Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07356141

Monitoring Occupational Dental Stress Using Apple Watch

Apple Watch Assessment of Dental Stress in Special Needs Treatment

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
10 (estimated)
Sponsor
University of Illinois at Chicago · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

* 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.

Conditions

Timeline

Start date
2026-04-01
Primary completion
2026-05-01
Completion
2026-10-01
First posted
2026-01-21
Last updated
2026-03-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07356141. Inclusion in this directory is not an endorsement.