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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04738747
Other study ID # IRB00070943
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 2021
Est. completion date February 2022

Study information

Verified date January 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2022
Est. primary completion date January 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Baseline through Month 6
Primary 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) Baseline through Month 3
Primary 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) Baseline through Month 3
Primary 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) Baseline through Month 6
Primary 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) Baseline through Month 3
Primary 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) Baseline through Month 6
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