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

Mayo Clinic40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Stress, Emotional Sleep Quality of Life

Interventions

Muse S™ Headband systemDEVICE

Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Frequency Adherence to Intervention

Summarizing frequency subjects use intervention during active study participation (during 3 month study period)

Time frame: 3 months

Duration Adherence to Intervention

Summarizing duration of time subjects use intervention during active study participation (during 3 month time period)

Time frame: 3 months

Secondary Outcomes

Perceived Stress Scale (PSS) Score Difference

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.

Time frame: 90 days

Resilience Score Difference

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

Time frame: 90 days

LASA Score Difference

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

Data from ClinicalTrials.gov

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