BurnoutNCT04486898
Music Therapy on Burnout Reduction in Nurses
A study testing Music group in people with Burnout, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
This study aims to investigate the effects of music intervention in relieving burnout among nurses. Burnout is a condition of deceased job performance resulting from increased stress in the workplace.This study is to attempt to examine whether music therapy would decrease burnout symptoms and whether there would be a… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout
- What is being tested?
- Music group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 28 Nov 2020
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Licensed Registered Nurse
- 3 and more years of work experience
- Complaint of burnout syndrome
- Can speak English
- Consented
Who cannot join
- diagnosed with advanced cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Music Therapy in Relieving Burnout Among Nurses
This study aims to investigate the effects of music intervention in relieving burnout among nurses. Burnout is a condition of deceased job performance resulting from increased stress in the workplace.This study is to attempt to examine whether music therapy would decrease burnout symptoms and whether there would be a greater decrease of burnout in the music intervention group than the non-music intervention group. In this randomized controlled trial study, we will be using a convenience sample of nurses from Emergency room, medical unit, surgical unit, pediatric, ICU, labor and delivery at the Majuro hospital. Participant will be met for three session each week for a five week period. The participant will be divided into an experimental group (group A) using a music relaxation intervention and control group (group B) with usual care. The study will used the Maslach Burnout Inventory (MBI) with a pretest/post-test design measuring burnout at the beginning before the first session starts and at the end of the last session ends. We hypothesized that clinical nurses who will received music intervention will experience reduction in burnout compared with those in control group will not.
Read the detailed description
We aim to explore the potential of music therapy to support burnout among nurses and convenience sampling method will be adopted. This will be a randomized single-blinded, two-arm, parallel study, with data to be collected between August to December 2020. Eligible participants will be assigned to either music therapy group or the waiting-list control group. This study will be submitted to Leroj Atama Memorial Hospital at the Ministry of Health and Human Services and the College of the Marshall Islands Research committee for approval.We will enroll nurses from the General units of Leroj Atama Memorial Hospital in Majuro, Marshall Islands. The invitation to participate will be communicated by the Chief Nursing Officer and baseline assessment will be given by a trained study interviewer for participant recruitment. A structured questionnaire will be used to collect data on demographics, burnout, depression, stress, and anxiety. Participants will be recruited from the emergency units and 5 inpatients wards of general hospital of Leroj Atama Memorial Hospital in Majuro, Marshall Islands. We anticipate to enroll 42 nurses into this study. They will be divided into 2 group which are 21 for music group and 21 for control group.Random assignment will be performed by generating sequential numbers using computer software. The random sequential number will then be sealed in thick, opaque, consecutively numbered envelopes before data collections by an independent investigator. Patients will be allocated to either intervention or control group depending on the sequences number revealed by principal investigator. all participants in the music group will receive music intervention over five weeks. Each participant receives music intervention 30 mins per session (2 pm or 4 pm), three days in a week according to their schedule. Music intervention will be conducted at a quiet environment (i.e., nursing lounge) in the hospital. Four types of music protocols based on different rhythm or tones will provide to them, such as classical, slow music, traditional, and Christian song, before the session. Participants will listen to the songs selected and be given mp3 and earpiece for delivering the intervention. During each music session, individual will be advised to close his/her eyes and relaxed and only think of a happy memory. Participant in the waiting-list control group will be asked to maintain their daily routine and they will receive music intervention after the completion of the study.
- Conditions
- Burnout
- Being tested
- Music group
- Keywords
- nurses, music therapy,
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music groupOther
Music group will be given music intervention or listen to music for 30 minutes ,3 times a week for the period of 5 week duration. Music will be selected as per participant's preference
| Study group | Role | What they receive |
|---|---|---|
| Music group | Experimental | Music group will be receiving music intervention 3 times a day for 30 minutes per session for the duration of five (5) weeks period. Receives: Other: Music group |
| Usual care | No intervention | Those who will be in this group will be ask to continue doing their actual activities and not to partake in any kind of music listening or therapy for the 5 week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout
Burnout will be measured using Maslach Burnout Inventory questionnaire scale, 22 items subscales of the 3 domain show high consistency with Cronbach's α coefficient values of 0.837, 0.869, and 0.881 and test-retest reliability was high ( p<0.001 ). At baseline, we will collect data regarding burnout level, depression, anxiety, stress and demographic characteristic ( i.e, age, gender, marital status, and having children ect. ) that have been demonstrated to be associated with nurse burnout. The outcome indicators will be collected at 5 weeks after the completion of the intervention. Respondents in the waiting-list control group will complete self-report measures at the same time points as those in the music intervention group.
Measured: at baseline
Burnout
Burnout will be measured using Maslach Burnout Inventory questionnaire scale, 22 items subscales of the 3 domain show high consistency with Cronbach's α coefficient values of 0.837, 0.869, and 0.881 and test-retest reliability was high ( p<0.001 ). At baseline, we will collect data regarding burnout level, depression, anxiety, stress and demographic characteristic ( i.e, age, gender, marital status, and having children ect. ) that have been demonstrated to be associated with nurse burnout. The outcome indicators will be collected at 5 weeks after the completion of the intervention. Respondents in the waiting-list control group will complete self-report measures at the same time points as those in the music intervention group.
Measured: the 5th week after the treatment completion
Secondary outcomes (2)
Depression, anxiety and stress
They will be measured using a self-reported questionnaire, the 21-item Depression Anxiety Stress Score scale (DASS). It assesses the autonomic arousal, skeletal muscle effects, situational anxiety and subjective experience of anxious for anxiety scale, depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia, and stress scale assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable and impatient. Subjects are asked to use 4-point scale from 0 'do not apply to me at all' to 3 'apply to me very much' severity/frequency to rate the extent to which they have experienced each state over the past week, DASS score are calculated by summing the scores for the relevant items and 11 score or higher indicates probable presence of greater mood disorder. The subdomain score of 28 and above indicates extremely severe of depression level; the score of 20 and above reflects extremely
Measured: at baseline
Depression, anxiety and stress
They will be measured using a self-reported questionnaire, the 21-item Depression Anxiety Stress Score scale (DASS). It assesses the autonomic arousal, skeletal muscle effects, situational anxiety and subjective experience of anxious for anxiety scale, depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia, and stress scale assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable and impatient. Subjects are asked to use 4-point scale from 0 'do not apply to me at all' to 3 'apply to me very much' severity/frequency to rate the extent to which they have experienced each state over the past week, DASS score are calculated by summing the scores for the relevant items and 11 score or higher indicates probable presence of greater mood disorder. The subdomain score of 28 and above indicates extremely severe of depression level; the score of 20 and above reflects extremely
Measured: the 5th week after the treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Aug 2020
- Primary completion28 Nov 2020
- Study completion28 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnoutStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- This will be a randomized controlled trial with single-blinded, two-arm parallel study. Data will be collected between August to December 2020. A structured questionnaire will be used to collect data on demographics, burnout, depression, stress, and anxiety. We will enroll nurses from the General units of Leroj Atama Memorial Hospital in Majuro, Marshall Islands. The invitation to participate will be communicated by the Chief Nursing Officer and baseline assessment will be given by a trained study interviewer for participant recruitment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Yean Chiu, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486898
- Sponsor's protocol ID
- IRB 2020-002
- Status last verified
- Apr 2024
- First submitted
- 21 Jul 2020
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Molina-Praena J, Ramirez-Baena L, Gomez-Urquiza JL, Canadas GR, De la Fuente EI, Canadas-De la Fuente GA. Levels of Burnout and Risk Factors in Medical Area Nurses: A Meta-Analytic Study. Int J Environ Res Public Health. 2018 Dec 10;15(12):2800. doi: 10.3390/ijerph15122800.
PubMed 30544672
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Therapy in Relieving Burnout Among Nurses
- ClinicalTrials.gov ID
- NCT04486898
- Acronym / sponsor ID
- IRB 2020-002
- Conditions
- Burnout
- Keywords
- nurses, music therapy,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 28 Nov 2020 (actual)
- Study completion
- 28 Nov 2020 (actual)
- First posted
- 27 Jul 2020 (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.
This study aims to investigate the effects of music intervention in relieving burnout among nurses. Burnout is a condition of deceased job performance resulting from increased stress in the workplace.This study is to attempt to examine whether music therapy would decrease burnout symptoms and whether there would be a greater decrease of burnout in the music intervention group than the non-music intervention group. In this randomized controlled trial study, we will be using a convenience sample of nurses from Emergency room, medical unit, surgical unit, pediatric, ICU, labor and delivery at the Majuro hospital. Participant will be met for three session each week for a five week period. The participant will be divided into an experimental group (group A) using a music relaxation intervention and control group (group B) with usual care. The study will used the Maslach Burnout Inventory (MBI) with a pretest/post-test design measuring burnout at the beginning before the first session starts and at the end of the last session ends. We hypothesized that clinical nurses who will received music intervention will experience reduction in burnout compared with those in control group will not.
Detailed description
We aim to explore the potential of music therapy to support burnout among nurses and convenience sampling method will be adopted. This will be a randomized single-blinded, two-arm, parallel study, with data to be collected between August to December 2020. Eligible participants will be assigned to either music therapy group or the waiting-list control group. This study will be submitted to Leroj Atama Memorial Hospital at the Ministry of Health and Human Services and the College of the Marshall Islands Research committee for approval.We will enroll nurses from the General units of Leroj Atama Memorial Hospital in Majuro, Marshall Islands. The invitation to participate will be communicated by the Chief Nursing Officer and baseline assessment will be given by a trained study interviewer for participant recruitment. A structured questionnaire will be used to collect data on demographics, burnout, depression, stress, and anxiety. Participants will be recruited from the emergency units and 5 inpatients wards of general hospital of Leroj Atama Memorial Hospital in Majuro, Marshall Islands. We anticipate to enroll 42 nurses into this study. They will be divided into 2 group which are 21 for music group and 21 for control group.Random assignment will be performed by generating sequential numbers using computer software. The random sequential number will then be sealed in thick, opaque, consecutively numbered envelopes before data collections by an independent investigator. Patients will be allocated to either intervention or control group depending on the sequences number revealed by principal investigator. all participants in the music group will receive music intervention over five weeks. Each participant receives music intervention 30 mins per session (2 pm or 4 pm), three days in a week according to their schedule. Music intervention will be conducted at a quiet environment (i.e., nursing lounge) in the hospital. Four types of music protocols based on different rhythm or tones will provide to them, such as classical, slow music, traditional, and Christian song, before the session. Participants will listen to the songs selected and be given mp3 and earpiece for delivering the intervention. During each music session, individual will be advised to close his/her eyes and relaxed and only think of a happy memory. Participant in the waiting-list control group will be asked to maintain their daily routine and they will receive music intervention after the completion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a randomized controlled trial with single-blinded, two-arm parallel study. Data will be collected between August to December 2020. A structured questionnaire will be used to collect data on demographics, burnout, depression, stress, and anxiety. We will enroll nurses from the General units of Leroj Atama Memorial Hospital in Majuro, Marshall Islands. The invitation to participate will be communicated by the Chief Nursing Officer and baseline assessment will be given by a trained study interviewer for participant recruitment
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Other: Music groupMusic group will be receiving music intervention 3 times a day for 30 minutes per session for the duration of five (5) weeks period. |
| Usual care | No intervention | –Those who will be in this group will be ask to continue doing their actual activities and not to partake in any kind of music listening or therapy for the 5 week period. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Licensed Registered Nurse
- 3 and more years of work experience
- Complaint of burnout syndrome
- Can speak English
- Consented
Key exclusion criteria (1 listed)
- diagnosed with advanced cancer
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 |
|---|---|---|
| Music groupMusic group will be given music intervention or listen to music for 30 minutes ,3 times a week for the period of 5 week duration. Music will be selected as per participant's preference | Other | Music group |
Primary outcome
Burnout
Time frame: at baseline
Burnout will be measured using Maslach Burnout Inventory questionnaire scale, 22 items subscales of the 3 domain show high consistency with Cronbach's α coefficient values of 0.837, 0.869, and 0.881 and test-retest reliability was high ( p<0.001 ). At baseline, we will collect data regarding burnout level, depression, anxiety, stress and demographic characteristic ( i.e, age, gender, marital status, and having children ect. ) that have been demonstrated to be associated with nurse burnout. The outcome indicators will be collected at 5 weeks after the completion of the intervention. Respondents in the waiting-list control group will complete self-report measures at the same time points as those in the music intervention group.
Burnout
Time frame: the 5th week after the treatment completion
Burnout will be measured using Maslach Burnout Inventory questionnaire scale, 22 items subscales of the 3 domain show high consistency with Cronbach's α coefficient values of 0.837, 0.869, and 0.881 and test-retest reliability was high ( p<0.001 ). At baseline, we will collect data regarding burnout level, depression, anxiety, stress and demographic characteristic ( i.e, age, gender, marital status, and having children ect. ) that have been demonstrated to be associated with nurse burnout. The outcome indicators will be collected at 5 weeks after the completion of the intervention. Respondents in the waiting-list control group will complete self-report measures at the same time points as those in the music intervention group.
2 secondary outcomes
Depression, anxiety and stress
Time frame: at baseline
Depression, anxiety and stress
Time frame: the 5th week after the treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Background: PubMed 30544672Molina-Praena J, Ramirez-Baena L, Gomez-Urquiza JL, Canadas GR, De la Fuente EI, Canadas-De la Fuente GA. Levels of Burnout and Risk Factors in Medical Area Nurses: A Meta-Analytic Study. Int J Environ Res Public Health. 2018 Dec 10;15(12):2800. doi: 10.3390/ijerph15122800.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music group in people with Burnout, run by Taipei Medical University at 1 site in Taiwan.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 11 Apr 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burnout (time frame: at baseline). The study lists 2 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 NCT04486898, which also lists 1 linked publication.
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 11 Apr 2024.