<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/NCT03839407</url>
  </required_header>
  <id_info>
    <org_study_id>18-011173</org_study_id>
    <nct_id>NCT03839407</nct_id>
  </id_info>
  <brief_title>The Impact of the MUSE Meditation Device on Student Registered Nurse Anesthetists</brief_title>
  <acronym>MUSE</acronym>
  <official_title>The Impact of the MUSE Meditation Device on Perceived Stress, Anxiety, Affect, and Burnout Among Student Registered Nurse Anesthetists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diana J. Kelm</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      The question this study is designed to answer is whether or not the use of a MUSE Meditation&#xD;
      Device lowers student registered nurse anesthetist's perception of stress, anxiety, and&#xD;
      burnout within the Mayo Clinic Doctorate of Nurse Anesthesia Practice Program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">February 23, 2021</completion_date>
  <primary_completion_date type="Actual">February 23, 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Stress, as measured by the Perceived Stress Scale-10</measure>
    <time_frame>baseline and 3, 6, and 12 months</time_frame>
    <description>Scores range from 0 to 40 with 0 indicating no stress and a higher score indicating greater stress.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety, as measured by the Generalized Anxiety Disorder Scale-7</measure>
    <time_frame>baseline and 3, 6, and 12 months</time_frame>
    <description>Scores range from 0 to 21 with 0 indicating no anxiety and a higher score indicating greater anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Affect, as measured by the Positive and Negative Affect Scale</measure>
    <time_frame>baseline and 3, 6, and 12 months</time_frame>
    <description>Scores range from 10-50 within positive and negative scales. The higher the score, the higher the positive or negative affect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Burnout, as measured by the Maslach Burnout Inventory-2</measure>
    <time_frame>baseline and 3, 6, and 12 months</time_frame>
    <description>A two question survey asking the participant burnout questions within the workplace.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Perceived Medical Error, as measured by a single question.</measure>
    <time_frame>3 &amp; 6 months</time_frame>
    <description>A single yes or no question asking if participant felt they made any medical errors</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Stress</condition>
  <condition>Anxiety</condition>
  <condition>Affect</condition>
  <condition>Burnout, Professional</condition>
  <arm_group>
    <arm_group_label>MUSE device Class 21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will utilize the MUSE device for 12 weeks during the intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No MUSE device Class 21</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will not utilize the MUSE device for 12 weeks during the non-intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MUSE device Class 22</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will utilize the MUSE device for 12 weeks during the intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No MUSE device Class 22</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will not utilize the MUSE device for 12 weeks during the non-intervention period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MUSE Meditation Device</intervention_name>
    <description>The MUSE Meditation Device guides users in mindful meditation using real-time feedback on brain wave activity.</description>
    <arm_group_label>MUSE device Class 21</arm_group_label>
    <arm_group_label>MUSE device Class 22</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Student Registered Nurse Anesthetists at Mayo Clinic in the class of 2021 and 2022.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Student Registered Nurse Anesthetists at Mayo Clinic who are not in the class of 2021&#xD;
             and 2022.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diana Kelm, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Diana J. Kelm</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Professional</mesh_term>
    <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/NCT03839407
org study id: 18-011173
nct id: NCT03839407
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The question this study is designed to answer is whether or not the use of a MUSE Meditation
      Device lowers student registered nurse anesthetist's perception of stress, anxiety, and
      burnout within the Mayo Clinic Doctorate of Nurse Anesthesia Practice Program.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Stress, as measured by the Perceived Stress Scale-10
time frame: baseline and 3, 6, and 12 months
description: Scores range from 0 to 40 with 0 indicating no stress and a higher score indicating greater stress.
measure: Change in Anxiety, as measured by the Generalized Anxiety Disorder Scale-7
time frame: baseline and 3, 6, and 12 months
description: Scores range from 0 to 21 with 0 indicating no anxiety and a higher score indicating greater anxiety.
measure: Change in Affect, as measured by the Positive and Negative Affect Scale
time frame: baseline and 3, 6, and 12 months
description: Scores range from 10-50 within positive and negative scales. The higher the score, the higher the positive or negative affect.
measure: Change in Burnout, as measured by the Maslach Burnout Inventory-2
time frame: baseline and 3, 6, and 12 months
description: A two question survey asking the participant burnout questions within the workplace.
measure: Change in Self-Perceived Medical Error, as measured by a single question.
time frame: 3 & 6 months
description: A single yes or no question asking if participant felt they made any medical errors
arm group label: MUSE device Class 21
arm group type: Experimental
description: Participants will utilize the MUSE device for 12 weeks during the intervention period.
arm group label: No MUSE device Class 21
arm group type: No Intervention
description: Participants will not utilize the MUSE device for 12 weeks during the non-intervention period.
arm group label: MUSE device Class 22
arm group type: Experimental
description: Participants will utilize the MUSE device for 12 weeks during the intervention period.
arm group label: No MUSE device Class 22
arm group type: No Intervention
description: Participants will not utilize the MUSE device for 12 weeks during the non-intervention period.
intervention type: Device
intervention name: MUSE Meditation Device
description: The MUSE Meditation Device guides users in mindful meditation using real-time feedback on brain wave activity.
arm group label: MUSE device Class 21
arm group label: MUSE device Class 22
criteria: 
gender: All
minimum age: 24 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Diana Kelm, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Diana J. Kelm
investigator title: Principal Investigator
mesh term: Burnout, Professional
mesh term: Burnout, Psychological
sharing ipd: No