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NCT00208052 Clinical Trial

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

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00208052
Other study ID # 02-11-1-1EE
Secondary ID
Status Completed
Phase Phase 1
First received September 13, 2005
Last updated September 13, 2005
Start date January 2004
Est. completion date July 2005

Study information
Verified date September 2005
Source Cincinnati VA Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
United States VA Medical Center Cincinnati Ohio

Sponsors (2)
Lead Sponsor Collaborator
VA Office of Research and Development PriCara, Unit of Ortho-McNeil, Inc.

Country where clinical trial is conducted

United States, 

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