Recruiting

Clinical Outcome Assessments

Sponsor:

Duke University

Code:

NCT06164028

Conditions

Acute Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

cognitive interview

Study Details

Brief summary:

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).

Conditions

Acute Pain

Study ID

NCT06164028

Start date

Aug 15, 2023

Status verified date

Sep, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Caregiver

Participants will take part in a semi-structured qualitative interview (\~1 hour).

The first set of questions will provide an opportunity for the caregiver to describe the type of conditions or injuries their child has experienced and how their child reacted to the potentially painful experiences.

Subsequently, the cognitive interview scripts will be structured to evaluate different components of the questionnaire (ObsRO measure), including the instructions, the question stems, the response options, and other key aspects of the COA.Once the participant has completed the questionnaire, the interviewer will probe on additional issues related to informing the assessment of content validity.

Clinician

Participants will take part in a semi-structured qualitative interview (\~1 hour).

The first set of questions will provide an opportunity for the clinicians to describe observable indicators that a young child is in pain.

4 YouTube video links based on age groups (birth to 1 month,1 month to 6 months, 6 months to 12 months, and12 months to 24 months), will be reviewed by participants. Clinicians will be asked to rate the child's pain using the ClinRO measures while being probed for question content and understanding.

Subsequently, the cognitive interview scripts will be structured to evaluate different components of the ClinRO measures, including the instructions, the question stems, the response options, and other key aspects of the COA. Once the participant has completed the questionnaire, the interviewer will probe on additional issues related to informing the assessment of content validity.

Interventions

cognitive interview

Participants will take part in a semi-structured qualitative interview (\~1 hour).

Primary outcome measure

  • Number of participants who understand features of the clinical outcome assessments [ Time Frame: Approximately 1 hour ]
  • Number of participants who find the indicators included in the clinical outcome assessments complete and relevant [ Time Frame: Approximately 1 hour ]

Central Contacts and Locations

Central contacts

Sophie Wang, MBBS, MHS

919-668-5971sophie.wang@duke.edu

Locations

Duke Clinical Research Institute

Recruiting

Durham, North Carolina, United States, 27701

Contacts

Sophie Wang, MBBS, MHS

919-668-5971sophie.wang@duke.edu

More Information

Sponsor

Duke University

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-09-09.