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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06119451
Other study ID # YArdani
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 30, 2023
Est. completion date May 31, 2024

Study information

Verified date March 2024
Source Indonesia University
Contact Yanuar Ardani
Phone +62811296486
Email dr.yanuardani@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

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


Description:

The goal of this clinical trial is to learn about the role of traditional music therapy on burnout syndrome among healthcare workers. The investigators will collected about 80 participants, which eventually get divided into intervention (40 participants) and control (40 participants) group. Participants will get examined using Maslach Burnout Inventory-Human Service Survey for rating their burnout sydnrome. Before starting the intervention, both group will get assessed for their heart rate variability, IgA and T cell regulator level, and cortisol and endorphine level. After that, Intervention group will get traditional music therapy and educational video 3 session a week for about 4 weeks. And control group will only get educational video. Both group will be assessed for their heart rate variability and their laboratory markers three times, 2 weeks after starting the intervention, right after finishing all intervention session on week 4, and 2 weeks after the intervention is done. Investigators will compare the results between control group (educational video only without any music therapy) and intervention group (traditional music therapy and educational video) to see if there are any role of traditional music therapy on burnout syndrome based on psychology-neuroautonom-immunology-endocrinology aspects.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date May 31, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Traditional Music Therapy
Intervention using traditional music therapy as an alternative therapy for burnout syndrome

Locations

Country Name City State
Indonesia RSUP dr. Kariadi Semarang Semarang Jawa Tengah

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 (v) on each number that you think represents your opinion about the statement listed in the column below.
0 : never
: Several times a year
: Less than or once a month
: Several times a month
: 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
Primary 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
Primary Immunoglobulin A level Evaluate Immunoglobulin A level using saliva one month
Primary T cell regulator Evaluate T cell regulator level using blood one month
Primary Cortisol Evaluate cortisol level on saliva one month
Primary Endorphine Evaluate endorphine level on saliva one month
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