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| Sponsor: | University of North Carolina, Chapel Hill |
|---|---|
| Collaborator: |
Takeda Pharmaceuticals North America, Inc. |
| Information provided by: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01166802 |
Purpose
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.
| Condition |
|---|
|
Irritable Bowel Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Development of a Questionnaire to Measure Hypervigilance for Visceral Pain |
| Enrollment: | 157 |
| Study Start Date: | February 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| UNC Center for Clinical and Translational Research | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | William E Whitehead, PhD | University of North Carolina, Chapel Hill |
More Information
| Responsible Party: | William E Whitehead, PhD/Professor of Medicine, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01166802 History of Changes |
| Other Study ID Numbers: | 07-005L |
| Study First Received: | July 19, 2010 |
| Last Updated: | July 19, 2010 |
| Health Authority: | Unites States: Institutional Review Board |
|
questionnaire development hypervigilance pain sensitivity |
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |