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.
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications, but you cannot participate if you are taking opioids.
What data supports the idea that Virtual Reality for Indigestion is an effective treatment?The available research shows that virtual reality (VR) can be an effective treatment for indigestion, specifically functional dyspepsia. One study found that VR improved symptoms in patients with this condition. Additionally, VR has been shown to help with other gut-related issues like irritable bowel syndrome (IBS), which shares some symptoms with indigestion. This suggests that VR could be a promising option for managing indigestion symptoms.69101112
What safety data exists for Virtual Reality therapy for indigestion?The provided research does not contain any safety data specifically related to Virtual Reality therapy for indigestion or any of its alternative names. The studies focus on other treatments and conditions, such as fiber supplements, famotidine, and functional gastrointestinal disorders, but do not address Virtual Reality therapy.12348
Is virtual reality a promising treatment for indigestion?Yes, virtual reality is a promising treatment for indigestion. It has been shown to improve symptoms of functional dyspepsia, a common type of indigestion, by providing a multisensory experience that can relieve pain and other symptoms.5791112
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.Treatment Details
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Experimental VR
Group II: ShamPlacebo Group1 Intervention
Sham VR
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mayo Clinic in FloridaJacksonville, FL
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
References
Famotidine: postmarketing clinical experience. [2019]A postmarketing survey of famotidine usage (phase IV survey) tracked 6346 patients at 602 locations from August 1985 to April 1986. Through the survey, the efficacy and the safety of famotidine were studied. The patients included 4618 cases of peptic ulcer, 106 cases of reflux esophagitis, 1006 cases of upper gastrointestinal tract bleeding, 343 cases of bleeding and ulcer prophylaxis, and 273 cases of gastritis and other diseases, totalling 6346 patients. Efficacy was analyzed by type of disease in terms of overall improvement; results of intermittent hemostatic efficacy were obtained for upper gastrointestinal tract bleeding; and safety was assessed. Overall, the results were good; the 8-week healing rate was 92.4%, and 72.3% of patients had their bleeding controlled within 7 days of beginning famotidine therapy. Side effects occurred in only 0.43% of patients, and abnormalities in laboratory test results were observed in less than 1% of patients. Gastrointestinal side effects, especially constipation, occurred most frequently. Most side effects were mild. The results of this postmarketing survey indicate that famotidine is a safe and effective H2-receptor antagonist.
Systematic review of randomized controlled trials: fiber supplements for abdominal pain-related functional gastrointestinal disorders in childhood. [2022]A lack of safe and reliable treatments for abdominal pain-related functional gastrointestinal disorders (FGIDs) has prompted interest in new therapies.
Design of Treatment Trials for Functional Gastrointestinal Disorders. [2022]This article summarizes recent progress and regulatory guidance on design of trials to assess the efficacy of new therapies for functional gastrointestinal disorders (FGIDs). The double-masked, placebo-controlled, parallel-group design remains the accepted standard for evaluating treatment efficacy. A control group is essential, and a detailed description of the randomization process and concealed allocation method must be included in the study report. The control will most often be placebo, but for therapeutic procedures and for behavioral treatment trials, respectively, a sham procedure and control intervention with similar expectation of benefit, but lacking the treatment principle, are recommended. Investigators should be aware of, and attempt to minimize, expectancy effects (placebo, nocebo, precebo). The primary analysis should be based on the proportion of patients in each treatment arm who satisfy a treatment responder definition or a prespecified clinically meaningful change in a patient-reported outcome measure. Data analysis should use the intention-to-treat principle. Reporting of results should follow the Consolidated Standards for Reporting Trials guidelines and include secondary outcome measures to support or explain the primary outcome and an analysis of harms data. Trials should be registered in a public location before initiation and results should be published regardless of outcome.
White Paper AGA: Functional Dyspepsia. [2018]Functional dyspepsia remains a major challenge for clinicians with no approved drugs available in the Western World. In October 2016, a meeting was held in Washington, DC, sponsored by the American Gastroenterological Association's Center for Diagnostics and Therapeutics, which included members of the Food and Drug Administration (FDA) and the pharmaceutical industry, experts in FD, and representatives of patient organizations. This white paper summarizes our current status, progress with a validated patient reported outcome instrument in functional dyspepsia, future directions and needs.
A magnetic resonance imaging study of gastric motor function in patients with dyspepsia associated with Ehlers-Danlos Syndrome-Hypermobility Type: A feasibility study. [2018]The clinical use of Magnetic Resonance Imaging (MRI) for investigating gastric motor function in dyspepsia is limited, largely due to protocol complexity, cost and limited availability. In this study, we explore the feasibility of a sub 60-minute protocol using a water challenge to assess gastric emptying, motility and accommodation in a cohort of Ehlers-Danlos Syndrome-Hypermobility type (EDS-HT) patients presenting with dyspepsia.
Evaluation and Validation of the Modified Reflux Symptom Questionnaire-Electronic Diary in Patients With Persistent Gastroesophageal Reflux Disease. [2022]This study aimed to examine the validity of the modified Reflux Symptom Questionnaire-electronic Diary (mRESQ-eD) through patient input and psychometric testing of the questionnaire to support use in clinical trials in patients with persistent gastroesophageal reflux disease (GERD) and in accordance with Food and Drug Administration guidance on patient-reported outcome instruments.
Design characteristics of comparative effectiveness trials for the relief of symptomatic dyspepsia: A systematic review. [2022]Dyspepsia represents a symptom domain rather than a diagnostic condition and covers a wide range of complex, underlying pathophysiologies that are not well understood. The review explores comparative effectiveness interventions for the treatment of symptomatic dyspepsia along a pragmatic-explanatory continuum. The aim is to identify relevant design characteristics applicable to future upper gastrointestinal comparative effectiveness research employing integrative medicine.
Development and Validity Assessment of a Self-evaluation Questionnaire for Functional Dyspepsia: A Multicenter Prospective Study in Korea. [2022]Patient-reported outcomes (PROs) are essential for clinical decision making, conduction of clinical research, and drug application acquisition in functional gastrointestinal disorders. The aim of this study is to develop a PRO instrument and to determine the respondents' perception of the efficacy of therapeutic agents for functional dyspepsia (FD).
Qualitative Validation of a Novel VR Program for Irritable Bowel Syndrome: A VR1 Study. [2022]Although gut-directed psychotherapies are effective for irritable bowel syndrome (IBS), they are rarely prescribed, given a paucity of trained clinicians. Virtual reality (VR) offers a solution by allowing patients to self-practice these techniques in a standardized manner.
Evaluating Reporting Completeness of Patient-Reported Outcomes in Esophageal Motility Disorders: A Cross-Sectional Analysis of Randomized Controlled Trials. [2022]Esophageal motility disorders (EMD) can have significant effects on quality of life. Patient-reported outcomes (PROs) provide valuable insight into the patient's perspective on their treatment and are becoming increasingly used in randomized controlled trials (RCTs). Thus, our investigation aims to evaluate the completeness of reporting of PROs in RCTs pertaining to EMDs. We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for published RCTs focused on EMDs. Included RCTs were published between 2006 and 2020, reported a primary outcome related to an EMDs, and listed at least one PRO measure as a primary or secondary outcome. Investigators screened and extracted data in a masked, duplicate fashion. Data extraction was carried out using both the CONSORT-PRO adaptation and Cochrane Collaboration Risk of Bias 2.0 tool. We assessed overall mean percent completion of the CONSORT-PRO adaptation and a bivariate regression analysis was used to assess relationships between trial characteristics and completeness of reporting. The overall mean percent completion of the CONSORT-PRO checklist adaptation was 43.86% (SD = 17.03). RCTs with a primary PRO had a mean completeness of 47.73% (SD = 17.32) and RCTs with a secondary PRO was 35.36% (SD = 13.52). RCTs with a conflict of interest statement were 18.15% (SE = 6.5) more complete (t = 2.79, P = .009) than trials lacking a statement. No additional significant associations between trial characteristics and completeness of reporting were found. PRO reporting completeness in RCTs focused on EMDs was inadequate. We urge EMD researchers to prioritize complete PRO reporting to foster patient-centered research for future RCTs on EMDs.
Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? [2023]Disorders of gut-brain interaction (DGBIs), previously called functional bowel disorders, are prevalent, reduce patients' quality of life, and impose a significant negative economic impact on the health care system. Functional dyspepsia and irritable bowel syndrome (IBS) are 2 of the most common DGBIs. An overlying, and in many cases unifying, symptom for many of these disorders is the presence of abdominal pain. Chronic abdominal pain can be difficult to treat, as many antinociceptive agents are associated with side effects that limit their use and other agents may only partially improve, but not completely relieve, all aspects of the pain. Novel therapies to alleviate chronic pain and the other symptoms that characterize DGBIs are thus needed. Virtual reality (VR), a technology that immerses patients in a multisensory experience, has been shown to relieve pain in burn victims and other instances of somatic pain. 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 examines the development of VR, its role in the treatment of somatic and visceral pain, and its potential position in the treatment of DGBIs.
Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. [2023]We investigated the efficacy and safety of virtual reality (VR) for functional dyspepsia.