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OpenTrials
Completed

NCT Number: NCT00884780

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

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.

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Key information

Conditions

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To establish initial acceptability and feasibility of an electronic tool for pain assessment.

    Time frame: One-time standard of care visit.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 21, 2009
Registry last updated
Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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