NCT07356141尚未招募不适用
Apple Watch Assessment of Dental Stress in Special Needs Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Heart rate changes in dental students during dental procedures
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
patient with special needs
Patients with capability
结局指标
主要结局
Heart rate changes in dental students during dental procedures
时间窗: During each dental treatment session per session
次要结局
未报告次要终点
研究者
Shlomo Elbahary
Clinical Associate Professor
University of Illinois at Chicago
研究点 (1)
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