Development of a Questionnaire to Measure Hypervigilance for Visceral Pain

NCT01166802 | Completed

• 1 other identifier: 07-005L
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

questionnaire development; hypervigilance; pain sensitivity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• clinical diagnosis of IBS
• meets Rome III criteria for IBS
• women or men aged 18 or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

UNC Center for Clinical and Translational Research

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• William E Whitehead, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: February 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 21, 2010

Record last verified: 2010-07

Locations

US (1)