- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04738747
Impact of a Wearable Fitness Tracker on Otolaryngologists' Burnout
July 29, 2021 updated by: Wake Forest University Health Sciences
Study the impact of the WHOOP fitness tracker on burnout in attending and resident otolaryngologists
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Baseline through Month 6
|
|
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)
|
Baseline through Month 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)
|
Baseline through Month 3
|
|
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)
|
Baseline through Month 6
|
|
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)
|
Baseline through Month 3
|
|
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)
|
Baseline through Month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lyndsay Madden, DO, Wake Forest Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2021
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
February 1, 2022
Study Registration Dates
First Submitted
January 29, 2021
First Submitted That Met QC Criteria
January 29, 2021
First Posted (Actual)
February 4, 2021
Study Record Updates
Last Update Posted (Actual)
August 2, 2021
Last Update Submitted That Met QC Criteria
July 29, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00070943
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
Center for Advanced Facial Plastic SurgeryCompletedStress | Stress, Physiological | Stress Response | Stress (Psychology) | Healthy Adult Female Participants | Stress, Psychologic | Stress Perception | Stress Levels | Stress, Psychological CumulativeUnited States
-
Amsterdam UMC, location VUmcRigshospitalet, Denmark; Universitätsklinikum Hamburg-EppendorfNot yet recruitingStress | Stress and Burnout | Stress BiomarkersGermany, Denmark
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...CompletedStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
Amasya UniversityCompletedThe Effect of Online Stress Management Program on Nurses' Individual Workload Perception, and StressStress | Nursing | Stress ManagementTurkey (Türkiye)
-
Canterbury Christ Church UniversitySussex Partnership NHS Foundation TrustEnrolling by invitationOccupational Stress or Workplace StressUnited Kingdom
-
University of PadovaCompletedStress | Stress Disorder | Work Related StressItaly
-
University of Thi-QarCompletedPsychological Stress | Academic StressIraq
-
University of North Carolina, Chapel HillWashington University School of Medicine; United States Department of Defense; University of Florida and other collaboratorsRecruitingPost-traumatic Stress Disorder | Acute Stress Disorder | Acute Stress ReactionUnited States
-
Dana-Farber Cancer InstituteCompletedStress | Post Traumatic Stress Disorder | Work Related StressUnited States
Clinical Trials on WHOOP fitness tracker
-
Mike O'Callaghan Military HospitalCompletedType II Diabetes MellitusUnited States
-
Virginia Commonwealth UniversityCystic Fibrosis FoundationWithdrawn
-
University Hospital TuebingenUnknownCancer | Fatigue | Physical ActivityGermany
-
University of LimerickCompletedCystic FibrosisIreland
-
Colorado State UniversityCompleted
-
Columbia UniversityCompletedCongenital Abnormalities | Telerehabilitation | Orthotopic Heart Transplant | Cardiac Rehabilitation | Pediatric Cardiology | Telehealth | Pulmonary Arterial Hypertension (PAH)United States
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)CompletedOvarian CancerUnited States
-
Cedars-Sinai Medical CenterActive, not recruitingNeoplasms | Cancer | Cancer, MetastaticUnited States
-
HagaZiekenhuisDelft University of TechnologyEnrolling by invitationAtrial Fibrillation | Heart Failure, SystolicNetherlands
-
University Hospital of North NorwayNorwegian University of Science and Technology; St. Olavs Hospital; Laval University and other collaboratorsCompletedPhysical Activity Promotion Among Inactive AdultsNorway