Using virtual reality to treat functional dyspepsia symptoms
Effectiveness and Safety of Virtual Reality for the Treatment of Functional Dyspepsia
This study is testing if virtual reality can help people with functional dyspepsia feel better by reducing their stomach symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05836597 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of virtual reality as a treatment for gastrointestinal symptoms associated with functional dyspepsia. Participants will be assessed for their symptoms based on the Rome IV criteria and must have undergone an upper endoscopy and H. pylori testing prior to inclusion. The intervention involves utilizing virtual reality technology to potentially alleviate dyspeptic symptoms. The study aims to provide a novel approach to managing a common gastrointestinal condition.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with functional dyspepsia who meet the Rome IV criteria and have undergone necessary prior evaluations.
Not a fit: Patients with symptoms indicative of organic disorders or uncontrolled gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new, non-invasive treatment option for patients suffering from functional dyspepsia.
How similar studies have performed: While the use of virtual reality in medical treatments is emerging, this specific application for functional dyspepsia is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptoms of dyspepsia thought to represent functional dyspepsia, meeting Rome IV criteria * Had an upper endoscopy and assessment for Helicobacter pylori; if a patient is found to have H. pylori, treatment with confirmed eradication (by stool antigen test or urea breath test) will be required before the patient is eligible for study inclusion. * Patients will be considered for the study if they have undergone a complete history and physical examination during a previously scheduled consultation/evaluation visit with a gastroenterologist in the Mayo Clinic Florida General GI or Motility clinic. Exclusion Criteria: * Symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or patients have known uncontrolled GERD, esophagitis, eosinophilic esophagitis, or untreated H. pylori. * Patients with gastroparesis or cyclic vomiting syndrome. * Patients with prior surgery to the esophagus, stomach or duodenum. * Patients taking opioids. * Patients with motion sickness, vertigo, or a seizure disorder * IBS symptoms are not predominant.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: David Cangemi — Mayo Clinic
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.