Functional Dyspepsia Treatment Using Virtual Reality

Not Applicable

Recruiting

• Conditions: Functional Dyspepsia
• Interventions: Device: Virtual reality

• Registration Number: NCT05836597
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-01
• Status Verified: 2024-04
• Study Start: 2024-04-01
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Virtual reality	Experimental VR
Sham	Virtual reality	Sham VR

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States