Clinical trial NCT00884780: Development of a New Electronic Measure of Pediatric Pain: A Pilot Study
Official title: Development of a New Electronic Measure of Pediatric Pain: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Pain
Keywords: Electronic Diary
Body Map
Electronic Measure of Pediatric Pain
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2009-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To establish initial acceptability and feasibility of an electronic tool for pain assessment.
timeFrame: One-time standard of care visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital - Gastroenterology:Abdominal Pain Team
name: Craig A Friesen, M.D.
role: STUDY_CHAIR
affiliation: The Children's Mercy Hospital: Integrative Pain Medicine Clinic
name: Mark Connelly, PhD
role: STUDY_CHAIR
affiliation: The Children's Mercy Hospital: Integrative Pain Management Clinic
name: Joy Weydert, M.D
role: STUDY_CHAIR
affiliation: Children's Mercy Hospital Kansas City
name: Jennifer V Schurman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Mercy Hospital Kansas City
name: Christopher C Cushing, PhD
role: STUDY_CHAIR
References: