Recruiting

Virtual Reality

Sponsor:

Mayo Clinic

Code:

NCT05836597

Conditions

Functional Dyspepsia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Virtual reality

Study Details

Brief summary:

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

Conditions

Functional Dyspepsia

Study ID

NCT05836597

Start date

Apr 1, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental

Experimental VR

sham comparator: Sham

Sham VR

Interventions

Virtual reality

Virtual reality

Primary outcome measure

  • Change in abdominal pain scores [ Time Frame: Baseline, 8 weeks ]

Central Contacts and Locations

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

David Cangemi, MD

904-953-2000cangemi.david@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-22.