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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05033379
Other study ID # 61917
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date March 1, 2023

Study information

Verified date April 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Reliably achieving peak performance requires balancing the strain of the prior day with sufficient recovery to be ready for the next day. Surgery has a long standing tradition long hours of hard work often at the expense of adequate sleep. Decreased sleep and recovery has physiologic consequences which can be measured using biometric data. The goal of this study is to quantify surgeon performance and biometric data to understand how modifiable behaviors including mindfulness training and diet can maximize recovery and performance. The goal of this study is to quantify the impact if modifiable daily behaviors including sleep, nutrition, in order to understand the factors that contribute to high level performance, burnout, and physician wellbeing in surgical trainees and attendings.


Description:

Informed consent will be obtained prior to participation in the research study. A member of the research team will provide the participant with the consent form and allow them adequate time to read and ask questions prior to giving consent. If consent is not obtained, the participant will not be allowed to participate in the research study. Participants will be asked to wear a biometric sensor for six months. The biometric sensor (The WHOOP strap) collects heart rate, heart rate variability, activity, and sleep metrics. Half of the participants will complete coaching to improve resilience with Arena Strive and half will be a control group instructed that sleep is important. In the latter 3 months of the study, the control group will have the opportunity to wear a continuous glucose monitor. At the completion of the study period all participants will have access to Arena strive coaching. Other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, glucose levels using continuous glucose monitoring, exercise and mindfulness.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 400
Est. completion date March 1, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Study participants will include full time clinically active healthcare workers Exclusion Criteria: - Exclusion criteria will be anyone who is not a full-time clinical healthcare worker

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Control
Importance of sleep
Resilience coaching
Arena Strive

Locations

Country Name City State
United States Stanford Health Care Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recovery Using WHOOP algorithm, recovery will be quantified using heart rate variability and sleep, and serve as a measure of stress and resilience 6 months
Secondary Burnout The Physician Fulfillment Index is a quantitative measure of physician burnout and will be administered at baseline and at the end of the study. 6 months
Secondary Health Habits Changes in sleep metrics (duration of sleep, quality of sleep, and pre-sleep habits including light exposure and eating habits before sleep) and diet habits (evaluated by dietary pattern, ie, traditional Westernized, healthy Mediterranean, unhealthy - animal protein and alcohol, at beginning and end of the study) will be assessed 6 months
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