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

RecruitingObservational studyHealthy volunteers welcome

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.

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Full 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.

About the study

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).

What is being tested

Sponsor: Duke University · Participants: 60 · Started: Aug 15, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06164028

Locations in the U.S.

North CarolinaDuke Clinical Research Institute, Durham

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.