NCT04743973

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

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 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 15, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
4 months until next milestone

Results Posted

Study results publicly available

December 27, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

February 3, 2021

Results QC Date

November 8, 2024

Last Update Submit

December 4, 2024

Conditions

Stress, EmotionalSleepQuality of Life

Keywords

mindfulnessWellness

Outcome Measures

Primary Outcomes (2)

  • Frequency Adherence to Intervention

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

    3 months

  • Duration Adherence to Intervention

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

    3 months

Secondary Outcomes (3)

  • Perceived Stress Scale (PSS) Score Difference

    90 days

  • Resilience Score Difference

    90 days

  • LASA Score Difference

    90 days

Study Arms (1)

Practicing Physicians

EXPERIMENTAL

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).

Device: Muse S™ Headband system

Interventions

Muse S™ Headband systemDEVICE

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

Practicing Physicians

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 36960553RESULT

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Ivana T. Croghan
Organization
Mayo Clinic
GIMRESEARCHSTUDIES@mayo.edu
507-284-2511

Study Officials

  • Ivana T Croghan, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 8, 2021

Study Start

August 15, 2021

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

December 27, 2024

Results First Posted

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)