NCT00884780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

2 months

First QC Date

April 20, 2009

Last Update Submit

July 30, 2013

Conditions

Pediatric Pain

Keywords

Electronic DiaryBody MapElectronic Measure of Pediatric Pain

Outcome Measures

Primary Outcomes (1)

  • To establish initial acceptability and feasibility of an electronic tool for pain assessment.

    One-time standard of care visit.

Study Arms (1)

Pediatric Pain

Children between the ages of 8 and 17 experiencing pain.

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • Presentation to either APC Clinic or IPM Clinic.
  • Child participant is 8-17 years of age.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Study Officials

  • 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

    STUDY CHAIR

  • Jennifer V Schurman, PhD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

  • Christopher C Cushing, PhD

    Children's Mercy Hospital Kansas City

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director Abdominal Pain Team

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 21, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations

US(1)