<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04486898</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 2020-002</org_study_id>
    <nct_id>NCT04486898</nct_id>
  </id_info>
  <brief_title>Music Therapy on Burnout Reduction in Nurses</brief_title>
  <official_title>Effect of Music Therapy in Relieving Burnout Among Nurses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate the effects of music intervention in relieving burnout among&#xD;
      nurses. Burnout is a condition of deceased job performance resulting from increased stress in&#xD;
      the workplace.This study is to attempt to examine whether music therapy would decrease&#xD;
      burnout symptoms and whether there would be a greater decrease of burnout in the music&#xD;
      intervention group than the non-music intervention group. In this randomized controlled trial&#xD;
      study, we will be using a convenience sample of nurses from Emergency room, medical unit,&#xD;
      surgical unit, pediatric, ICU, labor and delivery at the Majuro hospital. Participant will be&#xD;
      met for three session each week for a five week period. The participant will be divided into&#xD;
      an experimental group (group A) using a music relaxation intervention and control group&#xD;
      (group B) with usual care. The study will used the Maslach Burnout Inventory (MBI) with a&#xD;
      pretest/post-test design measuring burnout at the beginning before the first session starts&#xD;
      and at the end of the last session ends. We hypothesized that clinical nurses who will&#xD;
      received music intervention will experience reduction in burnout compared with those in&#xD;
      control group will not.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We aim to explore the potential of music therapy to support burnout among nurses and&#xD;
      convenience sampling method will be adopted. This will be a randomized single-blinded,&#xD;
      two-arm, parallel study, with data to be collected between August to December 2020. Eligible&#xD;
      participants will be assigned to either music therapy group or the waiting-list control&#xD;
      group. This study will be submitted to Leroj Atama Memorial Hospital at the Ministry of&#xD;
      Health and Human Services and the College of the Marshall Islands Research committee for&#xD;
      approval.We will enroll nurses from the General units of Leroj Atama Memorial Hospital in&#xD;
      Majuro, Marshall Islands. The invitation to participate will be communicated by the Chief&#xD;
      Nursing Officer and baseline assessment will be given by a trained study interviewer for&#xD;
      participant recruitment. A structured questionnaire will be used to collect data on&#xD;
      demographics, burnout, depression, stress, and anxiety. Participants will be recruited from&#xD;
      the emergency units and 5 inpatients wards of general hospital of Leroj Atama Memorial&#xD;
      Hospital in Majuro, Marshall Islands. We anticipate to enroll 42 nurses into this study. They&#xD;
      will be divided into 2 group which are 21 for music group and 21 for control group.Random&#xD;
      assignment will be performed by generating sequential numbers using computer software. The&#xD;
      random sequential number will then be sealed in thick, opaque, consecutively numbered&#xD;
      envelopes before data collections by an independent investigator. Patients will be allocated&#xD;
      to either intervention or control group depending on the sequences number revealed by&#xD;
      principal investigator. all participants in the music group will receive music intervention&#xD;
      over five weeks. Each participant receives music intervention 30 mins per session (2 pm or 4&#xD;
      pm), three days in a week according to their schedule. Music intervention will be conducted&#xD;
      at a quiet environment (i.e., nursing lounge) in the hospital. Four types of music protocols&#xD;
      based on different rhythm or tones will provide to them, such as classical, slow music,&#xD;
      traditional, and Christian song, before the session. Participants will listen to the songs&#xD;
      selected and be given mp3 and earpiece for delivering the intervention. During each music&#xD;
      session, individual will be advised to close his/her eyes and relaxed and only think of a&#xD;
      happy memory. Participant in the waiting-list control group will be asked to maintain their&#xD;
      daily routine and they will receive music intervention after the completion of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">November 28, 2020</completion_date>
  <primary_completion_date type="Actual">November 28, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Burnout</measure>
    <time_frame>at baseline</time_frame>
    <description>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&lt;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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Burnout</measure>
    <time_frame>the 5th week after the treatment completion</time_frame>
    <description>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&lt;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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression, anxiety and stress</measure>
    <time_frame>at baseline</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression, anxiety and stress</measure>
    <time_frame>the 5th week after the treatment completion</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Burnout</condition>
  <arm_group>
    <arm_group_label>Music group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Music group will be receiving music intervention 3 times a day for 30 minutes per session for the duration of five (5) weeks period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music group</intervention_name>
    <description>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</description>
    <arm_group_label>Music group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Licensed Registered Nurse&#xD;
&#xD;
          -  3 and more years of work experience&#xD;
&#xD;
          -  Complaint of burnout syndrome&#xD;
&#xD;
          -  Can speak English&#xD;
&#xD;
          -  Consented&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosed with advanced cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Taipei Medical University</name>
      <address>
        <city>Taipei</city>
        <zip>110</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>30544672</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>January 30, 2022</last_update_submitted>
  <last_update_submitted_qc>January 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University</investigator_affiliation>
    <investigator_full_name>Hsiao-Yean Chiu</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>nurses, music therapy,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04486898
org study id: IRB 2020-002
nct id: NCT04486898
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: 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.
measure: Burnout
time frame: at baseline
description: 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.
measure: Burnout
time frame: the 5th week after the treatment completion
description: 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.
measure: Depression, anxiety and stress
time frame: at baseline
description: 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
measure: Depression, anxiety and stress
time frame: the 5th week after the treatment completion
description: 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
arm group label: Music group
arm group type: Experimental
description: Music group will be receiving music intervention 3 times a day for 30 minutes per session for the duration of five (5) weeks period.
arm group label: Usual care
arm group type: No Intervention
description: 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.
intervention type: Other
intervention name: Music group
description: 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
arm group label: Music group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
citation: 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: 30544672
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University
investigator full name: Hsiao-Yean Chiu
investigator title: Associate Professor
mesh term: Burnout, Psychological
sharing ipd: No