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

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Cincinnati VA Medical Center
ClinicalTrials.gov Identifier:
NCT00208052
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 1

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

No publications provided

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

ClinicalTrials.gov processed this record on October 23, 2014