Clinical trial NCT04743973: A Study to Asses Wellness Using a Brain Sensing Device on Physicians
Official title: A Feasibility Study Evaluating Mindfulness-Based Intervention Assessing A Wearable Wellness Brain Sensing Device (Muse-S) in Practicing Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Emotional
Sleep
Quality of Life
Keywords: mindfulness
Wellness
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: InteraXon, Inc.
name: Cambridge Brain Sciences
First posted: 2021-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A study to asses the feasibility of physicians using a wearable brain sensing wellness device during a time of increased work load, patient volume and stressors to assess the association between duration of active state and calm state as measured by the wearable brain sensing wellness device, and quality of life (QOL), subjective stress, sleep and resilience.

Detailed description: Participants will be instructed on how to use a brain sensing device and corresponding digital application to engage in structured digital mindfulness practices daily for 3 months. Subjects will be requested to use the device and practice daily, but the amount of time and frequency daily will be to their choosing. Subjects will also complete questionnaires and cognitive based testing throughout participation.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at time of consent
* Practicing Physicians at Mayo Clinic
* Not pregnant by subject self-report at time of consent
* Have the ability to provide informed consent
* Have the ability to complete all aspects of this trial
* Have access to a smart phone or tablet device
* Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S™ system, as determined by the clinical investigators

Exclusion Criteria:

* Used an investigational drug within the past 30 days
* Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis
* Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, or stress
* An unstable medical or mental health condition as determined by the physician investigator

Primary outcomes:
measure: Frequency Adherence to Intervention
timeFrame: 3 months
measure: Duration Adherence to Intervention
timeFrame: 3 months
Secondary outcomes:
measure: Perceived Stress Scale (PSS) Score Difference
timeFrame: 90 days
measure: Resilience Score Difference
timeFrame: 90 days
measure: LASA Score Difference
timeFrame: 90 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ivana T Croghan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghosh K, Nanda S, Hurt RT, Schroeder DR, West CP, Fischer KM, Bauer BA, Fokken SC, Ganesh R, Hanson JL, Lindeen SA, Pruthi S, Croghan IT. Mindfulness Using a Wearable Brain Sensing Device for Health Care Professionals During a Pandemic: A Pilot Program. J Prim Care Community Health. 2023 Jan-Dec;14:21501319231162308. doi: 10.1177/21501319231162308.