Assessing caregiver and clinician evaluations of acute pain in young children
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.
This study is trying to see how well caregivers and doctors can describe pain in young children to help create better ways to measure pain in future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06164028 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the clarity and validity of caregiver-reported and clinician-reported assessments of acute pain in infants and young children aged 0 to less than 2 years. It involves conducting 60-minute cognitive interviews via phone or Zoom with caregivers of children experiencing acute pain and clinicians who treat these patients. The goal is to develop reliable clinical outcome assessments that can be used in future clinical trials for pain therapeutics specifically designed for this age group. The study focuses on understanding the experiences of both caregivers and clinicians to improve pain assessment tools.
Who should consider this trial
Good fit: Ideal candidates include caregivers of children aged 0 to less than 2 years who have experienced acute pain recently, as well as clinicians who treat pediatric patients in this age group.
Not a fit: Patients who do not have acute pain or are outside the specified age range will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of acute pain in infants and young children, improving their treatment outcomes.
How similar studies have performed: While the approach of assessing pain in young children is challenging, similar qualitative studies have shown promise in developing effective outcome measures in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Durham, North Carolina
- Duke Clinical Research Institute — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Kanecia Zimmerman, MD, MPH — Duke University
- Study coordinator: Sophie Wang, MBBS, MHS
- Email: sophie.wang@duke.edu
- Phone: 919-668-5971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.