NCT06164028 COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
| NCT ID | NCT06164028 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Acute Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-08-15 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2023-08-15 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluate the content validity and comprehensibility of a caregiver observer-reported outcome assessment and clinician-reported assessments for acute pain in children aged 0 to \<2 years. The primary objective of the Qualitative Protocol in the UH3 phase study is to establish or create reliable Clinical Outcome Assessments (COAs) and endpoints that can assess acute pain during clinical trials of pain therapeutics specifically designed for infants and young children (0 - \<2 years).
Eligibility Criteria
Inclusion Criteria: Caregivers * Cares for a child who is both: Between 0 and \<2 years of age and experiencing or has experienced acute pain in the past four weeks in one of the following categories: Malignant or non-malignant visceral or hematologic disease; Surgery (or other procedure); Trauma or injury ; Congenital conditions * Is over the age of 18 years * Can speak and understand English or Spanish * Is capable of and willing to provide informed consent for interview participation and to collect data from the child's medical record. Clinicians * Practicing clinician in a clinical care environment * Treats or works with pediatric patients who are between 0 and \<2 years of age AND being treated for acute pain. * Cares for pediatric patients \>50% of their clinical time. * Holds one of the following titles/positions: physician, clinical pharmacist (Pharm D), nurse practitioner, physician's assistant, nurse (with a BSN/RN or higher) * Is over the age of 18 years * Can speak and understand English * Is capable of and willing to provide informed consent for interview participation. Exclusion Criteria: * Lack of access to a telephone or computer for interview * For caregivers, has a child with acute pain who is premature at less than 32 weeks corrected gestational age at the time of enrollment and no other eligible child.
Contact & Investigator
Kanecia Zimmerman, MD, MPH
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06164028 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06164028 currently recruiting?
Yes, NCT06164028 is actively recruiting participants. Contact the research team at sophie.wang@duke.edu for enrollment information.
Where is the NCT06164028 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06164028 clinical trial?
NCT06164028 is sponsored by Duke University. The principal investigator is Kanecia Zimmerman, MD, MPH at Duke University. The trial plans to enroll 60 participants.