Clinical Trials Directory

Trials / Completed

CompletedNCT00884780

Development of a New Electronic Measure of Pediatric Pain: A Pilot Study

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Children's Mercy Hospital Kansas City · Academic / Other
Sex
All
Age
8 Years – 17 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to test the accuracy of a computer-based program to self-report the location and intensity of a child's pain in comparison to a traditional self-report paper and pencil measure and physician physical exam. Using a computer to assess pediatric pain may offer many advantages and improvements in how pediatric pain is diagnosed and treated.

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.

Conditions

Timeline

Start date
2009-04-01
Primary completion
2009-06-01
Completion
2009-07-01
First posted
2009-04-21
Last updated
2013-07-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00884780. Inclusion in this directory is not an endorsement.