NCT00619125

Proposal Evaluating Time-specific Relationships Between Variables of Pain, Stress, and Bloating in IBS Diarrhea and Constipation Symptoms Using a Palm Pilot

A Proposal to Evaluate Time-specific Relationships Between Variables of Pain, Stress, and Bloating in the Onset of IBS Diarrhea and Constipation Symptoms Using Ecological Momentary Assessment (EMA)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 85 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Purpose: The associations between pain, stress, bloating, and their short interval temporal relationships to defecation in IBS D, C \& M are of great interest to the field of functional GI disorders, but have not been adequately studied. Broad recall based assessments (i.e.,over past week or month) of pain and bloating have been key features of the diagnosis of IBS, however such long term retrospective recall of symptom experience has been shown to be unreliable and influenced by outside factors (heuristics, recall bias, etc.). Short interval assessment may provide a more accurate picture of patient symptom experience Participants: Patients with IBS in general and IBS subtypes (IBS-C, D, M) Procedures (methods): Study participants could be asked to record data at randomly assigned points throughout the day, as well as during the course of a diarrheal or constipated stool (i.e., prior to and right after a bowel movement).

Conditions

• IBS, Diarrhea Predominant
• IBS, Constipation Predominant
• IBS, Mixed Symptoms

Interventions

Type	Name	Description
OTHER	palm pilot recording responses to questionnaires	Short interval assessment (provided by data from palm pilot) may provide a more accurate picture of patient symptom experience.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2008-02-20
• Last updated: 2017-06-20