An observational study in Irritable Bowel Syndrome, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-21.
Sponsored by University of North Carolina, Chapel Hill · Observational
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 157 is close to the median of 150 across 178 observational studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill