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Behavioral Indicators of Pain:Tool Development With Concurrent and Construct Validity

This study has been completed.
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Cincinnati VA Medical Center Identifier:
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
The purpose of the pilot study is to validate an assesment tool to be used in the assessment of pain in the verbal, congitively intact patient. The ultimate goal is to be able to validate this tool in the non-verbal/cognitively impaired patient.

Condition Phase
Pain Phase 1

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective

Further study details as provided by Cincinnati VA Medical Center:

Estimated Enrollment: 10
Study Start Date: January 2004
Estimated Study Completion Date: July 2005
Detailed Description:
Patinets will be observed for 2 six hour periods. Patients will be videotaped; every 10 minutes: EMG reading will be obtained; hourly - vital signs, pain score and saliva cortisol from "spit" will be obtained.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • In-patients with Pain diagnosis

Exclusion Criteria:

  • Unable to talk and or understand basic instructions
  • Under age 18 or over age 75
  • Receiving pain medications regularly
  Contacts and Locations
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Please refer to this study by its identifier: NCT00208052

United States, Ohio
VA Medical Center
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
VA Office of Research and Development
PriCara, Unit of Ortho-McNeil, Inc.
Principal Investigator: Veronica B Steffen, MSN,RN VA Office of Research and Development
Principal Investigator: Amy Pettigrew, PHD,RN University of Cincinnati, College of Nursing and Health
  More Information Identifier: NCT00208052     History of Changes
Other Study ID Numbers: 02-11-1-1EE
Study First Received: September 13, 2005
Last Updated: September 13, 2005 processed this record on August 22, 2017