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

• Sponsor: Diana J. Kelm (Other)
• Overall Status: Completed
• CT.gov ID: NCT03839407
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 4
• Actual Duration (Months): 24.1
• Patients Per Site Per Month: 1.4

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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: Feb 20, 2019
• Actual Primary Completion Date: Feb 23, 2021
• Actual Study Completion Date: Feb 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 [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 [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 [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 [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. [3 & 6 months]

   A single yes or no question asking if participant felt they made any medical errors

Eligibility Criteria

Criteria

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

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

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Diana J. Kelm

Investigators

• Principal Investigator: Diana Kelm, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Diana J. Kelm, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03839407
• Other Study ID Numbers: 18-011173
• First Posted: Feb 15, 2019
• Last Update Posted: Apr 8, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Apr 8, 2021