NCT03839407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

February 20, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

February 11, 2019

Last Update Submit

April 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Anxiety, as measured by the Generalized Anxiety Disorder Scale-7

    baseline and 3, 6, and 12 months

  • Change in Affect, as measured by the Positive and Negative Affect Scale

    baseline and 3, 6, and 12 months

  • Change in Burnout, as measured by the Maslach Burnout Inventory-2

    baseline and 3, 6, and 12 months

  • Change in Self-Perceived Medical Error, as measured by a single question.

    3 & 6 months

Study Arms (4)

MUSE device Class 21

EXPERIMENTAL

Participants will utilize the MUSE device for 12 weeks during the intervention period.

Device: MUSE Meditation Device

No MUSE device Class 21

NO INTERVENTION

Participants will not utilize the MUSE device for 12 weeks during the non-intervention period.

MUSE device Class 22

EXPERIMENTAL

Participants will utilize the MUSE device for 12 weeks during the intervention period.

Device: MUSE Meditation Device

No MUSE device Class 22

NO INTERVENTION

Participants will not utilize the MUSE device for 12 weeks during the non-intervention period.

Interventions

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

MUSE device Class 21MUSE device Class 22

Eligibility Criteria

Age24 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Student Registered Nurse Anesthetists at Mayo Clinic in the class of 2021 and 2022.

You may not qualify if:

  • Student Registered Nurse Anesthetists at Mayo Clinic who are not in the class of 2021 and 2022.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Anxiety DisordersBurnout, Professional

Condition Hierarchy (Ancestors)

Mental DisordersOccupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Diana Kelm, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 15, 2019

Study Start

February 20, 2019

Primary Completion

February 23, 2021

Study Completion

February 23, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations