Inflammatory Bowel Diseases
Conditions
Keywords
Virtual reality, Inpatient, Pain, Brain Gut Behavioral Treatment
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.
Interventions
DEVICEVirtual 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.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
CONTACTShirley Cohen-Mekelburg, MD, MS
PRINCIPAL_INVESTIGATORShirley Cohen-Mekelburg, MD, MS
University of Michigan
Outcome results
None listed