 are added; for the depression subscale, items 2, 4, 6, 8, 10, 12 and 14 are added.The cut-off point for the anxiety subscale of the Turkish form of the Hospital Anxiety and Depression Scale was found to be 10, and the cut-off point for the depression subscale.
Measured: A pre-test will be applied after the patients are admitted to the clinic. The post-test will be applied on the 5th day of the patients' hospitalization.
Shortened General Comfort Questionnaire (SGCQ)
The scale was developed by Kolcaba in 2006. The Turkish validity and reliability study of the scale was conducted by Çıtlık Sarıtaş et al. (2018). The scale consists of 28 items and the items of the scale are scored between 28-168. The lowest possible value, 1, indicates low comfort, and the highest value, 6, indicates high comfort. The General Comfort Scale Short Form includes the sub-dimensions of Relief (9 items), Relaxation (9 items), and Superiority (10 items). The total score obtained is divided by the number of scale items to find the mean value. The Cronbach alpha reliability coefficient of the Turkish form of the scale was found to be 0.82. The Cronbach alpha reliability coefficients of the scale sub-dimensions (relief, relaxation, and superiority) were found to be 0.81, 0.81, and 0.76, respectively.
Measured: A pre-test will be applied after the patients are admitted to the clinic. The post-test will be applied on the 5th day of the patients' hospitalization.
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 start11 Sep 2024
- Primary completion17 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübras, Amasya University
- Investigators
- Kübra Sarı, MSc, Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865729
- Sponsor's protocol ID
- AUSBF-SARI-001
- Status last verified
- Mar 2025
- First submitted
- 26 Nov 2024
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Therapy Applied to Hospitalized Chronically Ill Individuals on Hospital Anxiety, Depression and Comfort Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06865729
- Acronym / sponsor ID
- AUSBF-SARI-001
- Conditions
- Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 28 Feb 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.
Aim: It has been determined that there are limited studies in our country where music is used as a nursing intervention and the effects of music therapy on the psychological symptoms and comfort levels of individuals with chronic diseases are evaluated. This study will be conducted to determine the effects of music therapy applied to hospitalized individuals with chronic diseases on hospital anxiety, depression and comfort levels.
The research will be conducted at the Urology Department of Merzifon Kara Mustafa Paşa State Hospital between September 2024 and May 2025. The research is a randomized controlled experimental type. The sample of the research will consist of 60 participants, 30 in the music therapy group and 30 in the control group, who are 18 years of age and older and diagnosed with chronic diseases.
Data in the research: The research data will be collected using the Personal Information Form, Hospital Anxiety and Depression Scale and General Comfort Scale Short Form.
In this study, music therapy will be performed by the researchers for 4 days (the average length of stay of inpatients is 4 days), starting from the first day the participants start their inpatient treatment in the hospital. The data collection forms will be applied twice in total, at the first interview (pre-test) and on the morning of the 5th day (post-test).
Detailed description
It has been determined that anxiety and depression in individuals with chronic diseases are strongly and independently associated with mental health and physical symptom burden, and depression also has an important relationship with quality of life areas. Anxiety and depression negatively affect the continuation of treatment, its effectiveness and the quality of life of individuals in chronic diseases. All these negative situations experienced by patients also cause a decrease in comfort. Elimination or reduction of situations that disturb patients is only possible by increasing comfort. It is known that patients with a high level of comfort recover more quickly and can cope with the disease process more easily.
Various pharmacological treatments are applied to alleviate the anxiety and depression levels in individuals with chronic diseases, and these treatments have important side effects that affect the body and mind. For this reason, the use of non-pharmacological treatments such as cognitive behavioral therapy, physical activity, group therapies, relaxation and dreaming methods, aromatherapy, laughter therapy and hypnosis has become privileged in overcoming depression and anxiety in individuals with chronic diseases. Music therapy is another non-pharmacological treatment frequently used to relieve depression and anxiety.
Data analysis: The data obtained from the research will be analyzed in the Statistical Package for Social Science (SPSS) 21 statistical program. Variables covering the introductory characteristics of individuals with chronic diseases will be expressed as numbers and percentages. The Shapiro-Wilk test will determine whether the data show a normal distribution and parametric and/or non-parametric tests will be used according to the results obtained. Statistical significance will be accepted as p<.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant Group | Experimental | Behavioral: Music therapyMusic Therapy |
| Control Group | No intervention | –Control Group |
Who may qualify
- Ages
- 18 hours and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Being over 18 years of age
- Being hospitalized due to a chronic disease
- Speaking and understanding Turkish
- Not using any medication that would affect anxiety and depression
- Giving consent to participate in the study
Key exclusion criteria (2 listed)
- Having been diagnosed with any psychiatric/neurological disease
- Having problems with sensory perception and communication skills
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 performed by the researchers for 4 days (average length of stay for inpatients is 4 days), starting from the first day the patients start their inpatient treatment. Music therapy will be performed in the evening hours (between 20:00 and 21:00) and in the patients' own rooms, so as not to disrupt the patients' routine follow-up and treatment. Music therapy will be performed passively using an MP3 music player and headphones provided by the researchers. Therapy time will be limited to 30 minutes. Music therapy will be performed in one session per day for 4 days, and the patients will listen to the same music in each session. | Behavioural | Participant Group |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: A pre-test will be applied after the patients are admitted to the clinic. The post-test will be applied on the 5th day of the patients' hospitalization.
The scale was developed by Zigmond and Snaith (1983).The adaptation of the scale to Turkish and its validity and reliability analyses were conducted by Aydemir et al. in 1997.The scale consists of 14 items. Odd-numbered items investigate anxiety and even-numbered items investigate depression.The scale is a four-point Likert-type assessment tool and the scores of the items range from 0 to 3.However, each item is scored differently; items 1, 3, 5, 6, 8, 10, 11 and 13 show decreasing severity and are scored as 3, 2, 1, 0. On the other hand, items 2, 4, 7, 9, 12 and 14 are scored as 0, 1, 2, 3.The total scores of the subscales are obtained by summing the scores of these items.For the anxiety subscale, items 1, 3, 5, 7, 9, 11 and 13 are added; for the depression subscale, items 2, 4, 6, 8, 10, 12 and 14 are added.The cut-off point for the anxiety subscale of the Turkish form of the Hospital Anxiety and Depression Scale was found to be 10, and the cut-off point for the depression subscale.
Shortened General Comfort Questionnaire (SGCQ)
Time frame: A pre-test will be applied after the patients are admitted to the clinic. The post-test will be applied on the 5th day of the patients' hospitalization.
The scale was developed by Kolcaba in 2006. The Turkish validity and reliability study of the scale was conducted by Çıtlık Sarıtaş et al. (2018). The scale consists of 28 items and the items of the scale are scored between 28-168. The lowest possible value, 1, indicates low comfort, and the highest value, 6, indicates high comfort. The General Comfort Scale Short Form includes the sub-dimensions of Relief (9 items), Relaxation (9 items), and Superiority (10 items). The total score obtained is divided by the number of scale items to find the mean value. The Cronbach alpha reliability coefficient of the Turkish form of the scale was found to be 0.82. The Cronbach alpha reliability coefficients of the scale sub-dimensions (relief, relaxation, and superiority) were found to be 0.81, 0.81, and 0.76, respectively.
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 10 Mar 2025.
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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.
Kübra Sarı, MSc 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 Chronic Disease, 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 5 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 10 Mar 2025. 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?
Hospital Anxiety and Depression Scale (HADS) (time frame: A pre-test will be applied after the patients are admitted to the clinic. The post-test will be applied on the 5th day of the patients' hospitalization.). The study lists 2 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 10 Mar 2025.