- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01166802
Development of a Questionnaire to Measure Hypervigilance for Visceral Pain
July 19, 2010 updated by: University of North Carolina, Chapel Hill
The aim of this study is to develop and validate a questionnaire (non-invasive technique) to identify patients who are hypervigilant for noxious visceral sensations and who show a lower threshold to report pain.
This questionnaire would be useful in studies investigating the role of visceral pain hypervigilance and pain sensitivity in the comorbidity of IBS with other somatic disorders.
Study Overview
Status
Completed
Conditions
Detailed Description
Methods: There are two phases to the project: (1) Development of the pool of items (questions), and (2) validating individual items based on their correlation with an objective gold standard - the response criterion statistic, B, calculated from a barostat test of pain sensitivity.
We will perform barostat tests of pain thresholds and other measures of pain sensitivity that are based on sensory decision theory analysis in a relatively large group of 84 IBS patients.
Sensory decision theory divides pain perception into two components: a perceptual sensitivity index (P(A)) and a response criterion (B).
The response criterion is sensitive to cognitive and psychological influences on pain perception.
We will use this index (B) as the gold standard against which to select items for a scale to measure hypervigilance for visceral pain.
The process will involve (a) pooling items from existing questionnaires that seem related to the concept, (b) obtaining additional questions from consultants who are experts in visceral perception and psychometric test development, (c) identifying the items that show the strongest correlations with the response criterion, (d using principal components analysis to reduce the items to the smallest number of non-redundant items that predict the response criterion and treating this as a provisional questionnaire of hypervigilance, and (e calculating psychometric characteristics of this questionnaire.
Study Type
Observational
Enrollment (Actual)
157
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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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Center for Clinical and Translational Research
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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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects diagnosed with irritable bowel syndrome, age 18 or older, of any race or gender, will be enrolled.
These subjects will be recruited from the Functional GI & Motility Disorder's Registry of Research Participants.
Description
Inclusion Criteria:
- clinical diagnosis of IBS
- meets Rome III criteria for IBS
- women or men aged 18 or older
Exclusion Criteria:
- use of IBS-specific compounds, opiates, anticholinergics, or any drug likely to cause constipation as a side-effect
- use of analgesics for 48 hours prior to the study
- hypothyroid
- history of bowel resection except appendectomy or cholecystectomy
- psychotic disorder, major depression, substance abuse (other than tobacco)or other psychiatric condition likely to interfere with the conduct of the study
- renal disease
- patients with inflammatory or ischemic disease of the rectum
- known to be unreliable.
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
February 1, 2008
Primary Completion (ACTUAL)
June 1, 2010
Study Completion (ACTUAL)
June 1, 2010
Study Registration Dates
First Submitted
July 19, 2010
First Submitted That Met QC Criteria
July 19, 2010
First Posted (ESTIMATE)
July 21, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
July 21, 2010
Last Update Submitted That Met QC Criteria
July 19, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-005L
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.
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