Study to Understand How Caregivers and Clinicians Assess Acute Pain in Infants and Young Children Under 2 Years Old Using New Pain Evaluation Tools

What this Trial Is About

Researchers are evaluating the clarity and content validity of caregiver and clinician assessments designed to measure acute pain in infants and young children aged from birth to under 2 years. The study focuses on developing reliable Clinical Outcome Assessments COAs and endpoints that can be used in clinical trials for pain treatments targeted at this young population. This qualitative phase is part of a broader effort to improve pain assessment tools specifically for infants and toddlers. Participants will engage in approximately 60-minute semi-structured cognitive interviews conducted by trained interviewers via phone or Zoom. Caregivers will describe their childs pain experiences and provide feedback on the observer-reported outcome ObsRO measures. Clinicians will review video examples of infants and young children in pain and provide ratings using clinician-reported outcome ClinRO measures, followed by detailed evaluations of the assessment tools components. This approach aims to improve both sets of assessments by probing their instructions, questions, and response options. During the study, caregivers and clinicians will share their perspectives through in-depth interviews, providing qualitative data to help refine the pain assessment tools. Researchers will analyze how well participants understand the assessments and whether the tools include all relevant pain indicators. The study involves minimal risk but includes measures to protect confidentiality. Participation includes consenting to interviews and, for caregivers, possibly sharing medical record information. The study is expected to continue until August 2026.

COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children