Health TrialsbyHealthPanel

Functional Dyspepsia Treatment Using Virtual Reality

ConditionFunctional Dyspepsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMayo Clinic

About this trial

The purpose of this study is to evaluate the effectiveness of using virtual reality to treat gastrointestinal symptoms related to functional dyspepsia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual reality

    Device

    Virtual reality

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in abdominal pain scores

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.

Time frame
Baseline, 8 weeks

Secondary outcomes

1

Overall PAGI-SYM scores

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

Time frame
Baseline, 8 weeks
2

Change in nausea/vomiting

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.

Time frame
Baseline, 8 weeks
3

Change in bloating

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.

Time frame
Baseline, 8 weeks
4

Change in post-prandial fullness

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.

Time frame
Baseline, 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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