Outpatient Virtual Reality-Directed Treatment for Pain in Inflammatory Bowel Disease

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Shirley Cohen-Mekelburg, MD, MS
shcohen@med.umich.edu
734-845-5735
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2027-10
Participants
Target number of participants: 40
Treatments
Experimental: VR-directed BGBT
Active_comparator: Enhanced treatment as usual (E-TAU)
Related Therapeutic Areas
Sponsors
Collaborators: American Gastroenterological Association
Leads: University of Michigan

This content was sourced from clinicaltrials.gov