A Study to Asses Wellness Using a Brain Sensing Device on Physicians

Not Applicable

Completed

• Conditions: Sleep; Quality of Life; Stress, Emotional
• Interventions: Device: Muse S™ Headband system

• Registration Number: NCT04743973
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-08
• Study Start: 2021-08-15
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-01
• Results First Submitted: 2024-11-08
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Results First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Practicing Physicians	Muse S™ Headband system	Practicing physicians at Mayo Clinic caring for patients during the COVID 19 pandemic will receive the Muse S™ Headband system, and will be asked to utilize it at least 4 times per week for a minimum of 10 minutes each time over a period of 3 months (12 weeks).

Primary Outcome Measures

Name	Time	Method
Frequency Adherence to Intervention	3 months	Summarizing frequency subjects use intervention during active study participation (during 3 month study period)
Duration Adherence to Intervention	3 months	Summarizing duration of time subjects use intervention during active study participation (during 3 month time period)

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS) Score Difference	90 days	The Perceived Stress Scale (PSS) is a 10-item 5-point Likert scale that measures global life stress by assessing the degree (Never, almost never, sometimes, often and very often) to which experiences are appraised as uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater perceived stress. The score difference is the average change from Day 90 to Baseline.
Resilience Score Difference	90 days	Resilience was measured using the Connor-Davison Resilience Scale 10 (CD-RS10). This is a 10-item, 5-point likert scale, validated, scoring system. Scores can range from 0 to 40, with higher scores indicating higher resilience. The CD-RS10 is a reliable means of assessing resilience and most often used in medical and/or disaster studies. Difference from Day 90 to baseline for the resilience score
LASA Score Difference	90 days	Quality of Life was measured using the validated Linear Analogue Self-Assessment (LASA) scale. This measure is a 6-item, 11-point likert scale, validated scoring system that measure of quality of life (QOL), in which QOL is conceptualized as a multidimensional construct with five domains (physical, functional, emotional, spiritual, and social). In this measure, each domain can score 0 as the worst possible and 10 being the best possible. The total score for QoL could range from 0 to 60 with higher score indicating greater QoL. Change from Day 90 to Baseline for the LASA score

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States