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Search / Trial NCT06164028

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

Launched by DUKE UNIVERSITY · Dec 1, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

The COA-APTIC Cognitive Interview Study is a clinical trial aimed at understanding how caregivers and clinicians assess acute pain in infants and young children, specifically those aged 0 to less than 2 years. The goal is to develop reliable methods to measure pain in these young patients, which is important for testing new pain treatments. The study is currently recruiting participants who can help researchers gather valuable information about how pain is experienced and reported in young children.

To be eligible, caregivers must be over 18 years old and care for a child in this age group who has had acute pain recently, such as from surgery, injury, or other medical conditions. Caregivers should be able to speak and understand either English or Spanish. Clinicians who treat young children with acute pain and spend most of their time working with pediatric patients can also participate if they meet certain qualifications. Participants can expect to share their experiences and insights through interviews, which will help improve pain assessments for young children in future medical treatments.

Gender

ALL

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 Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Kanecia Zimmerman, MD, MPH

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported