Clinical Research Directory
Browse clinical research sites, groups, and studies.
COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
Sponsor: Duke University
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).
Official title: A Qualitative Cognitive Interview Study to Evaluate Comprehensibility and Content Validity of a Caregiver Observer-reported Assessment and a Clinician-reported Assessment of Acute Pain in Infants and Young Children Who Are 0 to <2 Years of Age.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2023-08-15
Completion Date
2026-08-31
Last Updated
2025-09-09
Healthy Volunteers
Yes
Conditions
Interventions
cognitive interview
Participants will take part in a semi-structured qualitative interview (\~1 hour).
Locations (1)
Duke Clinical Research Institute
Durham, North Carolina, United States