Back to resultsThe Impact of the MUSE Meditation Device on Student Registered Nurse Anesthetists (MUSE)
Primary Purpose
Stress, Anxiety, Affect
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MUSE Meditation Device
Sponsored by
About this trial
This is an interventional supportive care trial for Stress
Eligibility Criteria
Inclusion Criteria:
- Student Registered Nurse Anesthetists at Mayo Clinic in the class of 2021 and 2022.
Exclusion Criteria:
- Student Registered Nurse Anesthetists at Mayo Clinic who are not in the class of 2021 and 2022.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
MUSE device Class 21
No MUSE device Class 21
MUSE device Class 22
No MUSE device Class 22
Arm Description
Participants will utilize the MUSE device for 12 weeks during the intervention period.
Participants will not utilize the MUSE device for 12 weeks during the non-intervention period.
Participants will utilize the MUSE device for 12 weeks during the intervention period.
Participants will not utilize the MUSE device for 12 weeks during the non-intervention period.
Outcomes
Primary Outcome Measures
Change in Stress, as measured by the Perceived Stress Scale-10
Scores range from 0 to 40 with 0 indicating no stress and a higher score indicating greater stress.
Secondary Outcome Measures
Change in Anxiety, as measured by the Generalized Anxiety Disorder Scale-7
Scores range from 0 to 21 with 0 indicating no anxiety and a higher score indicating greater anxiety.
Change in Affect, as measured by the Positive and Negative Affect Scale
Scores range from 10-50 within positive and negative scales. The higher the score, the higher the positive or negative affect.
Change in Burnout, as measured by the Maslach Burnout Inventory-2
A two question survey asking the participant burnout questions within the workplace.
Change in Self-Perceived Medical Error, as measured by a single question.
A single yes or no question asking if participant felt they made any medical errors
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03839407
Brief Title
The Impact of the MUSE Meditation Device on Student Registered Nurse Anesthetists
Acronym
MUSE
Official Title
The Impact of the MUSE Meditation Device on Perceived Stress, Anxiety, Affect, and Burnout Among Student Registered Nurse Anesthetists
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
February 23, 2021 (Actual)
Study Completion Date
February 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Diana J. Kelm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety, Affect, Burnout, Professional
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MUSE device Class 21
Arm Type
Experimental
Arm Description
Participants will utilize the MUSE device for 12 weeks during the intervention period.
Arm Title
No MUSE device Class 21
Arm Type
No Intervention
Arm Description
Participants will not utilize the MUSE device for 12 weeks during the non-intervention period.
Arm Title
MUSE device Class 22
Arm Type
Experimental
Arm Description
Participants will utilize the MUSE device for 12 weeks during the intervention period.
Arm Title
No MUSE device Class 22
Arm Type
No Intervention
Arm Description
Participants will not utilize the MUSE device for 12 weeks during the non-intervention period.
Intervention Type
Device
Intervention Name(s)
MUSE Meditation Device
Intervention Description
The MUSE Meditation Device guides users in mindful meditation using real-time feedback on brain wave activity.
Primary Outcome Measure Information:
Title
Change in Stress, as measured by the Perceived Stress Scale-10
Description
Scores range from 0 to 40 with 0 indicating no stress and a higher score indicating greater stress.
Time Frame
baseline and 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Change in Anxiety, as measured by the Generalized Anxiety Disorder Scale-7
Description
Scores range from 0 to 21 with 0 indicating no anxiety and a higher score indicating greater anxiety.
Time Frame
baseline and 3, 6, and 12 months
Title
Change in Affect, as measured by the Positive and Negative Affect Scale
Description
Scores range from 10-50 within positive and negative scales. The higher the score, the higher the positive or negative affect.
Time Frame
baseline and 3, 6, and 12 months
Title
Change in Burnout, as measured by the Maslach Burnout Inventory-2
Description
A two question survey asking the participant burnout questions within the workplace.
Time Frame
baseline and 3, 6, and 12 months
Title
Change in Self-Perceived Medical Error, as measured by a single question.
Description
A single yes or no question asking if participant felt they made any medical errors
Time Frame
3 & 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Student Registered Nurse Anesthetists at Mayo Clinic in the class of 2021 and 2022.
Exclusion Criteria:
Student Registered Nurse Anesthetists at Mayo Clinic who are not in the class of 2021 and 2022.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Kelm, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
The Impact of the MUSE Meditation Device on Student Registered Nurse Anesthetists
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