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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05750160
Other study ID # KET-1362/UN2.F1/ETIK/PPM.00.02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 13, 2023
Est. completion date March 18, 2023

Study information

Verified date June 2023
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Burnout Syndrome (BOS) can be defined as a state of stress both physically and psychically due to the burden and stressor of high work. The prevalence of BOS in health workers varies between 25-75% globally. Studies have shown that the presence of Burnout syndrome will meaningfully reduce the quality of services related to patient safety and cause immune system disorders that act as the body's defense against viral, bacterial, protozoal and fungal infections. Many strategies have been researched to help prevent and reduce the occurrence of Burnout syndrome, one of which is music therapy. The purpose of this study was to determine the effect of music therapy on the immune response in health workers with Burnout Syndrome. This study is a randomized clinical trial with a pre and post test control group design for health workers at Dr Kariadi General Hospital and Dr. Cipto Mangunkusumo General Hospital. Subjects will be provided with information prior to the study and asked to sign an informed consent sheet if they agree to be involved in the study. Subjects will be divided into control groups and treatment groups with matching age, gender and type of work. In the treatment group, music therapy will be given as much as 3 times a week for 4 weeks. Data were taken on both groups before and after the intervention. This study used the Maslach Burnout Inventory Human Service Survey (MBI-HSS) and blood laboratory examination to determine the value of the Neutrophyl Lymphocyte Ratio, Interleukin 6 and Interleukin 10 levels.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 18, 2023
Est. primary completion date February 18, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. Age 18 years - 60 years old 2. Health workers in the wards and polyclinic of Dr. Cipto Mangunkusumo Hospital or Dr. Kariadi Hospital, including doctors in charge of patients, nurses, residents, and other supporting health workers 3. Included in the Burnout syndrome criteria from the Maslach Burnout Inventory-Human Service Survey questionnaire Exclusion Criteria: 1. Refusing to follow the study 2. Have a history of heart disease, kidney disease, diabetes, cancer, tuberkulosis, autoimmune, immunodeficiency 3. Taking drugs that affect the central nervous system or immunosuppressants 4. Have hearing disorder 5. Have a psychiatric disorder 6. Being pregnant 7. Healthcare workers who don't like music

Study Design


Intervention

Other:
music therapy
Music therapy that have been made by Music Therapist after Focus Group discussion, given three times a week for 4 weeks

Locations

Country Name City State
Indonesia Cipto Mangunkusumo National Hospital Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Burnout syndrome Maslach Burnout Inventory Human Service Survey (MBI-HSS) score change from baseline score at 4 weeks
Primary Neutrophil Lymphocyte Ratio Measured with Fluorescence Flow Cytometry Change from baseline Neutrophil Lymphocyte Ratio at 4 weeks
Primary Interleukin 6 Measured with Fluorescence Immunoassay Change from baseline Interleukin-6 level at 4 weeks
Primary Interleukin 10 Measured with ELISA Change from baseline Interleukin-10 level at 4 weeks
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