Surgeon Resilience as Measured by Physiologic Feedback
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05033379|
Recruitment Status : Not yet recruiting
First Posted : September 2, 2021
Last Update Posted : September 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Burnout, Professional||Behavioral: Control Behavioral: Resilience coaching||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Control Arm
Instruction about importance of sleep.
Importance of sleep
Undergo resilience coaching
Behavioral: Resilience coaching
- 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
- 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.
- 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
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
|United States, California|
|Stanford Health Care|
|Stanford, California, United States, 94305|