Development of a Questionnaire to Measure Hypervigilance for Visceral Pain

Irritable Bowel Syndrome Clinical Trial

Official title:

Development of a Questionnaire to Measure Hypervigilance for Visceral Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166802
• Other study ID #: 07-005L
• Status: Completed
• Phase: N/A
• First received: July 19, 2010
• Last updated: July 19, 2010
• Start date: February 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unites States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Visceral Pain

Locations

Country	Name	City	State
United States	UNC Center for Clinical and Translational Research	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States,