The Impact of the MUSE Meditation Device on Student Registered Nurse Anesthetists (MUSE)

• ClinicalTrials.gov Identifier: NCT03839407
• Recruitment Status: Completed
• First Posted: February 15, 2019
• Last Update Posted: April 8, 2021
• Sponsor: Diana J. Kelm
• Information provided by (Responsible Party): Diana J. Kelm, Mayo Clinic

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.

Condition or disease	Intervention/treatment	Phase
Stress; Anxiety; Affect; Burnout, Professional	Device: MUSE Meditation Device	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Impact of the MUSE Meditation Device on Perceived Stress, Anxiety, Affect, and Burnout Among Student Registered Nurse Anesthetists
• Actual Study Start Date: February 20, 2019
• Actual Primary Completion Date: February 23, 2021
• Actual Study Completion Date: February 23, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: MUSE device Class 21; Participants will utilize the MUSE device for 12 weeks during the intervention period.	Device: MUSE Meditation Device; The MUSE Meditation Device guides users in mindful meditation using real-time feedback on brain wave activity.
No Intervention: No MUSE device Class 21; Participants will not utilize the MUSE device for 12 weeks during the non-intervention period.
Experimental: MUSE device Class 22; Participants will utilize the MUSE device for 12 weeks during the intervention period.	Device: MUSE Meditation Device; The MUSE Meditation Device guides users in mindful meditation using real-time feedback on brain wave activity.
No Intervention: No MUSE device Class 22; Participants will not utilize the MUSE device for 12 weeks during the non-intervention period.

Outcome Measures

Primary Outcome Measures :

1. Change in Stress, as measured by the Perceived Stress Scale-10 [ Time Frame: baseline and 3, 6, and 12 months ]
   Scores range from 0 to 40 with 0 indicating no stress and a higher score indicating greater stress.

Secondary Outcome Measures :

1. Change in Anxiety, as measured by the Generalized Anxiety Disorder Scale-7 [ Time Frame: baseline and 3, 6, and 12 months ]
   Scores range from 0 to 21 with 0 indicating no anxiety and a higher score indicating greater anxiety.
2. Change in Affect, as measured by the Positive and Negative Affect Scale [ Time Frame: baseline and 3, 6, and 12 months ]
   Scores range from 10-50 within positive and negative scales. The higher the score, the higher the positive or negative affect.
3. Change in Burnout, as measured by the Maslach Burnout Inventory-2 [ Time Frame: baseline and 3, 6, and 12 months ]
   A two question survey asking the participant burnout questions within the workplace.
4. Change in Self-Perceived Medical Error, as measured by a single question. [ Time Frame: 3 & 6 months ]
   A single yes or no question asking if participant felt they made any medical errors

Eligibility Criteria

• Ages Eligible for Study: 24 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Diana J. Kelm

Investigators

• Principal Investigator: Diana Kelm, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Diana J. Kelm, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03839407
• Other Study ID Numbers: 18-011173
• First Posted: February 15, 2019
• Last Update Posted: April 8, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Burnout, Professional; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Occupational Stress; Occupational Diseases