Development of a Questionnaire to Measure Hypervigilance for Visceral Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01166802
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : July 21, 2010
Takeda Pharmaceuticals North America, Inc.
Information provided by:
University of North Carolina, Chapel Hill

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.

Condition or disease
Irritable Bowel Syndrome

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
Actual Enrollment : 157 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Questionnaire to Measure Hypervigilance for Visceral Pain
Study Start Date : February 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01166802

United States, North Carolina
UNC Center for Clinical and Translational Research
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Takeda Pharmaceuticals North America, Inc.
Principal Investigator: William E Whitehead, PhD University of North Carolina, Chapel Hill

Responsible Party: William E Whitehead, PhD/Professor of Medicine, University of North Carolina, Chapel Hill Identifier: NCT01166802     History of Changes
Other Study ID Numbers: 07-005L
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: July 21, 2010
Last Verified: July 2010

Keywords provided by University of North Carolina, Chapel Hill:
questionnaire development
pain sensitivity

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Visceral Pain
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nociceptive Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms