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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05510102
Other study ID # 21D.754
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 22, 2022
Est. completion date April 1, 2023

Study information

Verified date August 2022
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A reliable method for monitoring stress and burnout among medical students is critically needed. To address this gap, our team aims to utilize the cost-effective WHOOP strap 4.0 wearable device to continuously capture stress-relevant physiologic data (i.e., sleep hours, heart rate variability, respiration rate, resting heart rate) among up to 50 third-year medical students at 24 Sidney Kimmel Medical College at Thomas Jefferson University for 6 months.


Description:

Aim 1: To determine whether physiologic metrics of sleep and heart rate variability correlate with subjective assessments of medical student wellness in a 6-month period. Hypothesis: Less total sleep hours will correlate with higher scores for Perceived Stress Scale-4, Medical Student Well-Being Index, and Patient Health Questionnaire-9, but lower heart rate variability will correlate with higher scores on Perceived Stress Scale-4, Medical Student Well Being Index, and Patient Health Questionnaire-9. Aim 2: To determine whether physiologic metrics of sleep and heart rate variability correlate with performance on shelf examinations for clinical rotations in a 6-month period. Hypothesis: Less total sleep hours and lower heart rate variability will correlate with poorer performance on shelf examinations.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date April 1, 2023
Est. primary completion date February 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Third-year medical student at Thomas Jefferson University - =18 years of age - Actively participating in family medicine, internal medicine, neurology, obstetrics/gynecology, pediatrics, psychiatry, surgery, or emergency medicine rotations - Own a smart phone for Bluetooth pairing with WHOOP strap 4.0 Exclusion Criteria: - Allergies, contraindications, or unwillingness to wear a wrist device for the study period

Study Design


Related Conditions & MeSH terms


Intervention

Device:
WHOOP strap 4.0 (full data access)
The WHOOP strap 4.0 provides continuous physiologic data via remote monitoring. Subjects will have full remote monitoring data access throughout the entirety of the study (6 months).
WHOOP strap 4.0 (partial data access)
The WHOOP strap 4.0 provides continuous physiologic data via remote monitoring. Subjects will be blinded to remote monitoring data for the first 3 months of the study followed by an unblinding and full access to remote monitoring data at the 3 month mark (continued for the remainder of the study).

Locations

Country Name City State
United States Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total sleep hours per night Sleep (hours per night) will be objectively measured nightly. 180 days
Primary Medical Student Well-Being Index (MSWBI) The MSWBI consists of 7 items, scored 0-7, with lower scores indicative of better medical student wellbeing. This survey will be administered biweekly. 180 days
Secondary REM sleep hours, nightly REM sleep hours will be measured nightly by the WHOOP strap 4.0. 180 days
Secondary Deep sleep hours, nightly Deep sleep hours will be measured nightly by the WHOOP strap 4.0. 180 days
Secondary Resting heart rate, nightly Resting heart rate will be measured nightly by the WHOOP strap 4.0. 180 days
Secondary Heart rate variability, nightly Heart rate variability will be measured nightly by the WHOOP strap 4.0. 180 days
Secondary Respiration rate, nightly Respiration rate will be measured nightly by the WHOOP strap 4.0. 180 days
Secondary Pulse oximetry, nightly Pulse oximetry will be measured nightly by the WHOOP strap 4.0. 180 days
Secondary Body temperature, nightly Body temperature will be measured nightly by the WHOOP strap 4.0. 180 days
Secondary Average duty hours per week Duty hours will be self-reported every week 180 days
Secondary Perceived Stress Scale-4 The PSS-4 consists of 4 items that assess perceived stress. The items are scored on a 4-point scale. This survey will be administered biweekly. 180 days
Secondary Patient Health Questionnaire-9 (PHQ-9) The (Patient Health Questionnaire-9) PHQ-9 consists of 9 items that assess major depressive disorder. This survey will be administered biweekly. It is scored on a 0-27 scale with 27 representing most severe depression (worse outcomes). 180 days
Secondary Scores on shelf examinations Subjects will self-report examination scores for shelf exams administered after each clinical rotation. Scores are reported on a 0-100 scale with 100 being the best score possible. 180 days
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