CClinicalTrials.gg
RecruitingNCT05836597Updated Jan 22, 2026

Functional Dyspepsia Treatment Using Virtual Reality

An interventional study of Virtual reality in Functional Dyspepsia, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Functional Dyspepsia
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Experimental

    Experimental VR

    Device: Virtual reality

  • Sham comparator
    Sham

    Sham VR

    Device: Virtual reality

Interventions

  • DeviceVirtual reality

    Virtual reality

06

What researchers measure

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

  5. Change in heartburn

    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.

    Time frame: Baseline, 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05836597
Lead sponsor
Mayo Clinic
Responsible party
David J. Cangemi (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
May 1, 2023
Start date
Apr 1, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jan 22, 2026

Study contacts

David Cangemi
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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