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

April 6, 2021 updated by: Diana J. Kelm

The Impact of the MUSE Meditation Device on Perceived Stress, Anxiety, Affect, and Burnout Among Student Registered Nurse Anesthetists

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 3, 6, and 12 months
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.
baseline and 3, 6, and 12 months
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.
baseline and 3, 6, and 12 months
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
3 & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diana J. Kelm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 20, 2019

Primary Completion (ACTUAL)

February 23, 2021

Study Completion (ACTUAL)

February 23, 2021

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (ACTUAL)

February 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-011173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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