Clinical trial NCT06865729: Effect of Music Therapy on Hospital Anxiety/Depression and Comfort Level
Official title: Effect of Music Therapy Applied to Hospitalized Chronically Ill Individuals on Hospital Anxiety, Depression and Comfort Levels: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Having been diagnosed with any psychiatric/neurological disease
* Having problems with sensory perception and communication skills

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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.
measure: Shortened General Comfort Questionnaire (SGCQ)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Amasya University
state: Amasya
Study officials:
affiliation: Amasya University
name: Kübra Sarı, MSc
role: PRINCIPAL_INVESTIGATOR
References: