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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment 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 been effective in treating other gut-related issues like irritable bowel syndrome (IBS), suggesting it could be a promising treatment for indigestion. ^{1 2 3 4 5}

How is virtual reality treatment different from other treatments for indigestion?

Virtual reality treatment for indigestion is unique because it immerses patients in a multisensory experience, which can help relieve pain and other symptoms without the side effects often associated with traditional medications. This approach allows patients to self-practice techniques that are usually part of gut-directed psychotherapies, offering a novel way to manage symptoms. ^{1 2 3 6 7}

Research Team

David Cangemi

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

I have gastroparesis or cyclic vomiting syndrome.

I am currently taking opioids for pain.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Qualitative Validation of a Novel VR Program for Irritable Bowel Syndrome: A VR1 Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation and Validation of the Modified Reflux Symptom Questionnaire-Electronic Diary in Patients With Persistent Gastroesophageal Reflux Disease. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluating Reporting Completeness of Patient-Reported Outcomes in Esophageal Motility Disorders: A Cross-Sectional Analysis of Randomized Controlled Trials. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Design characteristics of comparative effectiveness trials for the relief of symptomatic dyspepsia: A systematic review. [2022]

7. England 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. [2018]