Using virtual reality to treat abdominal pain in Crohn's disease
A Pilot Study to Assess the Safety, Tolerability, and Efficacy of Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohn's Disease
This study is testing if using virtual reality can help adults with Crohn's disease feel less abdominal pain and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06647615 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the safety, tolerability, and efficacy of virtual reality (VR) therapy for adults with Crohn's disease who experience abdominal pain despite having no active inflammation. Participants will undergo a two-week pre-screening evaluation followed by an 8-week VR intervention, where they will use a VR headset daily for at least 30 minutes. The study will collect demographic information and assess changes in symptoms and quality of life through questionnaires. The goal is to determine if VR can help alleviate pain and improve overall well-being in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with confirmed Crohn's disease who experience weekly abdominal pain but have normal inflammatory markers.
Not a fit: Patients with active inflammation, significant psychological distress, or those unable to participate in the VR program may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive and innovative treatment option for managing abdominal pain in patients with Crohn's disease.
How similar studies have performed: While the use of virtual reality in medical treatment is gaining interest, this specific application for Crohn's disease is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a diagnosis of endoscopically and histologically confirmed CD with evidence of C-reactive protein \< 5 mg/dL and fecal calprotectin \< 150microg/g who also report any abdominal pain at least weekly will be included. Exclusion Criteria: * Patients will be excluded from the study if they do not have biopsy-proven CD, have a known seizure disorder, if symptoms are thought to represent an organic disorder, those with visual or hearing impairments, if symptoms represent a known pelvic floor disorder, if the patient is using opioids, has significant ongoing psychological distress (HAD score \> 11 for either anxiety or depression), or if the patient can not actively participate in the study for any other reason (e.g., inability to understand English as the VR program as an English only).
Where this trial is running
Jacksonville, Florida
- Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Jami Kinnucan, MD — Mayo Clinic
- Study coordinator: Lauren P Loeb, MD
- Email: loeb.lauren@mayo.edu
- Phone: 904-953-6970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.