NCT04486898

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2020

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

July 21, 2020

Last Update Submit

April 9, 2024

Conditions

Keywords

nurses, music therapy,

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    the 5th week after the treatment completion

Secondary Outcomes (2)

  • Depression, anxiety and stress

    at baseline

  • Depression, anxiety and stress

    the 5th week after the treatment completion

Study Arms (2)

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.

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.

Interventions

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

Music group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Licensed Registered Nurse
  • and more years of work experience
  • Complaint of burnout syndrome
  • Can speak English
  • Consented

You may not qualify if:

  • diagnosed with advanced cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 30544672BACKGROUND

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The participants and treatment provider are aware of group assignment due to the nature of biobehavioral intervention. A single-blinded design will be adopted because outcome assessors will be blinded to the group allocation and interventions employed in the two groups. The outcome assessors will not be allowed to disclose participant grouping or to discuss the details of participants. The researcher will not discuss participant-related research data with the outcome assessors.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 27, 2020

Study Start

August 1, 2020

Primary Completion

November 28, 2020

Study Completion

November 28, 2020

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations