Recruiting

VR-directed BGBT

Sponsor:

University of Michigan

Code:

NCT06188793

Conditions

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual reality-directed BGBT

Study Details

Brief summary:

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.

Conditions

Inflammatory Bowel Diseases

Study ID

NCT06188793

Start date

Feb 13, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual reality-directed BGBT

Interventions

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.

Primary outcome measure

  • Feasibility of the intervention measured as the frequency (percentage) of enrolled participants that complete the VR-directed BGBT inpatient program [ Time Frame: 3 days of treatment ]

Central Contacts and Locations

Central contacts

Shirley Cohen-Mekelburg, MD, MS

734-845-5735shcohen@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Shirley Cohen-Mekelburg, MD, MS

734-845-5735shcohen@med.umich.edu

Principal Investigator:

Shirley Cohen-Mekelburg, MD, MS

More Information

Sponsor

University of Michigan

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Virtual reality
  • Inpatient
  • Pain
  • Brain Gut Behavioral Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-23.