StressMUSENCT03839407
The Impact of the MUSE Meditation Device on Student Registered Nurse Anesthetists
A study testing MUSE Meditation Device in people with Stress and Anxiety, run by Diana J. Kelm at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 24 to 55 yearsHealthy volunteers can take part
- What is being tested?
- MUSE Meditation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2019to 23 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Student Registered Nurse Anesthetists at Mayo Clinic in the class of 2021 and 2022.
Who cannot join
- Student Registered Nurse Anesthetists at Mayo Clinic who are not in the class of 2021 and 2022.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stress, Anxiety, Affect, Burnout, Professional
- Being tested
- MUSE Meditation Device
- Medical subject headings
- Anxiety Disorders, Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUSE Meditation DeviceDevice
The MUSE Meditation Device guides users in mindful meditation using real-time feedback on brain wave activity.
| Study group | Role | What they receive |
|---|---|---|
| MUSE device Class 21 | Experimental | Participants will utilize the MUSE device for 12 weeks during the intervention period. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3, 6, and 12 months
Secondary outcomes (4)
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.
Measured: baseline and 3, 6, and 12 months
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.
Measured: baseline and 3, 6, and 12 months
Change in Burnout, as measured by the Maslach Burnout Inventory-2
A two question survey asking the participant burnout questions within the workplace.
Measured: baseline and 3, 6, and 12 months
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
Measured: 3 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start20 Feb 2019
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diana J. Kelm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diana J. Kelm, Mayo Clinic
- Investigators
- Diana Kelm, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839407
- Sponsor's protocol ID
- 18-011173
- Acronym
- MUSE
- Status last verified
- Apr 2021
- First submitted
- 11 Feb 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the MUSE Meditation Device on Perceived Stress, Anxiety, Affect, and Burnout Among Student Registered Nurse Anesthetists
- ClinicalTrials.gov ID
- NCT03839407
- Acronym / sponsor ID
- MUSE / 18-011173
- Conditions
- Stress, Anxiety, Affect, Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Diana J. KelmUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MUSE device Class 21 | Experimental | Device: MUSE Meditation DeviceParticipants will utilize the MUSE device for 12 weeks during the intervention period. |
| 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 | Device: MUSE Meditation DeviceParticipants will utilize the MUSE device for 12 weeks during the intervention period. |
| No MUSE device Class 22 | No intervention | –Participants will not utilize the MUSE device for 12 weeks during the non-intervention period. |
Who may qualify
- Ages
- 24 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Student Registered Nurse Anesthetists at Mayo Clinic in the class of 2021 and 2022.
Key exclusion criteria (1 listed)
- Student Registered Nurse Anesthetists at Mayo Clinic who are not in the class of 2021 and 2022.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MUSE Meditation DeviceThe MUSE Meditation Device guides users in mindful meditation using real-time feedback on brain wave activity. | Device | MUSE device Class 21, MUSE device Class 22 |
Primary outcome
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.
4 secondary outcomes
Change in Anxiety, as measured by the Generalized Anxiety Disorder Scale-7
Time frame: 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
Change in Burnout, as measured by the Maslach Burnout Inventory-2
Time frame: baseline and 3, 6, and 12 months
Change in Self-Perceived Medical Error, as measured by a single question.
Time frame: 3 & 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Kelm, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MUSE Meditation Device in people with Stress and Anxiety, run by Diana J. Kelm at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stress, as measured by the Perceived Stress Scale-10 (time frame: baseline and 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.