Status:
RECRUITING
Outpatient VR (Virtual Reality)-Brain-gut Behavioral Therapies (BGBT) in Inflammatory Bowel Disease (IBD)
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
American Gastroenterological Association
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This research study is being done to learn if a virtual reality (VR)-directed BGBT program is feasible and acceptable for patients to enhance pain treatment for patients with IBD. The study hypothesi...
Eligibility Criteria
Inclusion
- Adult outpatients (18 years and older) that carry a diagnosis of IBD and confirmed in the electronic health record (EHR) as receiving IBD-targeted treatment
- IBD-targeted treatment include 5-aminosalicylates, thiopurines, biologics, or small molecules such as Janus kinase inhibitor (JAK) inhibitors or sphingosine-1-receptor modulators.
- Self-report abdominal pain with an average severity ≥ 2 on a 0-10 pain scale over the last 24 hours,
- Participants are willing and able to pick-up and drop-off VR equipment at University of Michigan (UM)
Exclusion
- Patients that do not report pain (i.e., score\<2) as they are less likely to benefit from VR-directed BGBT
- Patients with a history of conditions that could potentially be harmed by VR including seizures/epilepsy, loss of awareness, binocular vision loss, current pregnancy, or uncontrolled cardiac (e.g., arrhythmia, coronary artery disease) or neurological/cerebrovascular disease.
Key Trial Info
Start Date :
April 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06910787
Start Date
April 29 2025
End Date
October 1 2027
Last Update
May 7 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109