- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00884780
Development of a New Electronic Measure of Pediatric Pain: A Pilot Study
Study Overview
Status
Conditions
Detailed Description
Approximately 1 in 4 children aged 5-18 report experiencing pain. As many as 2 in 3 of these children will develop a significant physical, emotional, social or academic impairment. Recent research has identified pediatric pain as an area where biological, psychological and social treatments can interact to provide substantial changes in pain symptoms. However, there is a lamentable dearth of empirical studies evaluating the efficacy of treatments for chronic pain in children. These findings necessitate more intensive efforts to improve methods on initial assessment and treatment, but an important first step is to improve the sensitivity of outcome evaluation.
Existing measures of pediatric pain have been concerned with symptom intensity and the general locus of pain. Children are traditionally asked to mark with a number or a color the region in which they experience pain. This is helpful for understanding generality that a large area such as the head, joints, or stomach hurts. However, it does not allow the child the option to specify a narrow area of discomfort within a broader region (e.g., upper right quadrant of the stomach). Consequently, current pain instruments may lead to an inaccurate or imprecise understanding of a child's pain, which can adversely impact clinical care of the quality of clinical trials.
The current study will compare a widely used paper-based "pain mapping" tool to a new electronic tool designed by study investigators to capture the same information as the paper measure, while adding more precision regarding pain regions and greater range in terms of pain intensity. We expect that children's responses on these two measures (pencil/paper and electronic) will be generally similar, but we expect that the electronic measure will map more closely onto the Attending Physician's notes regarding discrete pain location, intensity, and/or diagnosis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Missouri
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Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Presentation to either APC Clinic or IPM Clinic.
- Child participant is 8-17 years of age.
Exclusion Criteria:
- Child/parent not English speaking.
- Child unable to see computer screen or interact with the keyboard or mouse.
- Parent/child unable or unwilling to provide permission/assent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Pediatric Pain
Children between the ages of 8 and 17 experiencing pain.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To establish initial acceptability and feasibility of an electronic tool for pain assessment.
Time Frame: One-time standard of care visit.
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One-time standard of care visit.
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Collaborators and Investigators
Investigators
- Study Chair: Craig A Friesen, M.D., Children's Mercy Hospital - Gastroenterology:Abdominal Pain Team
- Study Chair: Mark Connelly, PhD, The Children's Mercy Hospital: Integrative Pain Medicine Clinic
- Study Chair: Joy Weydert, M.D, The Children's Mercy Hospital: Integrative Pain Management Clinic
- Study Chair: Christopher C Cushing, PhD, Children's Mercy Hospital Kansas City
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 09 01-020E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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