Virtual Reality for Abdominal Pain in Crohn's Disease

Overseen By Lauren P Loeb, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Opioids

Disqualifiers: Seizure disorder, Visual impairments, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

15 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{6 11 12 13 14}

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

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.

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

Group I: VR Headset Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The study demonstrated that a 30-minute virtual reality session in an underwater environment significantly reduced pain by 59% and improved relaxation, tension, stress, anxiety, and mood in 20 patients with advanced colorectal cancer, indicating its potential as a non-pharmacological pain management tool.

All participants completed the VR session without significant side effects, showing high satisfaction (83%), which supports the feasibility and safety of using virtual reality for pain relief in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for improving pain and pain-related symptoms in patients with advanced stage colorectal cancer: A pilot trial to test feasibility and acceptability. Kelleher, SA., Fisher, HM., Winger, JG., et al.[2022]

In a case series involving 10 chronic pain patients, 5 reported reduced pain during virtual reality (VR) therapy sessions, suggesting potential short-term benefits of VR for pain management.

While VR therapy did not show significant overall changes in pain scores after treatment, it was safe with no serious adverse events, although 60% of participants experienced some cybersickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. Garrett, B., Taverner, T., McDade, P.[2020]

A pilot study involving 62 children and young adults with Inflammatory Bowel Disease (IBD) showed that a Mindfulness-Based Virtual Reality (MBVR) intervention was highly feasible and acceptable, with participants reporting high satisfaction and relaxation levels after the 6-minute session.

Preliminary results indicated that MBVR significantly reduced anxiety and pain in participants, suggesting it could be an effective complementary approach for managing psychological and physical symptoms associated with IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Virtual Reality Intervention for Children and Young Adults with Inflammatory Bowel Disease: A Pilot Feasibility and Acceptability Study. Wren, AA., Neiman, N., Caruso, TJ., et al.[2021]

Patients with Crohn's disease are willing to accept a certain level of life-threatening adverse event risks, such as serious infections or lymphoma, in exchange for significant symptom relief, indicating a clear preference for treatment efficacy over safety.

The study found that daily symptom severity was the most important factor influencing treatment choices, with patients willing to accept a maximum acceptable annual risk of 0.69% to 0.81% for serious adverse events when moving from severe symptoms to remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crohn's disease patients' risk-benefit preferences: serious adverse event risks versus treatment efficacy. Johnson, FR., Ozdemir, S., Mansfield, C., et al.[2022]

A systematic review of 116 randomized controlled trials involving 27,263 patients with Crohn's disease revealed significant variability in how clinical response and remission are defined, highlighting the need for standardized outcome measures in future studies.

Safety outcomes were consistently reported across most trials (over 85%), indicating a strong focus on patient safety in the evaluation of treatments for Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heterogeneity in Definitions of Efficacy and Safety Endpoints for Clinical Trials of Crohn's Disease: A Systematic Review. Ma, C., Hussein, IM., Al-Abbar, YJ., et al.[2019]

The review highlights that while treatments for Crohn's disease and ulcerative colitis, such as azathioprine, mercaptopurine, methotrexate, and biologic therapies, can be effective, they are associated with a range of adverse events, including serious complications like infections and malignancies.

It emphasizes the importance of gastroenterologists communicating the risks and benefits of these therapies to patients, and provides strategies for discussing when it may be appropriate to modify or discontinue treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in IBD: to stop or continue immune suppressant and biologic treatment. McLean, LP., Cross, RK.[2023]

The Bristol Stool Form Scale (BSFS) showed a stronger correlation with clinical activity in Crohn's disease patients compared to the visual analog scale (VAS) for abdominal pain, indicating it may be a more effective measure for monitoring disease status.

Both BSFS and VAS demonstrated moderate to high responsiveness in tracking changes in Crohn's disease, suggesting they are valid tools for assessing patient-reported outcomes during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study comparing patient-reported outcomes in Crohn's disease. Hoekman, DR., Löwenberg, M., van den Brink, GR., et al.[2022]

In a study of 594 adult Crohn's disease patients, pain severity was significantly linked to various psycho-social factors, including female gender, low socio-economic status, and psychological stress, indicating that pain management should consider these associations.

Patients with greater life satisfaction reported less pain, suggesting that improving psychological well-being may help alleviate pain in Crohn's disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simple pain measures reveal psycho-social pathology in patients with Crohn's disease. Odes, S., Friger, M., Sergienko, R., et al.[2018]

In a study of 21 patients with Crohn's disease who did not respond to standard treatments, those receiving THC-rich cannabis showed a significant clinical response, with 90% experiencing a decrease in disease activity compared to 40% in the placebo group.

While the primary goal of achieving complete remission was not met, 45% of patients in the cannabis group achieved remission, and the treatment was associated with improved appetite and sleep without significant side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis induces a clinical response in patients with Crohn's disease: a prospective placebo-controlled study. Naftali, T., Bar-Lev Schleider, L., Dotan, I., et al.[2022]

A systematic review of 14 studies involving 743 participants found low certainty evidence that transcranial direct current stimulation may help reduce abdominal pain intensity in Crohn's disease compared to sham stimulation.

Overall, the review could not determine the efficacy of most interventions for managing abdominal pain in Crohn's disease due to low participant numbers and high variability among studies, indicating a need for more robust research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for the management of abdominal pain in Crohn's disease and inflammatory bowel disease. Sinopoulou, V., Gordon, M., Akobeng, AK., et al.[2023]

A 9-week online cognitive behavioral therapy (CBT) program for individuals with chronic pain related to inflammatory bowel disease (IBD) was found to be feasible and acceptable, with 85% of participants engaging in the sessions and 55% completing at least 5 out of 9 sessions.

Participants reported improvements in quality of life and pain self-efficacy, along with reductions in depression, anxiety, and pain-related distress, indicating that this tailored CBT intervention could be beneficial for managing chronic IBD-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management in inflammatory bowel disease: feasibility of an online therapist-supported CBT-based self-management intervention. Sweeney, L., Moss-Morris, R., Czuber-Dochan, W., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Use and efficacy of virtual, augmented, or mixed reality technology for chronic pain: a systematic review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effect modifiers of virtual reality in pain management: a systematic review and meta-regression analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Virtual Reality Intervention for Children and Young Adults with Inflammatory Bowel Disease: A Pilot Feasibility and Acceptability Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Crohn's disease patients' risk-benefit preferences: serious adverse event risks versus treatment efficacy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Heterogeneity in Definitions of Efficacy and Safety Endpoints for Clinical Trials of Crohn's Disease: A Systematic Review. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events in IBD: to stop or continue immune suppressant and biologic treatment. [2023]

10. England pubmed.ncbi.nlm.nih.gov

A prospective study comparing patient-reported outcomes in Crohn's disease. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Simple pain measures reveal psycho-social pathology in patients with Crohn's disease. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Cannabis induces a clinical response in patients with Crohn's disease: a prospective placebo-controlled study. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Interventions for the management of abdominal pain in Crohn's disease and inflammatory bowel disease. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Pain management in inflammatory bowel disease: feasibility of an online therapist-supported CBT-based self-management intervention. [2021]