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

This study has been completed.

Sponsors and Collaborators:	Department of Veterans Affairs PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:	Cincinnati VA Medical Center
ClinicalTrials.gov Identifier:	NCT00208052

Purpose

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 I

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Prospective Study

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208052

Locations

United States, Ohio
VA Medical Center
Cincinnati, Ohio, United States, 45220

Sponsors and Collaborators

Department of Veterans Affairs

PriCara, Unit of Ortho-McNeil, Inc.

Investigators

Principal Investigator:	Veronica B Steffen, MSN,RN	Department of Veterans Affairs
Principal Investigator:	Amy Pettigrew, PHD,RN	University of Cincinnati, College of Nursing and Health

More Information

Study ID Numbers:	02-11-1-1EE
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00208052
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 16, 2009