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Understanding Pain in Infants and Young Children

This study, called COA-APTIC, is looking at how caregivers and doctors assess acute pain (sudden, short-term pain) in infants and young children aged 0 to less than 2 years old. It's an observational study, meaning participants will share their experiences and opinions rather than receiving a new treatment. The goal is to make sure that the tools used to measure pain in these young children are clear, complete, and relevant for future clinical trials. You could join if you are a caregiver for a child in this age range who has recently experienced acute pain due to conditions like surgery, injury, or certain illnesses, and you can speak English. The study aims to enroll 60 participants. We don't know the current recruitment status.

Study design
This is an observational study involving 60 participants. It uses qualitative interviews to understand how people assess pain.
What's involved
You would take part in one semi-structured interview lasting about one hour, conducted by phone or Zoom.
Compensation
Not stated in the trial record.
Follow-up
The primary goals are measured at approximately 1 hour, which is the duration of the interview.

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NCT06164028

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

Recruiting
Not specifiedAges 18+Observational
Duke University
~60 participants
Updated 2025-09-09 on ClinicalTrials.gov
What's tested:cognitive interview

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who understand features of the clinical outcome assessments
Measured over Approximately 1 hour
+1 more outcome measured

Conditions

Acute Pain

Explore related trials

Acute Pain

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Kanecia Zimmerman, MD, MPH · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Sophie Wang, MBBS, MHS
[email protected]
919-668-5971
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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.

What this trial measures

  • Number of participants who understand features of the clinical outcome assessmentsApproximately 1 hour

    Understanding (or clarity) of all features of the clinical outcome assessments (ObsRO measure or ClinRO measures) including, but not limited to, its instructions, questions, and response options.

  • Number of participants who find the indicators included in the clinical outcome assessments complete and relevantApproximately 1 hour

    Completeness and relevance of indicators included in the clinical outcome assessments (ObsRO measure or ClinRO measures) for capturing observable behaviors in young children when she/he is reacting to painful experiences.