NCT07356141

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

January 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

January 12, 2026

Last Update Submit

March 8, 2026

Conditions

Keywords

stress

Outcome Measures

Primary Outcomes (1)

  • Heart rate changes in dental students during dental procedures

    During each dental treatment session per session

Study Arms (2)

patient with special needs

Patients with capability

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Subjects - Dental Students: Ten (10) dental students enrolled at the University of Illinois Chicago (UIC) College of Dentistry will participate. These students will provide routine clinical care to both special needs and non-special needs patients as part of their standard educational and clinical responsibilities. Secondary Subjects - Patients Receiving Care: Approximately 200 patients will be observed during these clinical sessions, including both special needs patients treated in the Inclusive Care Clinic (ICC) and non-special needs patients treated in other UIC dental clinics. Special needs patients and/or their legally authorized representatives (LARs) will provide consent, and, when appropriate, patients will provide assent.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Declines consent/permission/assent or withdraws at any time.
  • Prisoners or individuals under custodial supervision.
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Chicago (UIC) College of Dentistry

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 21, 2026

Study Start

April 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations