Virtual Reality for Abdominal Pain in Crohn's Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Must not be taking: Opioids
Disqualifiers: Seizure disorder, Visual impairments, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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).
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.
12345Is 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.
678910How 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.
611121314Eligibility 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.
+5 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Mayo Clinic FloridaJacksonville, FL
Loading ...
Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Virtual Reality as a Clinical Tool for Pain Management. [2018]To evaluate the use of virtual reality (VR) therapies as a clinical tool for the management of acute and chronic pain.
Use and efficacy of virtual, augmented, or mixed reality technology for chronic pain: a systematic review. [2023]Aim: Characterize use and efficacy/effectiveness of virtual, augmented, or mixed reality (VR/AR/MR) technology as non-pharmacological therapy for chronic pain. Methods: Systematic search of 12 databases to identify empirical studies, of individuals who experience chronic pain or illness involving chronic pain, published between 1990 and 2021. JBI Critical Appraisal Checklists assessed study bias and a narrative synthesis was provided. Results: 46 studies, investigating a total of 1456 participants and including 19 randomized controlled trials (RCT), were reviewed. VR/AR/MR was associated with improved pain-related outcomes in 78% of the RCTs. Conclusion: While most studies showed effects immediately or up to one month post treatment, RCTs are needed to further evaluate VR/AR/MR, establish long-term benefits, and assess accessibility, especially among individuals who experience pain management disparities.
Effect modifiers of virtual reality in pain management: a systematic review and meta-regression analysis. [2023]There is a rapidly growing body of evidence for the application of virtual reality (VR) in pain management, however, with varying effectiveness. Little is known about patient-related and VR-related factors affecting efficacy of VR. A systematic review and meta-analysis was performed including 122 randomised controlled trials (9138 patients), reporting on subjectively reported pain scores comparing an immersive VR intervention to a non-VR control group. Virtual reality significantly reduced pain in the pooled analysis (standardized mean difference = -0.65, 95% CI -0.76 to -0.54, P
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 (VR) has the potential to improve pain and pain-related symptoms. We examined the feasibility, acceptability, safety, and impact of a 30-min virtual underwater/sea environment (VR Blue) for reducing pain and pain-related symptoms in advanced colorectal cancer patients. A qualitative exit interview was conducted to understand preferences, thoughts, and feelings about the VR session.
Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. [2020]Virtual reality (VR) therapy has been successfully used as an adjunct therapy for the management of acute pain in adults and children, and evidence of potential efficacy in other health applications is growing. However, minimal research exists on the value of VR as an intervention for chronic pain.
Mindfulness-Based Virtual Reality Intervention for Children and Young Adults with Inflammatory Bowel Disease: A Pilot Feasibility and Acceptability Study. [2021]The aim of this pilot study was to assess: (1) the feasibility and acceptability of a Mindfulness-Based Virtual Reality (MBVR) intervention among children and young adults with Inflammatory Bowel Disease (IBD), and (2) the preliminary efficacy of MBVR on key psychological (anxiety) and physical (pain) outcomes. Participants were 62 children to young adults with IBD (M = 15.6 years; 69.4% Crohn's disease; 58% male) recruited from an outpatient pediatric IBD clinic. Participants completed a baseline assessment, underwent the 6-min MBVR intervention, completed a post-intervention assessment and study satisfaction survey, and provided qualitative feedback. Results suggest strong feasibility and acceptability. Participants reported high levels of satisfaction with MBVR including high levels of enjoyment (M = 4.38; range 1-5) and relaxation (M = 4.35; range 1-5). Qualitative data revealed several key themes including participants interest in using MBVR in IBD medical settings (e.g., hospitalizations, IBD procedures, IBD treatments), as well as in their daily lives to support stress and symptom management. Preliminary analyses demonstrated improvements in anxiety (t = 4.79, p = 0.001) and pain (t = 3.72, p < 0.001) following MBVR. These findings provide initial support for the feasibility and acceptability of MBVR among children and young adults with IBD. Results also suggest MBVR may improve key IBD outcomes (e.g., anxiety, pain) and highlight the importance of conducting a randomized controlled trial and more rigorous research to determine intervention efficacy.
Crohn's disease patients' risk-benefit preferences: serious adverse event risks versus treatment efficacy. [2022]Regulatory assessments of drug risks do not routinely consider patient preferences, despite evidence that some patients are willing to accept increased side-effect risk in exchange for therapeutic benefits. The aim of this study is to estimate the willingness of Crohn's disease (CD) patients to accept life-threatening adverse event risks in exchange for CD symptom relief.
Heterogeneity in Definitions of Efficacy and Safety Endpoints for Clinical Trials of Crohn's Disease: A Systematic Review. [2019]Endpoints in randomized controlled trials (RCTs) of Crohn's disease (CD) are changing. We performed a systematic review of efficacy and safety outcomes reported in placebo-controlled RCTs of patients with CD.
Adverse events in IBD: to stop or continue immune suppressant and biologic treatment. [2023]Crohn's disease and ulcerative colitis affect an increasing number of patients. A variety of medical options exist for the treatment of these diseases including immune suppressants and biologic therapies. Unfortunately, these agents are associated with adverse events ranging from mild nuisance symptoms to potentially life-threatening complications including infections and malignancies. This review discusses adverse events associated with azathioprine, mercaptopurine, and methotrexate as well as anti-TNF-α and anti-integrin antibodies. In addition, adverse events associated with combination therapy are discussed as are clinical scenarios in which it may be reasonable to discontinue or de-escalate drug therapy. It is the responsibility of the treating gastroenterologist to effectively communicate the benefits and risks of therapy with patients; this review offers strategies that may assist providers in communicating risk with patients in addition to offering our perspective on whether modification or cessation of therapy can be considered.
A prospective study comparing patient-reported outcomes in Crohn's disease. [2022]Patient reported outcomes are important in Crohn's disease. In this prospective cohort, we investigated the performance of the Bristol Stool Form Scale (BSFS) and a visual analog scale (VAS) for abdominal pain as outcome measures in Crohn's disease.
Simple pain measures reveal psycho-social pathology in patients with Crohn's disease. [2018]To determine whether pain has psycho-social associations in adult Crohn's disease (CD) patients.
Cannabis induces a clinical response in patients with Crohn's disease: a prospective placebo-controlled study. [2022]The marijuana plant Cannabis sativa has been reported to produce beneficial effects for patients with inflammatory bowel diseases, but this has not been investigated in controlled trials. We performed a prospective trial to determine whether cannabis can induce remission in patients with Crohn's disease.
Interventions for the management of abdominal pain in Crohn's disease and inflammatory bowel disease. [2023]Crohn's disease is a remitting and relapsing disorder that can affect the whole gastrointestinal tract. Active disease symptoms include abdominal pain, fatigue, weight loss, and diarrhoea. There is no known cure; however, the disease can be managed, and therefore places a huge financial burden on healthcare systems. Abdominal pain is a common and debilitating symptom of Crohn's and other inflammatory bowel diseases (IBDs), and is multifaceted. Abdominal pain in Crohn's disease could be a symptom of disease relapse or related to medication adverse effects, surgical complications and strictures or adhesions secondary to IBD. In the absence of these factors, around 20 to 50% of people with Crohn's in remission still experience pain.
Pain management in inflammatory bowel disease: feasibility of an online therapist-supported CBT-based self-management intervention. [2021]Chronic pain is a poorly managed symptom of inflammatory bowel disease (IBD). Cognitive behavioural therapy (CBT) has an evidence base in functional gastrointestinal conditions and chronic pain. This study aimed to test the feasibility and acceptability of a 9-week online facilitator-supported CBT intervention, tailored for people with chronic IBD-related pain.