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

NCT ID: NCT00208052

Last Updated: 2005-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PriCara, Unit of Ortho-McNeil, Inc.

INDUSTRY

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role lead

Principal Investigators

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Veronica B Steffen, MSN,RN

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center

Amy Pettigrew, PHD,RN

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati, College of Nursing and Health

Locations

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VA Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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02-11-1-1EE

Identifier Type: -

Identifier Source: org_study_id