Monitoring Occupational Dental Stress Using Apple Watch

Official title

Apple Watch Assessment of Dental Stress in Special Needs Treatment

Overview

* 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.

Primary outcome measures

• Heart rate changes in dental students during dental procedures [Time frame: During each dental treatment session per session]

Eligibility criteria

Inclusion criteria

• Students (primary subjects) inclusion criteria: After IRB approval, non-supervisory staff or research team members will invite potential participants via UIC email/listservs. Interested students will be screened confirming: (a) good academic standing and current clinical assignment, (b) routine provision of care to both special-needs and non-special needs patients during the data-collection window, (c) willingness to wear an Apple Watch during sessions and complete baseline/end PSQ, and (d) absence of medical/dermatologic conditions that would preclude safe/accurate wrist-worn monitoring. Screening and consent occur privately and outside evaluative contexts.
• Patient (secondary subjects) Inclusion criteria: Patients will be screened at the point of care when already scheduled with a participating student. A pre-visit check confirms capacity to consent (or availability of a legally authorized representative/parent/guardian). For minors and/or special needs patients, LAR permission will be obtained in addition to assent to the research. The following criteria will be considered:
• Minors and/or Special-needs patients who are scheduled for standard clinical care with a participating student during the study period may be enrolled as secondary subjects provided that their parent/guardian or legally authorized representative (LAR) grants permission during the consent process and the patient assents to the research when appropriate.
• Adult Patients with capacity who are scheduled for standard clinical care with a participating student during the study period may be enrolled as secondary subjects provided that are willing to provide informed consent.
• Willing to allow an observer and collection of minimal visit-level variables (behavior/cooperation score, sedation status, broad procedure category).
• Patients and/or their parent(s), guardian(s), or legally authorized representative(s) providing consent must be able to understand and communicate in English.

Exclusion criteria

• Students (primary subjects) Exclusion criteria:
• Not assigned to patient-care rotations during the study window.
• Known dermatologic, cardiovascular, neurologic, or other medical conditions that would interfere with safe or accurate HR monitoring or tolerability of a wrist device.
• Unwilling or unable to provide consent or follow procedures.
• Patients (secondary subjects) Exclusion criteria:
• Declines consent/permission/assent or withdraws at any time.
• Prisoners or individuals under custodial supervision.
• Pregnant women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

United States · 1 center

• University of Illinois Chicago (UIC) College of Dentistry — Chicago

Identifiers

NCT: NCT07356141 · STUDY2025-1178

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗