Music Therapy on Neutrophyl Lymphocytes Ratio, Interleuki... | NCT05750160

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

NCT05750160

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Jun 5, 2023Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Burnout Syndrome
Neutrophil-Lymphocyte Ratio
Interleukin-6
Interleukin-10

Interventions

music therapy

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2023Actual

Primary Completion Date

Feb 18, 2023Actual

Completion Date

Mar 18, 2023Actual

First Submitted Date

Jan 15, 2023

First Submission Date that Met QC Criteria

Feb 20, 2023

First Posted Date

Mar 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2023

Last Update Posted Date

Jun 5, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yovita Mulyakusuma, Principal Investigator, Indonesia UniversityPrincipal Investigator

Lead Sponsor

Indonesia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Given education only
Intervention	Experimental	Given education and music therapy	Other: music therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
music therapy	Other	Music therapy that have been made by Music Therapist after Focus Group discussion, given three times a week for 4 weeks	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cipto Mangunkusumo National Hospital		Jakarta			Indonesia

Condition Browse Module

MeSH Terms

ID	Term
D000077062	Burnout, Psychological

Ancestor Terms

ID	Term
D013315	Stress, Psychological
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009147	Music Therapy

Ancestor Terms

ID	Term
D026421	Sensory Art Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided