NCT05750160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

February 13, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2023

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

5 days

First QC Date

January 15, 2023

Last Update Submit

June 1, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Burnout syndrome

    Maslach Burnout Inventory Human Service Survey (MBI-HSS) score

    change from baseline score at 4 weeks

  • Neutrophil Lymphocyte Ratio

    Measured with Fluorescence Flow Cytometry

    Change from baseline Neutrophil Lymphocyte Ratio at 4 weeks

  • Interleukin 6

    Measured with Fluorescence Immunoassay

    Change from baseline Interleukin-6 level at 4 weeks

  • Interleukin 10

    Measured with ELISA

    Change from baseline Interleukin-10 level at 4 weeks

Study Arms (2)

Control

NO INTERVENTION

Given education only

Intervention

EXPERIMENTAL

Given education and music therapy

Other: music therapy

Interventions

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

Intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo National Hospital

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2023

First Posted

March 1, 2023

Study Start

February 13, 2023

Primary Completion

February 18, 2023

Study Completion

March 18, 2023

Last Updated

June 5, 2023

Record last verified: 2023-06

Locations