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RECRUITING
NCT06164028

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

Sponsor: Duke University

View on ClinicalTrials.gov

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

OTHER

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