Virtual Reality (VR) -Directed Brain Gut Behavioral Treatment (BGBT) for Inflammatory Bowel Disease (IBD) Inpatients
NCT ID: NCT06188793
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-02-13
2026-05-31
Brief Summary
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The study hypothesizes that:
* At least 75% of enrolled participants will complete the VR-directed BGBT inpatient program
* Hospitalized patients with IBD will find VR-directed BGBT acceptable as a pain treatment option in the inpatient setting.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Virtual reality-directed BGBT
Virtual reality-directed BGBT
Enrolled participants will receive up to 3-days of VR-directed BGBT through several modules including distraction games, mindfulness meditation, breathing exercises, and cognitive behavioral therapy based coaching. Participants will complete questionnaires at various time points and be asked to complete a semi-structured interview post-intervention.
Interventions
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Virtual reality-directed BGBT
Enrolled participants will receive up to 3-days of VR-directed BGBT through several modules including distraction games, mindfulness meditation, breathing exercises, and cognitive behavioral therapy based coaching. Participants will complete questionnaires at various time points and be asked to complete a semi-structured interview post-intervention.
Eligibility Criteria
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Inclusion Criteria
* Hospitalized for management of IBD (inpatient medicine services at Michigan Medicine)
Exclusion Criteria
* Anticipated length of hospital stay is less than 72 hours
* Patients that have previously had a seizure, loss of awareness, or other symptoms linked to an epileptic condition
* Patients with binocular vision loss
* Patients with an uncontrolled cardiac condition such as an arrhythmia, coronary artery disease, or neurological/cerebrovascular disease.
* Patients that are currently pregnant
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Shirley Cohen-Mekelburg
Assistant Professor
Principal Investigators
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Shirley Cohen-Mekelburg, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Gutermuth B, Jordan A, Hodish G, Sturgeon JA, DeJonckheere M, Berinstein JA, Sheehan J, Bishu S, Higgins PD, Cohen-Mekelburg S. Evaluation of a virtual reality-directed brain-gut behavioural treatment inpatient program for patients with inflammatory bowel disease: protocol for a pilot feasibility trial. BMJ Open. 2025 Jul 3;15(7):e098674. doi: 10.1136/bmjopen-2024-098674.
Other Identifiers
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HUM00240999
Identifier Type: -
Identifier Source: org_study_id
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