40 Participants Needed

Virtual Reality Therapy for Inflammatory Bowel Disease

SC
Overseen ByShirley Cohen-Mekelburg, MD, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
Must be taking: IBD-targeted treatment
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must be receiving IBD-targeted treatments like 5-aminosalicylates, thiopurines, biologics, or small molecules, so it seems you can continue these medications.

What data supports the effectiveness of the treatment VR-directed BGBT for Inflammatory Bowel Disease?

Research shows that virtual reality (VR) therapy can help manage pain and reduce mental distress in various conditions, such as burn rehabilitation and pain management. This suggests that VR-directed BGBT might also be effective in alleviating symptoms associated with Inflammatory Bowel Disease.12345

How is VR-directed BGBT treatment different from other treatments for inflammatory bowel disease?

VR-directed BGBT is unique because it uses virtual reality to create an immersive experience that can help relieve abdominal pain, which is a common symptom in disorders of gut-brain interaction. Unlike traditional treatments that may have side effects or provide incomplete relief, this approach leverages technology to potentially improve symptoms and quality of life without the need for medication.678910

What is the purpose of this trial?

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

Research Team

SC

Shirley Cohen-Mekelburg, MD, MS

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals with Inflammatory Bowel Disease (IBD) who are interested in a virtual reality-based therapy to manage pain. Specific eligibility criteria details were not provided, so participants should inquire about any additional requirements.

Inclusion Criteria

I can pick up and return VR equipment at UM.
I have had abdominal pain with an average severity of 2 or more in the last day.
I am an adult with IBD and am receiving treatment for it.
See 1 more

Exclusion Criteria

I do not experience significant pain.
I don't have conditions like epilepsy, severe heart issues, or pregnancy that VR could worsen.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week VR-directed BGBT program to enhance pain treatment for IBD

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of opioid requirements and healthcare utilization

4 weeks

Treatment Details

Interventions

  • VR-directed BGBT
Trial Overview The study tests if VR-directed Brain-gut Behavioral Therapies (BGBT) can help reduce pain and improve quality of life for IBD patients compared to standard treatment. Success will be measured by program completion rates and improvements in pain scores and health-related quality of life.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: VR-directed BGBTExperimental Treatment1 Intervention
Group II: Enhanced treatment as usual (E-TAU)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

American Gastroenterological Association

Collaborator

Trials
6
Recruited
4,400+

Findings from Research

Virtual reality (VR) rehabilitation significantly improves quality of life and work performance in burn patients, with a notable increase in range of motion (ROM) of joints (SMD=0.72) compared to usual rehabilitation methods.
VR interventions effectively reduce various aspects of pain (intensity, affective, and cognitive components) and lower anxiety levels during treatment, while also making rehabilitation more enjoyable, although they do not significantly enhance hand grip or pinch strength.
Use of Virtual Reality in Burn Rehabilitation: A Systematic Review and Meta-analysis.Lan, X., Tan, Z., Zhou, T., et al.[2023]
In a study involving 20 stroke survivors, multiuser virtual reality (MU VR) therapy led to significantly greater arm movement (414.6m) compared to single-user (SU VR) therapy (327.0m), indicating that MU VR may enhance physical engagement during rehabilitation.
Participants showed high compliance with both therapy modes (99% for MU and 89% for SU), and overall motor recovery, as measured by the Fugl-Meyer Assessment, improved significantly across all participants, suggesting that MU VR can effectively extend clinical therapy into home settings.
Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial.Thielbar, KO., Triandafilou, KM., Barry, AJ., et al.[2020]
Virtual reality (VR) therapies have shown promise in effectively distracting patients from both acute and chronic pain, suggesting a new approach to pain management beyond traditional methods like opioids and physical therapy.
Clinical studies indicate that VR can be beneficial for various pain conditions, including fibromyalgia and phantom limb pain, by immersing patients in interactive environments that reduce their perception of pain.
Virtual Reality as a Clinical Tool for Pain Management.Pourmand, A., Davis, S., Marchak, A., et al.[2018]

References

Use of Virtual Reality in Burn Rehabilitation: A Systematic Review and Meta-analysis. [2023]
Effect of Time-Dose-Matched Virtual Reality Therapy on Upper Limb Dysfunction in Patients Poststroke: A Meta-Analysis of Randomized Controlled Trials. [2022]
Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. [2020]
Virtual Reality as a Clinical Tool for Pain Management. [2018]
Addressing virtual reality misclassification: A hardware-based qualification matrix for virtual reality technology. [2021]
Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? [2023]
Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. [2023]
Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome. [2023]
Computational postprocessing quantification of small bowel motility using magnetic resonance images in clinical practice: An initial experience. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Global small bowel motility: assessment with dynamic MR imaging. [2022]
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