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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-13

Study Completion Date

2026-05-31

Brief Summary

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The research is studying virtual reality (VR)-directed brain-gut behavioral therapy (BGBT) as a pain treatment option for hospitalized patients with inflammatory bowel disease (IBD). This study is being done to learn if VR-directed BGBT is feasible and acceptable for patients with IBD in addressing pain in the hospital setting.

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.

Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual reality-directed BGBT

Group Type EXPERIMENTAL

Virtual reality-directed BGBT

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with Inflammatory Bowel Disease and self-reported pain
* Hospitalized for management of IBD (inpatient medicine services at Michigan Medicine)

Exclusion Criteria

* Patients that do not report pain
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Shirley Cohen-Mekelburg

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shirley Cohen-Mekelburg, MD, MS

Role: CONTACT

734-845-5735

Facility Contacts

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Shirley Cohen-Mekelburg, MD, MS

Role: primary

734-845-5735

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.

Reference Type DERIVED
PMID: 40615149 (View on PubMed)

Other Identifiers

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HUM00240999

Identifier Type: -

Identifier Source: org_study_id

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