- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00208052
Behavioral Indicators of Pain:Tool Development With Concurrent and Construct Validity
September 13, 2005 updated by: US Department of Veterans Affairs
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.
Study Overview
Status
Completed
Conditions
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
Enrollment
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45220
- VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Veronica B Steffen, MSN,RN, VA Medical Center
- Principal Investigator: Amy Pettigrew, PHD,RN, University of Cincinnati, College of Nursing and Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion
July 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
September 21, 2005
Last Update Submitted That Met QC Criteria
September 13, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Other Study ID Numbers
- 02-11-1-1EE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.