- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04486898
Music Therapy on Burnout Reduction in Nurses
April 9, 2024 updated by: Hsiao-Yean Chiu, Taipei Medical University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 110
- Taipei Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Licensed Registered Nurse
- 3 and more years of work experience
- Complaint of burnout syndrome
- Can speak English
- Consented
Exclusion Criteria:
- diagnosed with advanced cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Music group
Music group will be receiving music intervention 3 times a day for 30 minutes per session for the duration of five (5) weeks period.
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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
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No Intervention: Usual care
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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at baseline
|
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.
|
the 5th week after the treatment completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression, anxiety and stress
Time Frame: at baseline
|
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
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at baseline
|
Depression, anxiety and stress
Time Frame: the 5th week after the treatment completion
|
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
|
the 5th week after the treatment completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
November 28, 2020
Study Completion (Actual)
November 28, 2020
Study Registration Dates
First Submitted
July 21, 2020
First Submitted That Met QC Criteria
July 24, 2020
First Posted (Actual)
July 27, 2020
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 2020-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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