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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
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
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 moreTrial 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
~1850
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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Rumination, heartburn, and daytime gastroesophageal reflux. A case study with mechanisms defined and successfully treated with biofeedback therapy.Patient response to marketing minimally invasive surgery for heartburn.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,342 Previous Clinical Trials
3,062,302 Total Patients Enrolled
David CangemiPrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have symptoms of a physical illness like an ulcer, hepatitis, or untreated infection.I've been tested and treated for H. pylori if needed, confirmed by further testing.I have gastroparesis or cyclic vomiting syndrome.I am currently taking opioids for pain.My main health issue is not IBS symptoms.I have had surgery on my esophagus, stomach, or duodenum.I have been diagnosed with functional dyspepsia.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
- Group 2: Sham
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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