NCT06119451

Brief Summary

The goal of this clinical trial study is to learn about the role of traditional music therapy on burnout syndrome among healthcare workers, based on psychology, neurology, immunology, and endocrinology aspects. The main questions it aims to answer are :

  1. 1.How traditional music therapy can improve psychological aspects (emotional exhaustion, depersonalisation, and personal accomplishment) among healthcare workers with burnout syndrome?
  2. 2.How traditional music therapy can improve neuroautonom aspects (heart rate variability) among healthcare workers with burnout syndrome?
  3. 3.How traditional music therapy can improve immunology aspects (IgA and T cell regulator) among healthcare workers with burnout syndrome?
  4. 4.How traditional music therapy can improve endocrinology aspects (cortisol and endorphine) among healthcare workers with burnout syndrome?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 24, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

October 24, 2023

Last Update Submit

March 7, 2024

Conditions

Keywords

burnout syndromemusic therapyhealthcare workersmaslach burnout inventoryheart rate variabilityT cell regulatorIgAcortisolendorphine

Outcome Measures

Primary Outcomes (6)

  • Maslach Burnout Inventory Human Services Survey

    an instrument developed to capture burnout for health professionals The Maslach Burnout Inventory (MBI) is a measuring tool that is generally used to assess whether you are at risk of burnout. To explain the risk of burnout, the MBI assesses three components, namely fatigue, depersonalization and self-achievement. Each statement shows a score that explains your response. Put a check mark (√) on each number that you think represents your opinion about the statement listed in the column below. 0 : never 1. : Several times a year 2. : Less than or once a month 3. : Several times a month 4. : Once a week 5: Several times a week 6 : Every day A participant can be categorized as burnout if he has an exhaustion score ≥ 24, a cynicism score ≥ 9, and a (reversed) accomplishment score ≥ 19.

    one month

  • Heart Rate Variability

    Heart rate variability (HRV) is the fluctuation in the time intervals between adjacent heartbeats. HRV indexes neurocardiac function and is generated by heart-brain interactions and dynamic non-linear autonomic nervous system (ANS) processes.

    one month

  • Immunoglobulin A level

    Evaluate Immunoglobulin A level using saliva

    one month

  • T cell regulator

    Evaluate T cell regulator level using blood

    one month

  • Cortisol

    Evaluate cortisol level on saliva

    one month

  • Endorphine

    Evaluate endorphine level on saliva

    one month

Study Arms (2)

Interventional Group

EXPERIMENTAL

Participants who will be given both educational video and traditional music therapy 3 times a week for 4 weeks in a row. This group will get Maslach Burnout Inventory, Heart Rate Variability, IgA, T cell regulator, cortisol, and endorphine score evaluated before, in the middle, right after finishing intervention, and 2 weeks after intervention.

Behavioral: Traditional Music Therapy

Control group

NO INTERVENTION

Participants who will be given only educational video. This group will get Maslach Burnout Inventory, Heart Rate Variability, IgA, T cell regulator, cortisol, and endorphine score evaluated before, in the middle, right after finishing intervention, and 2 weeks after intervention.

Interventions

Intervention using traditional music therapy as an alternative therapy for burnout syndrome

Interventional Group

Eligibility Criteria

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

You may qualify if:

  • Agreed to participate in this study by signing an informed consent sheet
  • Above 18 years old
  • Doctors or nurses working in RSUP dr Kariadi Semarang
  • MBI-HSS score show intermediate-severe burnout
  • Meet the requirements for an HRV examination
  • Have been working for minimum one year on each instalation

You may not qualify if:

  • Above 60 years old
  • Have history of chronic illness such as cancer, thyroid, and cardiovascular disease
  • Taking drugs that affect central nervous system
  • Hearing loss and disorder
  • Psychosis, anxiety,depression and any other psychological disorder
  • Pregnant women
  • Does not like music

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUP dr. Kariadi Semarang

Semarang, Central Java, 50244, Indonesia

RECRUITING

Related Publications (4)

  • de Witte M, Pinho ADS, Stams GJ, Moonen X, Bos AER, van Hooren S. Music therapy for stress reduction: a systematic review and meta-analysis. Health Psychol Rev. 2022 Mar;16(1):134-159. doi: 10.1080/17437199.2020.1846580. Epub 2020 Nov 27.

    PMID: 33176590BACKGROUND
  • Rahayu DS, Atmoko A, Muslihati M, Setyowati AJ, Mudjijanti F. Establishing Music Therapy as an Alternative to Reducing Compassion Fatigue among Health Workers. Prehosp Disaster Med. 2023 Aug;38(4):546-547. doi: 10.1017/S1049023X2300599X. Epub 2023 Jul 5.

    PMID: 37403461BACKGROUND
  • Matthew J, Mike L, Huang HC, Wang CH, Shih CY, Chen YC, Chiu HY. Effects of personalized music intervention on nurse burnout: A feasibility randomized controlled trial. Nurs Health Sci. 2022 Dec;24(4):836-844. doi: 10.1111/nhs.12984. Epub 2022 Oct 9.

    PMID: 36089738BACKGROUND
  • Kacem I, Kahloul M, El Arem S, Ayachi S, Hafsia M, Maoua M, Ben Othmane M, El Maalel O, Hmida W, Bouallague O, Ben Abdessalem K, Naija W, Mrizek N. Effects of music therapy on occupational stress and burn-out risk of operating room staff. Libyan J Med. 2020 Dec;15(1):1768024. doi: 10.1080/19932820.2020.1768024.

    PMID: 32449482BACKGROUND

MeSH Terms

Conditions

Burnout, ProfessionalBurnout, Psychological

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized control trial using pre and post test control group design¸
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2023

First Posted

November 7, 2023

Study Start

November 30, 2023

Primary Completion

April 30, 2024

Study Completion

May 31, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations