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Impact of a Wearable Fitness Tracker on Otolaryngologists' Burnout

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ClinicalTrials.gov Identifier: NCT04738747
Recruitment Status : Withdrawn (Lack of Grant)
First Posted : February 4, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
Study the impact of the WHOOP fitness tracker on burnout in attending and resident otolaryngologists

Condition or disease Intervention/treatment Phase
Burnout Stress Sleep Deprivation Wellness Behavioral: WHOOP fitness tracker Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study the impact of the WHOOP fitness tracker
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of a Wearable Fitness Tracker on Otolaryngologists' Burnout
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: Study arm (receive a WHOOP device)
Participants randomized to the WHOOP group will be given WHOOP wrist and arm bands to wear 24/7 after an orientation on their use
Behavioral: WHOOP fitness tracker
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

No Intervention: Control arm (no intervention)
The control group will not have any intervention



Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)



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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:

  • All attending and resident Otolaryngologists at Wake Forest Baptist Health

Exclusion Criteria:

  • Users of a WHOOP device currently
  • Current interns will be excluded given they do not work with the Otolaryngology team the whole year

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): NCT04738747


Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Lyndsay Madden, DO Wake Forest Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04738747    
Other Study ID Numbers: IRB00070943
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: January 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
Keywords provided by Wake Forest University Health Sciences:
Burnout
Fitness Tracker
Additional relevant MeSH terms:
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Sleep Deprivation
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders