Burnout, ProfessionalNCT06119451
The Role of Traditional Music Therapy on Burnout Syndrome Among Healthcare Workers: Psycho-Neuro-Immuno-Endocrine Aspects
A study testing Traditional Music Therapy in people with Burnout, Professional, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Traditional Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Nov 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSUP dr. Kariadi Semarang
Semarang, Central Java, 50244
About this study
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 :
- How traditional music therapy can improve psychological aspects (emotional exhaustion, depersonalisation, and personal accomplishment) among healthcare workers with burnout syndrome?
- How traditional music therapy can improve neuroautonom aspects (heart rate variability) among healthcare workers with burnout syndrome?
- How traditional music therapy can improve immunology aspects (IgA and T cell regulator) among healthcare workers with burnout syndrome?
- How traditional music therapy can improve endocrinology aspects (cortisol and endorphine) among healthcare workers with burnout syndrome?
Read the detailed 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.
- Conditions
- Burnout, Professional
- Being tested
- Traditional Music Therapy
- Keywords
- burnout syndrome, music therapy, healthcare workers, maslach burnout inventory, heart rate variability, T cell regulator, IgA, cortisol, endorphine
- Medical subject headings
- Burnout, Professional, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Music TherapyBehavioural
Intervention using traditional music therapy as an alternative therapy for burnout syndrome
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- : 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.
Measured: 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.
Measured: one month
Immunoglobulin A level
Evaluate Immunoglobulin A level using saliva
Measured: one month
T cell regulator
Evaluate T cell regulator level using blood
Measured: one month
Cortisol
Evaluate cortisol level on saliva
Measured: one month
Endorphine
Evaluate endorphine level on saliva
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start30 Nov 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial using pre and post test control group design¸
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanuar Ardani, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119451
- Sponsor's protocol ID
- YArdani
- Status last verified
- Mar 2024
- First submitted
- 24 Oct 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33176590Rahayu 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.
PubMed 37403461Matthew 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.
PubMed 36089738Kacem 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.
PubMed 32449482
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Traditional Music Therapy on Burnout Syndrome Among Healthcare Workers: Psycho-Neuro-Immuno-Endocrine Aspects
- ClinicalTrials.gov ID
- NCT06119451
- Acronym / sponsor ID
- YArdani
- Conditions
- Burnout, Professional
- Keywords
- burnout syndrome, music therapy, healthcare workers, maslach burnout inventory, heart rate variability, T cell regulator, IgA, cortisol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- How traditional music therapy can improve psychological aspects (emotional exhaustion, depersonalisation, and personal accomplishment) among healthcare workers with burnout syndrome?
- How traditional music therapy can improve neuroautonom aspects (heart rate variability) among healthcare workers with burnout syndrome?
- How traditional music therapy can improve immunology aspects (IgA and T cell regulator) among healthcare workers with burnout syndrome?
- How traditional music therapy can improve endocrinology aspects (cortisol and endorphine) among healthcare workers with burnout syndrome?
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized control trial using pre and post test control group design¸
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Behavioral: Traditional Music TherapyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Music TherapyIntervention using traditional music therapy as an alternative therapy for burnout syndrome | Behavioural | Interventional Group |
Primary outcome
Maslach Burnout Inventory Human Services Survey
Time frame: one month
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.
Heart Rate Variability
Time frame: one month
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.
Immunoglobulin A level
Time frame: one month
Evaluate Immunoglobulin A level using saliva
T cell regulator
Time frame: one month
Evaluate T cell regulator level using blood
Cortisol
Time frame: one month
Evaluate cortisol level on saliva
Endorphine
Time frame: one month
Evaluate endorphine level on saliva
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 33176590de 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.
- Background: PubMed 37403461Rahayu 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.
- Background: PubMed 36089738Matthew 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.
- Background: PubMed 32449482Kacem 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Music Therapy in people with Burnout, Professional, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanuar Ardani (+62811296486, dr.yanuardani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maslach Burnout Inventory Human Services Survey (time frame: one month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06119451, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.