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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jennifer Verrill Schurman, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00884780
First received: April 20, 2009
Last updated: July 30, 2013
Last verified: July 2013

April 20, 2009
July 30, 2013
April 2009
June 2009   (final data collection date for primary outcome measure)
To establish initial acceptability and feasibility of an electronic tool for pain assessment. [ Time Frame: One-time standard of care visit. ] [ Designated as safety issue: No ]
  • Electronic Body Map Questionnaire [ Time Frame: One-time SOC visit ] [ Designated as safety issue: No ]
  • Varni/Thompson Pediatric Pain Questionnaire [ Time Frame: One-time SOC visit ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00884780 on ClinicalTrials.gov Archive Site
Not Provided
  • Exit Interview to gather qualitative information regarding participant's perceptions of the different assessment instruments. [ Time Frame: One-time SOC visit ] [ Designated as safety issue: No ]
  • Attending Physician Form [ Time Frame: One-time SOC visit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Development of a New Electronic Measure of Pediatric Pain: A Pilot Study
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Presentation to either Abdominal Pain Clinic or Integrative Pain Management Clinic. A total of ten patients from each clinic, five (5) aged 8-12 and five (5) aged 13-17.

Pediatric Pain
Not Provided
Pediatric Pain
Children between the ages of 8 and 17 experiencing pain.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
8 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00884780
09 01-020E
No
Jennifer Verrill Schurman, Children's Mercy Hospital Kansas City
Children's Mercy Hospital Kansas City
Not Provided
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
Study Chair: Christopher C Cushing, PhD Children's Mercy Hospital
Children's Mercy Hospital Kansas City
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP