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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03839407
Other study ID # 18-011173
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2019
Est. completion date February 23, 2021

Study information

Verified date April 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date February 23, 2021
Est. primary completion date February 23, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Years to 55 Years
Eligibility 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.

Study Design


Intervention

Device:
MUSE Meditation Device
The MUSE Meditation Device guides users in mindful meditation using real-time feedback on brain wave activity.

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Diana J. Kelm

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline and 3, 6, and 12 months
Secondary 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. baseline and 3, 6, and 12 months
Secondary 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. baseline and 3, 6, and 12 months
Secondary Change in Burnout, as measured by the Maslach Burnout Inventory-2 A two question survey asking the participant burnout questions within the workplace. baseline and 3, 6, and 12 months
Secondary 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 3 & 6 months
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