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

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ClinicalTrials.gov Identifier: NCT00208052
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Cincinnati VA Medical Center

Brief Summary:
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 or disease Phase
Pain Phase 1

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.

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : January 2004
Estimated Study Completion Date : July 2005

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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

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): 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

ClinicalTrials.gov Identifier: NCT00208052     History of Changes
Other Study ID Numbers: 02-11-1-1EE
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: September 2005