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

Duke University · with Food and Drug Administration (FDA) · NCT06164028

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
60
US sites recruiting
1
Study start
August 15, 2023
Record last updated
September 9, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: cognitive interview

Conditions: Acute Pain

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Duke Clinical Research Institute

    Durham, NC 27701

    Site contact: Sophie Wang, MBBS, MHS · 919-668-5971 · sophie.wang@duke.edu

Study contacts (from the official record)

  • Sophie Wang, MBBS, MHS · 919-668-5971 · sophie.wang@duke.edu
All pain studies in North Carolina →
COA-APTIC Cognitive Interview Study of Caregiver and Clinician… (NCT06164028) | Bored Studies