Functional Dyspepsia
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness of using virtual reality to treat gastrointestinal symptoms related to functional dyspepsia.
Interventions
DEVICEVirtual reality
Virtual reality
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in abdominal pain scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall PAGI-SYM scores | Baseline, 8 weeks | Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire. All symptoms scored 0-5, with higher scores representing more severe symptoms. A total PAGI-SYM score is determined by calculating the average of all symptom scores |
| Change in nausea/vomiting | Baseline, 8 weeks | Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire individual scores for nausea/vomiting. Scored 0-5, with higher scores representing more severe symptoms. |
| Change in bloating | Baseline, 8 weeks | Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire individual scores for bloating. Scored 0-5, with higher scores representing more severe symptoms. |
| Change in post-prandial fullness | Baseline, 8 weeks | Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire individual scores for early satiety/postprandial fullness. Scored 0-5, with higher scores representing more severe symptoms. |
| Change in heartburn | Baseline, 8 weeks | Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire individual scores for heartburn. Scored 0-5, with higher scores representing more severe symptoms. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Cangemi
Mayo Clinic
Outcome results
None listed