15 Participants Needed

Virtual Reality for Abdominal Pain in Crohn's Disease

LP
Overseen ByLauren P Loeb, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using opioids, you will not be eligible to participate.

What data supports the effectiveness of the treatment Virtual Reality Therapy for abdominal pain in Crohn's Disease?

Research shows that virtual reality (VR) therapy can help reduce pain in various conditions, including chronic pain and cancer-related pain. In studies, VR therapy improved pain outcomes in most cases, suggesting it might also help with abdominal pain in Crohn's Disease.12345

Is Virtual Reality Therapy safe for people with Crohn's Disease?

A pilot study on Mindfulness-Based Virtual Reality (MBVR) for children and young adults with Inflammatory Bowel Disease, including Crohn's Disease, found it to be safe and well-received, with participants reporting high satisfaction and no adverse effects.678910

How is Virtual Reality Therapy different from other treatments for abdominal pain in Crohn's disease?

Virtual Reality Therapy is unique because it uses immersive technology to help manage pain and anxiety, offering a non-drug, enjoyable, and relaxing experience that can be used in medical settings or daily life, unlike traditional medication-based treatments.611121314

What is the purpose of this trial?

The purpose of this research is to see if patients with Crohn's disease (CD) and abdominal pain resulting in health-related quality of life deficits despite lack of evidence of active inflammation improve with the use of virtual reality (VR).

Research Team

JK

Jami Kinnucan, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with Crohn's disease who are not currently experiencing active inflammation but suffer from abdominal pain that affects their quality of life. The specific eligibility criteria to join the study have not been provided.

Inclusion Criteria

I have Crohn's disease with low inflammation levels and weekly abdominal pain.

Exclusion Criteria

I have symptoms of a pelvic floor disorder.
I am currently using opioids for pain management.
I have symptoms that suggest a physical illness.
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Timeline

Pre-screening

Participants undergo a two-week pre-screening evaluation for symptoms through questionnaires

2 weeks

Treatment

Participants use a VR headset daily for at least 30 minutes over 8 weeks

8 weeks
Weekly calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • Virtual Reality
Trial Overview The study is testing whether a VR headset can help relieve abdominal pain in patients with quiescent Crohn's disease, aiming to improve their health-related quality of life.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: VR HeadsetExperimental Treatment1 Intervention

Virtual Reality is already approved in United States for the following indications:

🇺🇸
Approved in United States as Virtual Reality Therapy for:
  • Functional Dyspepsia
  • Irritable Bowel Syndrome (IBS)
  • Gastroparesis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

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]
A systematic review of 46 studies involving 1456 participants found that virtual, augmented, or mixed reality (VR/AR/MR) technology improved pain-related outcomes in 78% of randomized controlled trials (RCTs) for individuals with chronic pain.
Most positive effects were observed immediately or up to one month after treatment, highlighting the need for further RCTs to evaluate long-term benefits and accessibility for those facing pain management disparities.
Use and efficacy of virtual, augmented, or mixed reality technology for chronic pain: a systematic review.Matthie, NS., Giordano, NA., Jenerette, CM., et al.[2023]
A systematic review of 122 randomized controlled trials involving 9,138 patients found that virtual reality (VR) significantly reduces pain, with a standardized mean difference of -0.65, indicating a strong effect across various types of pain, including acute, chronic, and procedural.
The effectiveness of VR in pain management was particularly notable in younger patients and those experiencing moderate to severe pain, suggesting that VR could be a valuable tool for these groups, although the studies showed considerable variability and moderate to high risk of bias.
Effect modifiers of virtual reality in pain management: a systematic review and meta-regression analysis.Lier, EJ., de Vries, M., Steggink, EM., et al.[2023]

References

Virtual Reality as a Clinical Tool for Pain Management. [2018]
Use and efficacy of virtual, augmented, or mixed reality technology for chronic pain: a systematic review. [2023]
Effect modifiers of virtual reality in pain management: a systematic review and meta-regression analysis. [2023]
Virtual reality for improving pain and pain-related symptoms in patients with advanced stage colorectal cancer: A pilot trial to test feasibility and acceptability. [2022]
Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. [2020]
Mindfulness-Based Virtual Reality Intervention for Children and Young Adults with Inflammatory Bowel Disease: A Pilot Feasibility and Acceptability Study. [2021]
Crohn's disease patients' risk-benefit preferences: serious adverse event risks versus treatment efficacy. [2022]
Heterogeneity in Definitions of Efficacy and Safety Endpoints for Clinical Trials of Crohn's Disease: A Systematic Review. [2019]
Adverse events in IBD: to stop or continue immune suppressant and biologic treatment. [2023]
A prospective study comparing patient-reported outcomes in Crohn's disease. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Simple pain measures reveal psycho-social pathology in patients with Crohn's disease. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Cannabis induces a clinical response in patients with Crohn's disease: a prospective placebo-controlled study. [2022]
Interventions for the management of abdominal pain in Crohn's disease and inflammatory bowel disease. [2023]
Pain management in inflammatory bowel disease: feasibility of an online therapist-supported CBT-based self-management intervention. [2021]
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