Virtual Reality (VR) -Directed Brain Gut Behavioral Treatment (BGBT) for Inflammatory Bowel Disease (IBD) Inpatients

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT06188793
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2023-12-18
• Study First Posted: 2024-01-03
• Study Start: 2024-02-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention measured as the frequency (percentage) of enrolled participants that complete the VR-directed BGBT inpatient program	3 days of treatment

Secondary Outcome Measures

Name	Time	Method
Acceptability using the System Usability Scale - patients	Day 3 (post intervention)	This is a 10-item question scale that are answered from a range from strongly agree to strongly disagree. Scores range from 0 to 100 with a higher score indicating greater acceptability.
Acceptability using the Treatment Acceptance and Adherence Scale- patients	Day 3 (post intervention)	This is a 10-item question scale that have a range from disagree strongly- agree strongly.; Scores range from 10-70 with higher scores indication greater acceptability.
Intervention acceptability based on qualitative data and collected from audio-recordings of semi-structured interview	1 week (semi-structured interview within 1 week of completion of the intervention)	Patient acceptability will be evaluated through semi-structured interviews within 1 week of completion of the intervention to understand satisfaction, expectations, and experiences with the protocol, including perceived benefits or harms, and barriers to use.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States