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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality-directed BGBT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality-directed BGBT | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the intervention measured as the frequency (percentage) of enrolled participants that complete the VR-directed BGBT inpatient program | 3 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention acceptability based on qualitative data and collected from audio-recordings of semi-structured interview | 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. | 1 week (semi-structured interview within 1 week of completion of the intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shirley Cohen-Mekelburg, MD, MS | Contact | 734-845-5735 | shcohen@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shirley Cohen-Mekelburg, MD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40615149 | Derived | 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. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Acceptability using the System Usability Scale - patients | 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. | Day 3 (post intervention) |
| Acceptability using the Treatment Acceptance and Adherence Scale- patients | 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. | Day 3 (post intervention) |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |