COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
Recruiting now
Conditions studied: Acute Pain
In brief
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).
Key facts
- Study ID
- NCT06164028
- Run by
- Duke University
- People needed
- 60
- Starts
- 2023-08-15
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2025-09-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Duke Clinical Research Institute — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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