Virtual Reality for Indigestion

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Opioids

Disqualifiers: Peptic ulcer, Hepatitis, Pancreatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual reality can help with indigestion, specifically for those diagnosed with functional dyspepsia (a type of chronic indigestion). Participants will either undergo real virtual reality sessions designed to relieve symptoms or a sham version without therapeutic effects. The trial seeks individuals who have had a thorough check-up, including a test for the stomach bacteria Helicobacter pylori, and have been cleared by a gastroenterologist. Those dealing with unexplained indigestion who have already ruled out other major stomach issues might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for indigestion.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking opioids, you would not be eligible to participate.

What prior data suggests that virtual reality is safe for treating indigestion?

Research has shown that virtual reality (VR) is safe for treating functional dyspepsia, a type of indigestion. Studies have demonstrated that VR helps improve symptoms in people with this condition, with no major safety issues identified. While further research with larger groups is recommended, current evidence indicates that patients tolerate VR well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for indigestion because it offers a completely new approach compared to traditional treatments like antacids, proton pump inhibitors, and dietary changes. Unlike these standard treatments, which focus on chemically altering stomach acid or managing diet, VR uses immersive technology to potentially reduce stress and anxiety, which can be significant contributors to indigestion symptoms. This method could provide a non-invasive, drug-free option that engages the mind to help soothe the digestive system, offering a novel and exciting avenue for relief.

What evidence suggests that virtual reality is effective for indigestion?

Research has shown that virtual reality (VR), which participants in this trial may receive, can help improve symptoms of functional dyspepsia, a type of indigestion. One study found that VR significantly relieved symptoms like discomfort and pain in people with this condition. This trial will compare the effects of experimental VR with a sham VR treatment. Several studies have also shown that VR may help treat other digestive issues, such as irritable bowel syndrome (IBS). Overall, VR has proven to be a safe option with promising results. ^{1 2 3 4 5}

Who Is on the Research Team?

David Cangemi

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I've been tested and treated for H. pylori if needed, confirmed by further testing.

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

I have been diagnosed with functional dyspepsia.

Exclusion Criteria

I have symptoms of a physical illness like an ulcer, hepatitis, or untreated infection.

Patients with motion sickness, vertigo, or a seizure disorder

I have gastroparesis or cyclic vomiting syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either experimental or sham virtual reality treatment for functional dyspepsia

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual reality
• Virtual Reality

Trial Overview 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.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Experimental VR

Group II: Sham Placebo Group 1 Intervention

Sham VR

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A new MRI protocol using a water challenge was successfully implemented to assess gastric function in patients with Ehlers-Danlos Syndrome-Hypermobility type (EDS-HT), showing it can be done in under 60 minutes.

The study found that EDS-HT patients had significantly lower gastric motility after the water challenge compared to matched controls, suggesting potential differences in gastric function that warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A magnetic resonance imaging study of gastric motor function in patients with dyspepsia associated with Ehlers-Danlos Syndrome-Hypermobility Type: A feasibility study. Menys, A., Keszthelyi, D., Fitzke, H., et al.[2018]

Disorders of gut-brain interaction (DGBIs), such as functional dyspepsia and irritable bowel syndrome (IBS), are common and significantly impact patients' quality of life, highlighting the need for effective treatments.

Recent studies suggest that virtual reality (VR) technology may be a promising novel therapy for alleviating chronic abdominal pain associated with DGBIs, potentially offering a non-invasive alternative to traditional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? Lacy, BE., Cangemi, DJ., Spiegel, BR.[2023]

The IBS/VR program, designed to help patients with irritable bowel syndrome (IBS) through immersive virtual reality experiences, effectively teaches techniques related to the brain-gut axis and cognitive behavioral therapy.

Patient feedback led to 23 software changes, confirming the program's adaptability and relevance, with thematic saturation achieved after 15 interviews, indicating strong acceptance and potential efficacy of this innovative treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Validation of a Novel VR Program for Irritable Bowel Syndrome: A VR1 Study. Spiegel, BMR., Liran, O., Gale, R., et al.[2022]

Active virtual reality (VR) therapy significantly improved symptoms of functional dyspepsia compared to sham VR, with a notable mean difference in symptom severity scores over a 2-week period.

The study found that VR was safe, with only one patient withdrawing due to nonserious adverse effects, suggesting it could be a beneficial treatment option for managing dyspepsia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. Cangemi, DJ., Montenegro, M., Spiegel, BMR., et al.[2023]

The modified Reflux Symptom Questionnaire-electronic Diary (mRESQ-eD) was validated through patient feedback and psychometric testing, demonstrating high internal consistency (Coefficient ω = 0.95) and strong reliability for assessing symptoms in patients with persistent gastroesophageal reflux disease (GERD).

The final 8-item version of the mRESQ-eD is a reliable and valid tool that can be used in clinical trials to evaluate treatment benefits for GERD, aligning with FDA guidelines for patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation and Validation of the Modified Reflux Symptom Questionnaire-Electronic Diary in Patients With Persistent Gastroesophageal Reflux Disease. Andrae, DA., Hanlon, J., Cala, ML., et al.[2022]

The review analyzed 36 studies on dyspepsia treatment, highlighting that many had strict eligibility criteria which limited the applicability of their findings to broader populations suffering from dyspeptic symptoms.

It was found that the use of validated Patient Reported Outcome Measurements (PROMs) is crucial for future research, suggesting that developing standardized PROMs could enhance the effectiveness of treatments for upper gastrointestinal disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design characteristics of comparative effectiveness trials for the relief of symptomatic dyspepsia: A systematic review. Elliott, N., Steel, A., Leech, B., et al.[2022]

A systematic review of randomized controlled trials (RCTs) on esophageal motility disorders (EMDs) found that the overall completeness of reporting patient-reported outcomes (PROs) was only 43.86%, indicating a significant gap in capturing patient perspectives.

RCTs that included a primary PRO measure had better reporting completeness (47.73%) compared to those with secondary PROs (35.36%), highlighting the importance of prioritizing PROs in EMD research to enhance patient-centered outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Reporting Completeness of Patient-Reported Outcomes in Esophageal Motility Disorders: A Cross-Sectional Analysis of Randomized Controlled Trials. Staggs, J., Williams, C., Love, M., et al.[2022]

Citations

1. mayoclinic.org mayoclinic.org/medical-professionals/digestive-diseases/news/assessing-the-effectiveness-and-safety-of-virtual-reality-in-treating-functional-dyspepsia/mac-20574578

Assessing the effectiveness and safety of virtual reality in ... Virtual reality improves symptoms of functional dyspepsia: Results of a randomized, double-blind, sham-controlled, pilot study. The American ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9972609/

Virtual Reality: A New Treatment Paradigm for Disorders of ... Two recent novel studies have demonstrated that VR has the potential to play an important role in the treatment of functional dyspepsia and IBS. This article ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37655713/

Virtual Reality Improves Symptoms of Functional Dyspepsia VR is safe and results in significant symptom improvement in functional dyspepsia. Larger trials are warranted.

4. journals.lww.com journals.lww.com/ajg/fulltext/2021/10001/s515_virtual_reality_improves_symptoms_of.516.aspx

S515 Virtual Reality Improves Symptoms of Functional... In this preliminary analysis, VR was shown to be safe and result in statistically significant overall improvement in symptoms in FD patients, most pronounced in ...

5. withpower.com withpower.com/trial/phase-dyspepsia-6-2023-ed76e

Virtual Reality for Indigestion Research shows that virtual reality (VR) can help improve symptoms of functional dyspepsia, a common type of indigestion, by providing pain relief. VR has also ...