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

NCT ID: NCT00884780

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Pediatric Pain

Keywords

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Electronic Diary Body Map Electronic Measure of Pediatric Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric Pain

Children between the ages of 8 and 17 experiencing pain.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Verrill Schurman

Co-Director Abdominal Pain Team

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Craig A Friesen, M.D.

Role: STUDY_CHAIR

Children's Mercy Hospital - Gastroenterology:Abdominal Pain Team

Mark Connelly, PhD

Role: STUDY_CHAIR

The Children's Mercy Hospital: Integrative Pain Medicine Clinic

Joy Weydert, M.D

Role: STUDY_CHAIR

The Children's Mercy Hospital: Integrative Pain Management Clinic

Jennifer V Schurman, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Christopher C Cushing, PhD

Role: STUDY_CHAIR

Children's Mercy Hospital Kansas City

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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09 01-020E

Identifier Type: -

Identifier Source: org_study_id