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Surgeon Resilience as Measured by Physiologic Feedback

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ClinicalTrials.gov Identifier: NCT05033379
Recruitment Status : Not yet recruiting
First Posted : September 2, 2021
Last Update Posted : September 2, 2021
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Cindy Kin, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Burnout, Professional Behavioral: Control Behavioral: Resilience coaching Not Applicable

Detailed 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, namely, 'The Whoop strap' collects heart rate and heart rate variability data. 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. If we are able to 600 participants then we will have a third group called the circadian alignment groups that will be told that sleep can be enhanced by 1) maintaining a regular sleep/wake schedule, 2) avoiding meals within two hours of bedtime, and 3) viewing bright light within 20min of waking and avoiding bright lights within 3 hours of bedtime. During the study period participants will also have the opportunity to participate in executive functioning tasks with EEG monitoring (via the Neurable wearable headset) on a voluntary basis. 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, and surgical performance as well as video and audio recordings during a simulated surgical task.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Circadian Alignment, Autonomic Control, and Physiologic Feedback on Measures of Resilience
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: Control Arm
Instruction about importance of sleep.
Behavioral: Control
Importance of sleep

Experimental: Coaching
Undergo resilience coaching
Behavioral: Resilience coaching
Arena Strive




Primary Outcome Measures :
  1. Recovery [ Time Frame: 6 months ]
    Using WHOOP algorithm, recovery will be quantified using heart rate variability and sleep, and serve as a measure of stress and resilience


Secondary Outcome Measures :
  1. Burnout [ Time Frame: 6 months ]
    The Physician Fulfillment Index is a quantitative measure of physician burnout and will be administered at baseline and at the end of the study.

  2. Health Habits [ Time Frame: 6 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Study participants will include full time clinically active trainees, attendings and PAs/NPs in the surgery, anesthesia and medicine departments.

Exclusion Criteria:

  • Exclusion criteria will be anyone who is not a trainee, attending or PA/NP in the departments of surgery, anesthesia or medicine or anyone who does not want to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05033379


Locations
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United States, California
Stanford Health Care
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
University of California, San Francisco
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Responsible Party: Cindy Kin, Assistant Professor of Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT05033379    
Other Study ID Numbers: 61917
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Burnout, Professional
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms
Occupational Stress
Occupational Diseases