Burnout, ProfessionalERASNCT05029674
Understanding Performance: Enhancing Recovery as Surgeons
An observational study of Burnout, Professional, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Whoop
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Surgical trainees and attendings at Stanford Health Care
Who may be able to join
- Study participants will include trainee and attending surgeons
Who cannot join
- Exclusion criteria will be anyone who is not full-time clinically active as a surgical trainee or attending
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Biometric Data to Understand Surgeon Performance, Strain, and Recovery
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 can maximize recovery and performance.
Read the detailed description
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.
Other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, exercise and mindfulness, and surgical performance as well as video and audio recordings during a simulated surgical task.
Surveys will be individually numbered and a master list of subject number and video, audio, and sensor ID will be kept in a separate location. This practice will enable us to better understand survey feedback by reviewing relevant videos, images, and sensor recordings. Images and data associated with a subject will be labeled with the subject number only.
- Conditions
- Burnout, Professional
- Being tested
- Whoop
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WhoopDevice
Wear WHOOP Strap, complete surveys
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon Recovery
A daily Recovery score from 0-100% (0-33% is poor recovery, 34-66% is medium recovery, 67-100% is good recovery) is calculated using the WHOOP algorithm which takes resting heart rate, heart rate variability, and sleep metrics into account.
Measured: 6-12 months
Secondary outcomes (1)
Clinical Strain
Strain scores are calculated using the WHOOP algorithm which uses heart rate, activity, and duration of activity. The Clinical Strain will refer to the Strain calculated by the WHOOP strap that occurs during clinical activities including overnight call and operative cases.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start20 Mar 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy Kin, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029674
- Sponsor's protocol ID
- 58625
- Acronym
- ERAS
- Status last verified
- Mar 2024
- First submitted
- 17 Aug 2021
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Biometric Data to Understand Surgeon Performance, Strain, and Recovery
- ClinicalTrials.gov ID
- NCT05029674
- Acronym / sponsor ID
- ERAS / 58625
- Conditions
- Burnout, Professional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 can maximize recovery and performance.
Detailed description
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.
Other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, exercise and mindfulness, and surgical performance as well as video and audio recordings during a simulated surgical task.
Surveys will be individually numbered and a master list of subject number and video, audio, and sensor ID will be kept in a separate location. This practice will enable us to better understand survey feedback by reviewing relevant videos, images, and sensor recordings. Images and data associated with a subject will be labeled with the subject number only.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical trainees and attendings at Stanford Health Care
Key inclusion criteria (1 listed)
- Study participants will include trainee and attending surgeons
Key exclusion criteria (1 listed)
- Exclusion criteria will be anyone who is not full-time clinically active as a surgical trainee or attending
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WhoopWear WHOOP Strap, complete surveys | Device | – |
Primary outcome
Surgeon Recovery
Time frame: 6-12 months
A daily Recovery score from 0-100% (0-33% is poor recovery, 34-66% is medium recovery, 67-100% is good recovery) is calculated using the WHOOP algorithm which takes resting heart rate, heart rate variability, and sleep metrics into account.
1 secondary outcome
Clinical Strain
Time frame: 6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burnout, Professional, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon Recovery (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.