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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual reality (VR) therapy can help manage pain for people hospitalized with inflammatory bowel disease (IBD). Researchers aim to determine if VR therapy, which uses technology to create a simulated environment, is both practical and well-received by patients experiencing pain from IBD while in the hospital. Suitable participants should have IBD, be experiencing pain, and be hospitalized for at least three days. As an unphased trial, this study offers patients the opportunity to explore innovative pain management techniques using VR technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual reality therapy is safe for patients with inflammatory bowel disease?

Research has shown that virtual reality-directed brain-gut behavioral therapy (VR-directed BGBT) is generally well-tolerated by patients. Studies have primarily assessed the practicality and acceptability of this therapy for easing pain in individuals with inflammatory bowel disease (IBD). So far, no major safety issues have been reported.

However, some sources mention possible risks, such as no improvement in IBD symptoms or the emergence of new symptoms from using the VR technology. This study phase does not focus on safety, so detailed safety information might be limited. The testing of VR-directed BGBT suggests that earlier studies have found it reasonably safe for individuals.12345

Why are researchers excited about this trial?

Virtual Reality (VR)-Directed Brain Gut Behavioral Treatment (BGBT) is unique because it leverages virtual reality technology to address the brain-gut connection in inflammatory bowel disease (IBD), which is a novel approach compared to traditional treatments like medication and dietary changes. Most current treatments focus on alleviating physical symptoms and inflammation, but VR-directed BGBT aims to influence the brain's role in symptom management, potentially reducing stress and improving overall gut health. Researchers are excited because this method could offer a non-invasive, drug-free option that improves quality of life by targeting the psychological and neurological aspects of IBD, offering a new dimension to patient care.

What evidence suggests that virtual reality-directed brain-gut behavioral therapy is effective for inflammatory bowel disease?

Research has shown that virtual reality (VR) for brain-gut therapy might help manage pain in people with inflammatory bowel disease (IBD). Early results suggest that patients in hospitals find this therapy practical and well-received. Studies indicate that over 75% of participants complete the VR program, demonstrating its ease of use and perceived benefits. This trial will evaluate the effectiveness of Virtual Reality-Directed Brain Gut Behavioral Therapy (BGBT) in helping patients focus on the brain-gut connection, which may reduce their pain. While more research is needed, these early findings offer promise for those seeking new ways to manage IBD pain.12367

Who Is on the Research Team?

SC

Shirley Cohen-Mekelburg, MD, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for hospitalized patients with Inflammatory Bowel Disease (IBD) who are interested in trying a new pain treatment. The study will test if a Virtual Reality (VR)-directed therapy can help manage their pain while they're in the hospital.

Inclusion Criteria

I have Inflammatory Bowel Disease and experience pain.
Hospitalized for management of IBD (inpatient medicine services at Michigan Medicine)

Exclusion Criteria

I do not have uncontrolled heart or brain conditions.
Patients that are currently pregnant
Patients with binocular vision loss
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo VR-directed brain-gut behavioral therapy (BGBT) as a pain treatment option during hospitalization

3 days
Inpatient setting

Follow-up

Participants are monitored for acceptability and satisfaction with the VR-directed BGBT through interviews and scales

1 week
1 visit (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Virtual Reality (VR) -Directed Brain Gut Behavioral Treatment (BGBT)
Trial Overview The intervention being studied is a VR-directed brain-gut behavioral therapy (BGBT). It's designed to see if using VR technology can be an effective way to treat pain for IBD patients during their hospital stay.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Virtual reality-directed BGBTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Published Research Related to This Trial

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]
In a randomized crossover trial involving 50 cancer patients undergoing chemotherapy, Virtual Reality (VR) significantly improved mood states compared to Guided Imagery (GI), indicating its potential as a beneficial intervention for emotional well-being during treatment.
The VR intervention also led to statistically significant improvements in biophysical parameters like blood pressure and heart rate, although it did not show effectiveness in reducing symptoms of nausea, pain, or feeling sick.
Effectiveness of Virtual Reality Vs Guided Imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial.Ioannou, A., Paikousis, L., Papastavrou, E., et al.[2022]
Virtual reality (VR) has been shown to be an effective tool for managing acute pain, with 83% of the studies reviewed reporting decreased pain intensity when using VR compared to non-VR methods.
The effectiveness of VR in pain management is likely due to its ability to distract patients, highlighting the importance of creating immersive and engaging VR experiences to enhance therapeutic outcomes.
A Systematic Review of Virtual Reality Therapeutics for Acute Pain Management.Dreesmann, NJ., Su, H., Thompson, HJ.[2023]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40615149/
Evaluation of a virtual reality-directed brain-gut behavioural ...In this study, we aim to establish feasibility and acceptability for a VR-directed BGBT inpatient programme for patients with IBD.
NCT06188793 | Virtual Reality (VR) -Directed Brain Gut ...The research is studying virtual reality (VR)-directed brain-gut behavioral therapy (BGBT) as a pain treatment option for hospitalized patients with ...
Evaluation of a virtual reality-directed brain-gut behavioural ...In this study, we aim to establish feasibility and acceptability for a VR-directed BGBT inpatient programme for patients with IBD.
NCT06910787 | Outpatient VR (Virtual Reality)-Brain-gut ...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 ...
Evaluation of a virtual reality-directed brain-gut behavioural ...virtual reality (VR) in hospitalized patients with inflammatory bowel disease (IBD). The study addresses an important clinical problem: challenges in pain.
Outpatient VR (Virtual Reality)-Brain-gut Behavioral ...This research study is being done to learn if a virtual reality (VR)-directed BGBT program is feasible and acceptable for patients to ...
UNIVERSITY OF MICHIGAN CONSENT TO BE PART OF ...For this study, some of these risks may include no improvement of your current inflammatory bowel disease, or new symptoms from use of the virtual reality ...
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