Occupational StressNCT07498348
Apple Watch Evaluation of Endodontics Occupational Stress
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 approximately 12 endodontists (primary subjects) and approximately 120 patients (secondary subjects) undergoing routine endodontic treatment (primary root canal treatment or retreatment), resulting in approximately 120 observed treatment sessions. 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2027to 15 Jun 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: A total of approximately 132 subjects will be enrolled in this study, consisting of approximately 12 endodontics (primary subjects) and approximately 120 patients (secondary subjects). Each participating endodontics will be observed during approximately 10 endodontic treatment sessions, resulting in an estimated total of 120 clinical sessions for data collection. Each patient will participate in one clinical encounter only, while resident participation will continue throughout the data collection period.
Who may be able to join
- Scheduled to receive standard endodontic care with a participating endodontics resident during the study period
- Willingness to allow the presence of a non-intervening observer
- Willingness to allow collection of minimal, approved visit-level variables
- Adult patients able to provide written informed consent
- Minor patients (under 18 years of age) with parent or legally authorized representative permission
- Assent obtained from minors as follows:
Show all 14Show fewer
- Verbal assent for minors aged 7-12 years
- Written assent for minors aged 13-17 years
- No formal assent required for children under 7 years of age (developmentally appropriate explanation provided when feasible)
- Ability of patient or legally authorized representative to understand and communicate in English
- Exclusion Criteria for Primary Subjects (endodontics residents) :
- Not engaged in clinical endodontic care during the study window
- Known dermatologic, cardiovascular, neurologic, or other medical conditions that could interfere with safe or accurate heart rate monitoring
- Unwilling or unable to provide informed consent or comply with study procedures
Who cannot join
- Decline consent, permission, or assent
- Withdraw participation at any time
- Prisoners or individuals under custodial supervision
- Pregnant patients
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
- This study will enroll approximately 12 endodontists (primary subjects) and approximately 120 patients (secondary subjects) undergoing routine endodontic treatment (primary root canal treatment or retreatment), resulting in approximately 120 observed treatment sessions. Patients will be treated as part of standard clinical care and will not receive any experimental intervention.
- Participating endodontists will wear an Apple Watch to continuously monitor heart rate (HR) during routine endodontic procedures. The Apple Watch contains built-in physiological sensors that automatically record heart rate. HR data are stored locally in the Apple Health app on a study-designated iPhone assigned for research use and handled solely by the Principal Investigator (PI). No real-time data transmission or cloud-based sharing occurs during data recording. At designated intervals, the PI will use the Apple Health app's built-in "Export Health Data" function, which generates a ZIP file containing an export.xml file with sensor-recorded data. The ZIP file will be uploaded directly from the study iPhone to a secure, university-approved UI Box Health Data Folder designated for the study. No research-specific Apple ID, cloud account, or third-party data-sharing platform will be used.
- A trained, non-intervening observer will record start and stop timepoints of predefined endodontic treatment stages to align HR signals with procedural phases. These stages include patient presentation, examination, informed consent, local anesthesia administration, rubber dam placement, access cavity preparation, root canal instrumentation, obturation, and final radiographic assessment. The observer will document only minimal, non-identifiable procedural variables necessary for analysis, including treatment type (primary root canal treatment or retreatment), treatment difficulty level (based on the AAE Endodontic Case Difficulty Assessment), and patient age category. No patient identifiers or protected health information (PHI) will be recorded.
- Each participating endodontist will complete the Perceived Stress Questionnaire (PSQ) two times in total at baseline and at the conclusion of study participation to assess perceived stress levels and evaluate associations between baseline stress and physiological stress responses during treatment. The PSQ requires approximately 5 minutes to complete. Endodontists will not complete questionnaires for individual patient encounters. HR data and permitted procedural variables will be coded, securely stored in the UI Box Health Data Folder, and analyzed to assess HR variation across endodontic treatment stages and treatment difficulty levels. No additional patient identifiers or PHI will be collected beyond what is specified above.
- Conditions
- Occupational 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 |
|---|---|---|
| Patients need Root canal treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in heart rate (HR) of endodontists measured across predefined stages of endodontic treatment.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Aug 2027 (estimated)
- Primary completion15 May 2028 (estimated)
- Study completion15 Jun 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
- 12 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
- NCT07498348
- Sponsor's protocol ID
- STUDY2026-0077
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 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 Evaluation of Endodontics Occupational Stress
- ClinicalTrials.gov ID
- NCT07498348
- Acronym / sponsor ID
- STUDY2026-0077
- Conditions
- Occupational Stress
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 1 Aug 2027 (estimated)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 Jun 2029 (estimated)
- First posted
- 27 Mar 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 approximately 12 endodontists (primary subjects) and approximately 120 patients (secondary subjects) undergoing routine endodontic treatment (primary root canal treatment or retreatment), resulting in approximately 120 observed treatment sessions. Patients will be treated as part of standard clinical care and will not receive any experimental intervention.
- Participating endodontists will wear an Apple Watch to continuously monitor heart rate (HR) during routine endodontic procedures. The Apple Watch contains built-in physiological sensors that automatically record heart rate. HR data are stored locally in the Apple Health app on a study-designated iPhone assigned for research use and handled solely by the Principal Investigator (PI). No real-time data transmission or cloud-based sharing occurs during data recording. At designated intervals, the PI will use the Apple Health app's built-in "Export Health Data" function, which generates a ZIP file containing an export.xml file with sensor-recorded data. The ZIP file will be uploaded directly from the study iPhone to a secure, university-approved UI Box Health Data Folder designated for the study. No research-specific Apple ID, cloud account, or third-party data-sharing platform will be used.
- A trained, non-intervening observer will record start and stop timepoints of predefined endodontic treatment stages to align HR signals with procedural phases. These stages include patient presentation, examination, informed consent, local anesthesia administration, rubber dam placement, access cavity preparation, root canal instrumentation, obturation, and final radiographic assessment. The observer will document only minimal, non-identifiable procedural variables necessary for analysis, including treatment type (primary root canal treatment or retreatment), treatment difficulty level (based on the AAE Endodontic Case Difficulty Assessment), and patient age category. No patient identifiers or protected health information (PHI) will be recorded.
- Each participating endodontist will complete the Perceived Stress Questionnaire (PSQ) two times in total at baseline and at the conclusion of study participation to assess perceived stress levels and evaluate associations between baseline stress and physiological stress responses during treatment. The PSQ requires approximately 5 minutes to complete. Endodontists will not complete questionnaires for individual patient encounters. HR data and permitted procedural variables will be coded, securely stored in the UI Box Health Data Folder, and analyzed to assess HR variation across endodontic treatment stages and treatment difficulty levels. 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
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients need Root canal treatment | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of approximately 132 subjects will be enrolled in this study, consisting of approximately 12 endodontics (primary subjects) and approximately 120 patients (secondary subjects). Each participating endodontics will be observed during approximately 10 endodontic treatment sessions, resulting in an estimated total of 120 clinical sessions for data collection. Each patient will participate in one clinical encounter only, while resident participation will continue throughout the data collection period.
Key inclusion criteria (14 listed)
- Scheduled to receive standard endodontic care with a participating endodontics resident during the study period
- Willingness to allow the presence of a non-intervening observer
- Willingness to allow collection of minimal, approved visit-level variables
- Adult patients able to provide written informed consent
- Minor patients (under 18 years of age) with parent or legally authorized representative permission
Key exclusion criteria (4 listed)
- Decline consent, permission, or assent
- Withdraw participation at any time
- Prisoners or individuals under custodial supervision
- Pregnant patients
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
The change in heart rate (HR) of endodontists measured across predefined stages of endodontic treatment.
Time frame: Periprocedural
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 14 inclusion and 4 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?
The change in heart rate (HR) of endodontists measured across predefined stages of endodontic treatment. (time frame: Periprocedural). 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.