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Monitoring Occupational Dental Stress Using Apple Watch

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 1, 2027 → Jun 1, 2028
See other at-risk trials from University of Illinois at Chicago

Record History

  1. Notable Primary completion pushed from Jun 1, 2027 to Jun 1, 2028 Start date: Aug 1, 2026 to Aug 1, 2027 · Completion pushed from Oct 2027 to Oct 2029 · Eligibility criteria expanded, about 14 words Show 3 more changesShow less
    • Start date: Aug 1, 2026 to Aug 1, 2027
    • Completion pushed from Oct 2027 to Oct 2029
    • Eligibility criteria expanded, about 14 words
  2. Notable Primary completion pushed from May 2026 to Jun 1, 2027 Start date: Apr 1, 2026 to Aug 1, 2026 · Completion pushed from Oct 2026 to Oct 2027v3 Show 2 more changesShow less
    • Start date: Apr 1, 2026 to Aug 1, 2026
    • Completion pushed from Oct 2026 to Oct 2027
  3. Notable Start date: Feb 1, 2026 to Apr 1, 2026v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
* This study will enroll 10 dental students (primary subjects) and up to 200 patients (secondary subjects), approximately 10 special-needs and 10 non-special-needs encounters per student, totaling about 200 treatment sessions. * Students will wear an Apple Watch to continuously monitor heart rate (HR) during routine care. The Apple Watch contains built-in physiological sensors that automatically record heart rate and heart rate variability. These data are stored locally in the Apple Health app on a study-designated iPhone that is assigned for the research and handled solely by the Principal Investigator (PI). No real-time transmission or cloud-based sharing occurs during data recording. No additional apps, accounts, or third-party software are used. At designated intervals, the PI will use the health app's built-in "Export Health Data" function on the study iPhone. This function generates a ZIP file containing an export.xml file with sensor-recorded data. The PI will then upload the ZIP file from the study iPhone directly to a secure, university-approved UI Box Health Data Folder designated for the study. No research account will be set up for this purpose. * A trained observer will record start/stop timepoints of procedure phases (e.g., seating, anesthesia start, operative phase, dismissal) to align with HR signals and will document only minimal patient variables needed for analysis: behavior/cooperation score (e.g., Frankl), sedation status, and broad procedure category (e.g., preventive, restorative, surgical). * Each dental student will complete the Perceived Stress Questionnaire (PSQ) only once at the beginning of the study to stablish a baseline measure of stress. The Questionnaire takes approximately 5 minutes to complete. Students do not need to complete the PSQ for each patient encounter. Student HR data and permitted minimal patient variables will be coded and de-identified, stored securely in UI Box Health Data Folder, and analyzed to compare special-needs vs non-special-needs encounters and to evaluate associations between student HR and the listed patient factors. No additional patient identifiers or PHI will be collected beyond what is specified above.
Trial Details
NCT Number NCT07356141
Lead Sponsor University of Illinois at Chicago
Conditions Occupational Stress
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov