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Music Therapy on Neutrophyl Lymphocytes Ratio, Interleukin 6 and Interleukin 10 Levels of Burnout Syndrome

Primary Purpose

Burnout Syndrome, Neutrophil-Lymphocyte Ratio, Interleukin-6

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
music therapy
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burnout Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cipto Mangunkusumo National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Given education only

Given education and music therapy

Outcomes

Primary Outcome Measures

Burnout syndrome
Maslach Burnout Inventory Human Service Survey (MBI-HSS) score
Neutrophil Lymphocyte Ratio
Measured with Fluorescence Flow Cytometry
Interleukin 6
Measured with Fluorescence Immunoassay
Interleukin 10
Measured with ELISA

Secondary Outcome Measures

Full Information

First Posted
January 15, 2023
Last Updated
June 1, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05750160
Brief Title
Music Therapy on Neutrophyl Lymphocytes Ratio, Interleukin 6 and Interleukin 10 Levels of Burnout Syndrome
Official Title
The Effect of Music Therapy on Neutrophyl Lymphocytes Ratio, Interleukin 6 and Interleukin 10 Levels of Healthcare Workers With Burnout Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
February 18, 2023 (Actual)
Study Completion Date
March 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout Syndrome, Neutrophil-Lymphocyte Ratio, Interleukin-6, Interleukin-10

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Given education only
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Given education and music therapy
Intervention Type
Other
Intervention Name(s)
music therapy
Intervention Description
Music therapy that have been made by Music Therapist after Focus Group discussion, given three times a week for 4 weeks
Primary Outcome Measure Information:
Title
Burnout syndrome
Description
Maslach Burnout Inventory Human Service Survey (MBI-HSS) score
Time Frame
change from baseline score at 4 weeks
Title
Neutrophil Lymphocyte Ratio
Description
Measured with Fluorescence Flow Cytometry
Time Frame
Change from baseline Neutrophil Lymphocyte Ratio at 4 weeks
Title
Interleukin 6
Description
Measured with Fluorescence Immunoassay
Time Frame
Change from baseline Interleukin-6 level at 4 weeks
Title
Interleukin 10
Description
Measured with ELISA
Time Frame
Change from baseline Interleukin-10 level at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cipto Mangunkusumo National Hospital
City
Jakarta
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

Music Therapy on Neutrophyl Lymphocytes Ratio, Interleukin 6 and Interleukin 10 Levels of Burnout Syndrome

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