Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05836597

Functional Dyspepsia Treatment Using Virtual Reality

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

David Cangemi, MD

CONTACT

[email protected]

904-953-2000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality

Device

Virtual reality

Primary outcomes

  1. Change in abdominal pain scores

    Time frame: 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 outcomes

  1. Overall PAGI-SYM scores

    Time frame: 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

  2. Change in nausea/vomiting

    Time frame: 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.

  3. Change in bloating

    Time frame: 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.

  4. Change in post-prandial fullness

    Time frame: 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.

  5. Change in heartburn

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Effectiveness and Safety of Virtual Reality for the Treatment of Functional Dyspepsia

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 1, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.