This is a concept elicitation study to identify important aspects of pain assessment, treatment, and response to treatment in children under than 3 years of age from a caregiver's perspective.
The purpose of this study is to identify important endpoints and outcomes for use in pediatric trials for acute pain therapeutics in infants and young children from a caregiver's perception. Study team members will conduct phone-based qualitative interviews, using a semi-structured interview guide, with 42 primary caregivers of pediatric patients under 3 years of age who are experiencing or have experienced acute pain. Once participants give verbal consent, they will fill out a demographics form. Interviews will last about one hour and will address the participant's experience recognizing and managing their child's acute pain. The investigators will use these concept elicitation interviews to identify important aspects of acute pain assessment, treatment, and response to treatment in children who are under 3 years old. Interviews will be audio recorded and transcribed with participant permission. Transcripts or interviewer notes will be reviewed by two analysts and will be double coded until inter-rater reliability is reached by agreement of at least 80%. The study team will conduct a thematic analysis of the coded transcripts. This is a minimal risk study. All information will be kept confidential and information will be stored on a secure network which is only accessible to the study team.
Study Type
OBSERVATIONAL
Enrollment
44
There is no intervention as part of this study. Caregivers will participate in a qualitative interview over the phone or by video.
Duke University
Durham, North Carolina, United States
Caregiver perspective on how to identify or recognize pain in children 0 to <3 years old.
A 1-hour qualitative interview will be conducted and transcript or interviewer notes will be coded to assess how caregivers identify and recognize acute pain in infants and young children.
Time frame: 1 hour
Caregiver perspective on how and when to intervene for acute pain in children 0 to <3 years old.
A 1-hour qualitative interview will be conducted and transcript or interviewer notes will be coded to assess caregiver's perspective on how and when to treat acute pain in infants and young children.
Time frame: 1 hour
Caregiver perspective on how to evaluate response to treatment for acute pain in children 0 to <3 years old.
A 1-hour qualitative interview will be conducted and transcript or interviewer notes will be coded to assess how caregivers evaluate response to treatment for acute pain in infants and young children.
Time frame: 1 hour
Caregiver perspective on important side effects of acute pain therapeutics in children 0 to <3 years old.
A 1-hour qualitative interview will be conducted and transcript or interviewer notes will be coded to assess caregiver's perspective on important side effects of acute pain in infants and young children.
Time frame: 1 hour
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