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Functional Dyspepsia Treatment Using Virtual Reality

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Mayo Clinic

Status

Enrolling

Conditions

Functional Dyspepsia

Treatments

Device: Virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT05836597
23-001973

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Experimental
Experimental group
Description:
Experimental VR
Treatment:
Device: Virtual reality
Sham
Sham Comparator group
Description:
Sham VR
Treatment:
Device: Virtual reality

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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