What is the mechanism of action of this treatment?

Common treatments for indigestion include proton pump inhibitors (PPIs), which reduce stomach acid production, and prokinetics, which enhance gastrointestinal motility. Additionally, treatments like cognitive-behavioral therapy (CBT) and virtual reality (VR) focus on distraction and relaxation to alleviate symptoms. These methods work by reducing stress and anxiety, which can exacerbate indigestion. For patients, understanding these mechanisms is crucial as they highlight the importance of both physiological and psychological factors in managing indigestion, offering a holistic approach to treatment.

What side effects are associated with this type of intervention?

Common treatments for indigestion include medications like proton pump inhibitors (PPIs) and H2 receptor antagonists, which can cause side effects such as headache, diarrhea, constipation, and abdominal pain. Non-pharmacologic treatments similar to virtual reality, such as cognitive distraction and relaxation techniques, generally have minimal side effects. These methods may occasionally cause mild discomfort or dizziness, but they are typically well-tolerated and considered safe for most patients.

What prior FDA approvals exist?

FDA-approved treatments for indigestion primarily include H2-receptor antagonists such as ranitidine, famotidine, and cimetidine, as well as proton pump inhibitors like omeprazole and esomeprazole. These medications work by reducing stomach acid production to alleviate symptoms. In addition to pharmacologic treatments, non-pharmacologic approaches such as cognitive-behavioral therapy and relaxation techniques have been explored for managing functional dyspepsia. The use of Virtual Reality (VR) for distraction and relaxation represents an innovative, non-drug approach aimed at reducing gastrointestinal symptoms through immersive experiences.

What other types of research exist?

Promising, novel alternatives to virtual reality for treating indigestion in 2024 include: 1) Psychological interventions such as cognitive behavioral therapy (CBT) and hypnotherapy, which have shown efficacy in managing gastrointestinal symptoms. 2) Dietary modifications tailored to individual intolerances, such as low FODMAP diets or gluten-free diets for those with non-celiac gluten sensitivity. 3) Complementary therapies like yoga and acupuncture, which have demonstrated benefits in reducing gastrointestinal symptoms and improving overall well-being.

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Behavioural Intervention

Virtual Reality for Indigestion

N/A

Recruiting

Led By David Cangemi

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 weeks

Awards & highlights

Summary

This trial is testing whether using virtual reality can help people with functional dyspepsia feel better. Functional dyspepsia causes stomach pain and discomfort, and typical treatments don't always work. Virtual reality might help by distracting and relaxing patients, making their symptoms less noticeable.

Who is the study for?

This trial is for individuals with functional dyspepsia, who've had an endoscopy and been checked for H. pylori infection, which must be treated if present. They should have a history of indigestion symptoms meeting Rome IV criteria but no prior stomach surgeries or conditions like IBS as the main issue.

What is being tested?

The study tests whether virtual reality can effectively treat gastrointestinal symptoms associated with functional dyspepsia. Participants will use VR technology in a controlled setting to see if it helps manage their indigestion.

What are the potential side effects?

While not typical with virtual reality, some participants may experience motion sickness or discomfort due to the immersive nature of VR. These side effects are generally mild and temporary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in abdominal pain scores

Secondary study objectives

Change in bloating

Change in heartburn

Change in nausea/vomiting

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

Experimental VR

Group II: ShamPlacebo Group1 Intervention

Sham VR

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual reality

2020

N/A

~1890

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for indigestion include proton pump inhibitors (PPIs), which reduce stomach acid production, and prokinetics, which enhance gastrointestinal motility. Additionally, treatments like cognitive-behavioral therapy (CBT) and virtual reality (VR) focus on distraction and relaxation to alleviate symptoms. These methods work by reducing stress and anxiety, which can exacerbate indigestion. For patients, understanding these mechanisms is crucial as they highlight the importance of both physiological and psychological factors in managing indigestion, offering a holistic approach to treatment.

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Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,298 Previous Clinical Trials

3,958,415 Total Patients Enrolled

David CangemiPrincipal InvestigatorMayo Clinic

Media Library

Virtual reality (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05836597 — N/A

Indigestion Research Study Groups: Experimental, Sham

Indigestion Clinical Trial 2023: Virtual reality Highlights & Side Effects. Trial Name: NCT05836597 — N/A

Virtual reality (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05836597 — N/A

~17 spots leftby Jun 2025

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