NCT05836597RecruitingNot Applicable
Effectiveness and Safety of Virtual Reality for the Treatment of Functional Dyspepsia
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in abdominal pain scores
Study Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness of using virtual reality to treat gastrointestinal symptoms related to functional dyspepsia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Experimental
Experimental
Experimental VR
Intervention: Virtual reality (Device)
Sham
Sham Comparator
Sham VR
Intervention: Virtual reality (Device)
Outcomes
Primary Outcomes
Change in abdominal pain scores
Time Frame: Baseline, 8 weeks
Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire individual scores for abdominal pain. Scored 0-5, with higher scores representing more severe symptoms.
Secondary Outcomes
- Change in nausea/vomiting(Baseline, 8 weeks)
- Change in bloating(Baseline, 8 weeks)
- Change in post-prandial fullness(Baseline, 8 weeks)
- Overall PAGI-SYM scores(Baseline, 8 weeks)
- Change in heartburn(Baseline, 8 weeks)
Investigators
David J. Cangemi
Principal Investigator
Mayo Clinic
Study Sites (1)
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