This research study is being done to learn if a virtual reality (VR)-directed BGBT program is feasible and acceptable for patients to enhance pain treatment for patients with IBD. The study hypothesis include: * the study will achieve greater than 75% program completion and 75% study assessment completion * patients with IBD will find VR-directed BGBT acceptable as an outpatient pain treatment * outpatient VR-directed BGBT in IBD arm participants will report a greater reduction in pain scores, symptom burden, stress, depression, anxiety, and pain-related interference and an improvement in health-related quality of life * will have lower opioid requirements and healthcare utilization at 4-weeks follow-up compared to the E-TAU arm
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
VR-directed BGBT using the Oculus Meta Quest 3 VR headset will be delivered using the Synergi application. The program includes 4-weeks of daily self-led activities using 5 virtual modules: (1) education (2) two interactive games (3) breathing exercises (4) gut-directed meditation and (5) gastroenterology-specific Cognitive behavioral therapy (CBT). Participants will also receive standard care. On day 1, intervention arm participants will undergo a brief in-person or virtual (i.e., zoom or Microsoft teams) training with study staff to learn how to use the VR headset and access intervention modules. On day 1 participants will be asked to explore each of the program modules to achieve initial familiarity. Participants will be encouraged to use the VR-BGBT program for at least 15 minutes daily, but at minimum 3-4 days each week. Additionally, study assessments will be completed at baseline, 2-weeks, 4-weeks, and 8-weeks, with an interview within 1-2 weeks of completing the program.
Participants will receive standard of care, as directed by the participant's gastroenterologist. Participants will also receive an educational video and fact sheet on pain in IBD. This will be 4-weeks with study assessments at baseline, 2-weeks, and 4-weeks, 8-weeks.
University of Michigan
Ann Arbor, Michigan, United States
Feasibility defined by the proportion of enrolled participants that complete the 4-week VR-directed BGBT program and study assessments.
The study team hypothesizes the study will achieve greater than 75% program completion and 75% study assessment completion.
Time frame: 4 weeks
Acceptability of VR-directed BGBT based on a semi-structured post intervention interview
The interview will be done to understand the participants' experience with the VR-directed BGBT intervention and conducted using interview guides with open-ended questions. interview guides will focus on four main domains related to participant's pain history, experience with VR-directed BGBT (including tolerability and acceptability of each BGBT module), perceived impact (including information on any components that were perceived to be most helpful or ineffective), and suggested improvements for program refinement.
Time frame: 4 weeks
VR-BGBT acceptability using the Treatment Acceptability and Adherence Scale
This is a 10-question scale that participants choose from 1 (disagree strongly) - 7 (agree strongly). Scores range from 10-70 with higher scores indication greater acceptability.
Time frame: 4 weeks
VR-BGBT usability using the System Usability Scale
This is a 10-question scale that participants choose from 1 (strongly agree) - 5 (strongly disagree). Scores range from 0 to 100 with a higher score indicating greater acceptability.
Time frame: 4 weeks
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