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Active (not recruiting) Not applicable NCT06910787

Outpatient VR (Virtual Reality)-Brain-gut Behavioral Therapies (BGBT) in Inflammatory Bowel Disease (IBD)

No applicable phase (e.g. observational)
Conditions: Inflammatory Bowel Diseases

Sponsor: University of Michigan

trial.available_in: БГ
Overview
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
Who can participate
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\<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.
Interventions
VR-directed BGBT
DEVICE
E-TAU
OTHER
Locations 1
United States (1)
University of Michigan
Ann Arbor , Michigan
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
29.04.2025
Completion date
01.10.2027
Registry ID
NCT06910787
Source
clinicaltrials.gov
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