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

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ClinicalTrials.gov Identifier: NCT00884780
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):

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
Pediatric Pain

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 : April 2009
Primary Completion Date : June 2009
Study Completion Date : July 2009
Groups and Cohorts

Group/Cohort
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. [ Time Frame: One-time standard of care visit. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884780


Locations
United States, Missouri
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
Study Chair: Christopher C Cushing, PhD Children's Mercy Hospital
More Information

Responsible Party: Jennifer Verrill Schurman, Co-Director Abdominal Pain Team, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00884780     History of Changes
Other Study ID Numbers: 09 01-020E
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by Jennifer Verrill Schurman, Children's Mercy Hospital Kansas City:
Electronic Diary
Body Map
Electronic Measure of Pediatric Pain