Occupational StressNCT07356141
Monitoring Occupational Dental Stress Using Apple Watch
An observational study of Occupational Stress, run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Occupational Stress
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2027to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois Chicago (UIC) College of Dentistry
Chicago, Illinois, 60612
Shlomo Elbahary, 312-728-0400, elbahary@uic.edu
About this study
Official title: Apple Watch Assessment of Dental Stress in Special Needs Treatment
- 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
- Occupational Stress
- Keywords
- stress
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient with special needs | Not described | |
| Patients with capability | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate changes in dental students during dental procedures
Measured: During each dental treatment session per session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Aug 2027 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shlomo Elbahary, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356141
- Sponsor's protocol ID
- STUDY2025-1178
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apple Watch Assessment of Dental Stress in Special Needs Treatment
- ClinicalTrials.gov ID
- NCT07356141
- Acronym / sponsor ID
- STUDY2025-1178
- Conditions
- Occupational Stress
- Keywords
- stress
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 1 Aug 2027 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with special needs | – | – |
| Patients with capability | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart rate changes in dental students during dental procedures
Time frame: During each dental treatment session per session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Illinois Chicago (UIC) College of Dentistry
Chicago, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Stress, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate changes in dental students during dental procedures (time frame: During each dental treatment session per session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.