- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05750160
Music Therapy on Neutrophyl Lymphocytes Ratio, Interleukin 6 and Interleukin 10 Levels of Burnout Syndrome
The Effect of Music Therapy on Neutrophyl Lymphocytes Ratio, Interleukin 6 and Interleukin 10 Levels of Healthcare Workers With Burnout Syndrome
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jakarta, Indonesia
- Cipto Mangunkusumo National Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years - 60 years old
- 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
- Included in the Burnout syndrome criteria from the Maslach Burnout Inventory-Human Service Survey questionnaire
Exclusion Criteria:
- Refusing to follow the study
- Have a history of heart disease, kidney disease, diabetes, cancer, tuberkulosis, autoimmune, immunodeficiency
- Taking drugs that affect the central nervous system or immunosuppressants
- Have hearing disorder
- Have a psychiatric disorder
- Being pregnant
- Healthcare workers who don't like music
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Given education only
|
|
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Experimental: Intervention
Given education and music therapy
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Music therapy that have been made by Music Therapist after Focus Group discussion, given three times a week for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Burnout syndrome
Time Frame: change from baseline score at 4 weeks
|
Maslach Burnout Inventory Human Service Survey (MBI-HSS) score
|
change from baseline score at 4 weeks
|
|
Neutrophil Lymphocyte Ratio
Time Frame: Change from baseline Neutrophil Lymphocyte Ratio at 4 weeks
|
Measured with Fluorescence Flow Cytometry
|
Change from baseline Neutrophil Lymphocyte Ratio at 4 weeks
|
|
Interleukin 6
Time Frame: Change from baseline Interleukin-6 level at 4 weeks
|
Measured with Fluorescence Immunoassay
|
Change from baseline Interleukin-6 level at 4 weeks
|
|
Interleukin 10
Time Frame: Change from baseline Interleukin-10 level at 4 weeks
|
Measured with ELISA
|
Change from baseline Interleukin-10 level at 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KET-1362/UN2.F1/ETIK/PPM.00.02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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