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

Pediatric Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884780
• Other study ID #: 09 01-020E
• Status: Completed
• Phase: N/A
• First received: April 20, 2009
• Last updated: July 30, 2013
• Start date: April 2009
• Est. completion date: July 2009

Study information

• Verified date: July 2013
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pediatric Pain

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish initial acceptability and feasibility of an electronic tool for pain assessment.		One-time standard of care visit.	No