BurnoutNCT04738747
Impact of a Wearable Fitness Tracker on Otolaryngologists' Burnout
A study testing WHOOP fitness tracker in people with Burnout and Stress, run by Wake Forest University Health Sciences.
Trial summary
Study the impact of the WHOOP fitness tracker on burnout in attending and resident otolaryngologists Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Stress, Sleep Deprivation
- What is being tested?
- WHOOP fitness tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Feb 2022
- Phase
- Interventional
- 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
Who may be able to join
- All attending and resident Otolaryngologists at Wake Forest Baptist Health
Who cannot join
- Users of a WHOOP device currently
- Current interns will be excluded given they do not work with the Otolaryngology team the whole year
About this study
Study the impact of the WHOOP fitness tracker on burnout in attending and resident otolaryngologists
Read the detailed description
The study will be a randomized controlled trial of attending and resident otolaryngologists who will be randomized to either wearing a WHOOP fitness tracker or a control group. Participants will take two Maslach burnout inventory (MBI) surveys prior to the start of the intervention to set a baseline burnout score, and then at 3 months and 6 months into the study. Baseline cardiac status will also be established by taking a pre-intervention heart rate and blood pressure.
- Conditions
- Burnout, Stress, Sleep Deprivation, Wellness
- Being tested
- WHOOP fitness tracker
- Keywords
- Burnout, Fitness Tracker
- Medical subject headings
- Burnout, Psychological, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHOOP fitness trackerBehavioural
WHOOP is a device that uses a wristband or arm band to track heart rate, heart rate variability (HRV), and sleep to calculate proprietary strain and recovery scores for its users. Heart rate variability is an important metric for correlation with acute stress
| Study group | Role | What they receive |
|---|---|---|
| Study arm (receive a WHOOP device) | Experimental | Participants randomized to the WHOOP group will be given WHOOP wrist and arm bands to wear 24/7 after an orientation on their use Receives: Behavioral: WHOOP fitness tracker |
| Control arm (no intervention) | No intervention | The control group will not have any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maslach Burnout Inventory (MBI) Scores - emotional exhaustion
MBI items are scored using a 7 level frequency ratings from "never" to "daily" - emotional exhaustion (9 items) - Higher scores indicate higher burnout (worse) than lower scores (better)
Measured: Baseline through Month 6
Change in Maslach Burnout Inventory (MBI) Scores - emotional exhaustion
MBI items are scored using a 7 level frequency ratings from "never" to "daily" - emotional exhaustion (9 items) - Higher scores indicate higher burnout (worse) than lower scores (better)
Measured: Baseline through Month 3
Change in Maslach Burnout Inventory (MBI) Scores - depersonalization
MBI items are scored using a 7 level frequency ratings from "never" to "daily" - depersonalization (5 items) - Higher scores indicate higher burnout (worse) than lower scores (better)
Measured: Baseline through Month 3
Change in Maslach Burnout Inventory (MBI) Scores - depersonalization
MBI items are scored using a 7 level frequency ratings from "never" to "daily" - depersonalization (5 items) - Higher scores indicate higher burnout (worse) than lower scores (better)
Measured: Baseline through Month 6
Change in Maslach Burnout Inventory (MBI) Scores - personal achievement
MBI items are scored using a 7 level frequency ratings from "never" to "daily" - personal achievement (8 items) - Higher scores indicate higher burnout (worse) than lower scores (better)
Measured: Baseline through Month 3
Change in Maslach Burnout Inventory (MBI) Scores - personal achievement
MBI items are scored using a 7 level frequency ratings from "never" to "daily" - personal achievement (8 items) - Higher scores indicate higher burnout (worse) than lower scores (better)
Measured: Baseline through Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study startJul 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: Lack of Grant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study the impact of the WHOOP fitness tracker
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lyndsay Madden, DO, Principal investigator, Wake Forest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738747
- Sponsor's protocol ID
- IRB00070943
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2021
- Last updated
- 2 Aug 2021
- 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 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Wearable Fitness Tracker on Otolaryngologists' Burnout
- ClinicalTrials.gov ID
- NCT04738747
- Acronym / sponsor ID
- IRB00070943
- Conditions
- Burnout, Stress, Sleep Deprivation, Wellness
- Keywords
- Burnout, Fitness Tracker
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Grant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 4 Feb 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.
Study the impact of the WHOOP fitness tracker on burnout in attending and resident otolaryngologists
Detailed description
The study will be a randomized controlled trial of attending and resident otolaryngologists who will be randomized to either wearing a WHOOP fitness tracker or a control group. Participants will take two Maslach burnout inventory (MBI) surveys prior to the start of the intervention to set a baseline burnout score, and then at 3 months and 6 months into the study. Baseline cardiac status will also be established by taking a pre-intervention heart rate and blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study the impact of the WHOOP fitness tracker
| Arm | Type | Receives |
|---|---|---|
| Study arm (receive a WHOOP device) | Experimental | Behavioral: WHOOP fitness trackerParticipants randomized to the WHOOP group will be given WHOOP wrist and arm bands to wear 24/7 after an orientation on their use |
| Control arm (no intervention) | No intervention | –The control group will not have any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All attending and resident Otolaryngologists at Wake Forest Baptist Health
Key exclusion criteria (2 listed)
- Users of a WHOOP device currently
- Current interns will be excluded given they do not work with the Otolaryngology team the whole year
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 |
|---|---|---|
| WHOOP fitness trackerWHOOP is a device that uses a wristband or arm band to track heart rate, heart rate variability (HRV), and sleep to calculate proprietary strain and recovery scores for its users. Heart rate variability is an important metric for correlation with acute stress | Behavioural | Study arm (receive a WHOOP device) |
Primary outcome
Change in Maslach Burnout Inventory (MBI) Scores - emotional exhaustion
Time frame: Baseline through Month 6
MBI items are scored using a 7 level frequency ratings from "never" to "daily" - emotional exhaustion (9 items) - Higher scores indicate higher burnout (worse) than lower scores (better)
Change in Maslach Burnout Inventory (MBI) Scores - emotional exhaustion
Time frame: Baseline through Month 3
MBI items are scored using a 7 level frequency ratings from "never" to "daily" - emotional exhaustion (9 items) - Higher scores indicate higher burnout (worse) than lower scores (better)
Change in Maslach Burnout Inventory (MBI) Scores - depersonalization
Time frame: Baseline through Month 3
MBI items are scored using a 7 level frequency ratings from "never" to "daily" - depersonalization (5 items) - Higher scores indicate higher burnout (worse) than lower scores (better)
Change in Maslach Burnout Inventory (MBI) Scores - depersonalization
Time frame: Baseline through Month 6
MBI items are scored using a 7 level frequency ratings from "never" to "daily" - depersonalization (5 items) - Higher scores indicate higher burnout (worse) than lower scores (better)
Change in Maslach Burnout Inventory (MBI) Scores - personal achievement
Time frame: Baseline through Month 3
MBI items are scored using a 7 level frequency ratings from "never" to "daily" - personal achievement (8 items) - Higher scores indicate higher burnout (worse) than lower scores (better)
Change in Maslach Burnout Inventory (MBI) Scores - personal achievement
Time frame: Baseline through Month 6
MBI items are scored using a 7 level frequency ratings from "never" to "daily" - personal achievement (8 items) - Higher scores indicate higher burnout (worse) than lower scores (better)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- 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.
Lyndsay Madden, DO principal investigator
Wake Forest Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing WHOOP fitness tracker in people with Burnout and Stress, run by Wake Forest University Health Sciences.
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 2 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: withdrawn, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Maslach Burnout Inventory (MBI) Scores - emotional exhaustion (time frame: Baseline through Month 6). The study lists 6 primary outcomes in all. 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 2 Aug 2021.