Irritable Bowel SyndromeNCT01166802
Development of a Questionnaire to Measure Hypervigilance for Visceral Pain
An observational study of Irritable Bowel Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- clinical diagnosis of IBS
- meets Rome III criteria for IBS
- women or men aged 18 or older
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center for Clinical and Translational Research
Chapel Hill, North Carolina, 27599
About this study
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- questionnaire development, hypervigilance, pain sensitivity
- Medical subject headings
- Irritable Bowel Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startFeb 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Investigators
- William E Whitehead, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166802
- Sponsor's protocol ID
- 07-005L
- Status last verified
- Jul 2010
- First submitted
- 19 Jul 2010
- Last updated
- 21 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Questionnaire to Measure Hypervigilance for Visceral Pain
- ClinicalTrials.gov ID
- NCT01166802
- Acronym / sponsor ID
- 07-005L
- Conditions
- Irritable Bowel Syndrome
- Keywords
- questionnaire development, hypervigilance, pain sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Feb 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- clinical diagnosis of IBS
- meets Rome III criteria for IBS
- women or men aged 18 or older
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William E Whitehead, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2010.