Pain MeasurementNCT04392180
COA-APTIC Caregiver Concept Elicitation Study
An observational study of Pain Measurement, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Measurement
- What is being tested?
- Qualitative Interview
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2021to 26 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be caregivers of children 0 to <3 years old who have experienced acute pain. Eligible caregivers will be identified by Pediatric Trials Network sites across the United States. Eligible participants will be identified through recruitment for a pre-existing Pediatric Trials Network study called Pharmacokinetics and Safety of Anesthetics and Analgesics in Children and Adolescents.
Who may be able to join
- Cares for a child who is both:
- Between 0 and <3 years of age
- Experiencing or has experienced acute pain in one of the following categories:
- Malignant or non-malignant visceral or hematologic disease
- Surgery (or other procedure)
- Trauma or injury
Show all 10Show fewer
- Congenital conditions
- Is over the age of 18 years old.
- Can speak and understand English.
- Is capable of and willing to provide informed consent for interview participation and to collect medical data from the child's medical record.
Who cannot join
- Lack of access to a telephone or computer for interview
- Has a child with acute pain that is extremely premature (less than 32 weeks gestation at the time of enrollment) and no other eligible child.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COA-APTIC Caregiver Concept Elicitation Study: A Qualitative Concept Elicitation Study to Identify Important Aspects of Pain Assessment, Treatment, and Response to Treatment in Children Who Are 0 to <3 Years of Age
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.
Read the detailed description
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.
- Conditions
- Pain Measurement
- Being tested
- Qualitative Interview
- Keywords
- acute pain, pediatrics
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative InterviewOther
There is no intervention as part of this study. Caregivers will participate in a qualitative interview over the phone or by video.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Caregivers who care for a child that is both under 3 years of age and has experienced acute pain.
This cohort will participate in a qualitative interview about pain assessment, treatment, and response to treatment in their child. Receives: Other: Qualitative Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start23 Jun 2021
- Primary completion26 Apr 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain MeasurementStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Bryce Reeve, PhD, Principal investigator, Duke UniversityKanecia Zimmerman, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392180
- Sponsor's protocol ID
- Pro00105117
- Status last verified
- Aug 2021
- First submitted
- 14 May 2020
- Last updated
- 9 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside of the study team.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COA-APTIC Caregiver Concept Elicitation Study: A Qualitative Concept Elicitation Study to Identify Important Aspects of Pain Assessment, Treatment, and Response to Treatment in Children Who Are 0 to <3 Years of Age
- ClinicalTrials.gov ID
- NCT04392180
- Acronym / sponsor ID
- Pro00105117
- Conditions
- Pain Measurement
- Keywords
- acute pain, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Other: Qualitative InterviewCaregivers who care for a child that is both under 3 years of age and has experienced acute pain. This cohort will participate in a qualitative interview about pain assessment, treatment, and response to treatment in their child. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be caregivers of children 0 to <3 years old who have experienced acute pain. Eligible caregivers will be identified by Pediatric Trials Network sites across the United States. Eligible participants will be identified through recruitment for a pre-existing Pediatric Trials Network study called Pharmacokinetics and Safety of Anesthetics and Analgesics in Children and Adolescents.
Key inclusion criteria (10 listed)
- Cares for a child who is both:
- Is over the age of 18 years old.
- Can speak and understand English.
- Is capable of and willing to provide informed consent for interview participation and to collect medical data from the child's medical record.
Key exclusion criteria (2 listed)
- Lack of access to a telephone or computer for interview
- Has a child with acute pain that is extremely premature (less than 32 weeks gestation at the time of enrollment) and no other eligible child.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative InterviewThere is no intervention as part of this study. Caregivers will participate in a qualitative interview over the phone or by video. | Other | Caregivers |
Primary outcome
Caregiver perspective on how to identify or recognize pain in children 0 to <3 years old.
Time frame: 1 hour
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.
Caregiver perspective on how and when to intervene for acute pain in children 0 to <3 years old.
Time frame: 1 hour
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.
Caregiver perspective on how to evaluate response to treatment for acute pain in children 0 to <3 years old.
Time frame: 1 hour
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.
Caregiver perspective on important side effects of acute pain therapeutics in children 0 to <3 years old.
Time frame: 1 hour
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside of the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryce Reeve, PhD principal investigator
Duke University
Kanecia Zimmerman, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Measurement, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver perspective on how to identify or recognize pain in children 0 to <3 years old. (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.