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

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Completed
CT.gov ID
NCT00884780
Collaborator
(none)
20
1
3
6.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development of a New Electronic Measure of Pediatric Pain: A Pilot Study
    Study Start Date :
    Apr 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2009
    Actual Study Completion Date :
    Jul 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    Pediatric Pain

    Children between the ages of 8 and 17 experiencing pain.

    Outcome Measures

    Primary Outcome Measures

    1. To establish initial acceptability and feasibility of an electronic tool for pain assessment. [One-time standard of care visit.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Mercy Hospital Kansas City Missouri United States 64108

    Sponsors and Collaborators

    • Children's Mercy Hospital Kansas City

    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
    • Principal Investigator: Jennifer V Schurman, PhD, Children's Mercy Hospital Kansas City
    • Study Chair: Christopher C Cushing, PhD, Children's Mercy Hospital Kansas City

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jennifer Verrill Schurman, Co-Director Abdominal Pain Team, Children's Mercy Hospital Kansas City
    ClinicalTrials.gov Identifier:
    NCT00884780
    Other Study ID Numbers:
    • 09 01-020E
    First Posted:
    Apr 21, 2009
    Last Update Posted:
    Jul 31, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Jennifer Verrill Schurman, Co-Director Abdominal Pain Team, Children's Mercy Hospital Kansas City

    Study Results

    No Results Posted as of Jul 31, 2013