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Active Not Recruiting
NCT06910787
Outpatient VR (Virtual Reality)-Brain-gut Behavioral Therapies (BGBT) in Inflammatory Bowel Disease (IBD)
Conditions: Inflammatory Bowel Diseases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: University of Michigan
Location: University of Michigan Ann Arbor Michigan
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 hypothesis include:
* the study will achieve greater than 75% program completion and 75% study assessment completion
* patients with IBD will find VR-directed BGBT acceptable as an outpatient pain treatment
* outpatient VR-directed BGBT in IBD arm participants will report a greater reduction in pain scores, symptom burden, stress, depression, anxiety, and pain-related interference and an improvement in health-related quality of life
* will have lower opioid requirements and healthcare utilization at 4-weeks follow-up compared to the E-TAU arm
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* Patients that do not report pain (i.e., score\
Source: ClinicalTrials.gov (NCT06910787). StuddyBuddy aggregates publicly available trial information.