A Study to Evaluate the Effectiveness and Safety of Virtual Reality in the Treatment of Functional Dyspepsia
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-011789
Sponsor Protocol Number: 18-011789
About this study
The purpose of this study is to investigate the effectiveness of virtual reality (VR) for the treatment of functional dyspepsia (FD).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult patients, men and women ages 18-75.
- Symptoms of dyspepsia thought to represent FD.
- Meeting Rome IV criteria.
- Patients will be identified as direct referrals to the general GI clinic or the motility clinic.
Referring providers will be notified of active research in the Division of Gastroenterology, and this study will be highlighted.
- Symptoms will be assessed and patients will be categorized into either the postprandial distress syndrome (PDS), epigastric pain syndrome (EPS), or mixed subtype, using Rome IV criteria.
Exclusion Criteria:
- Patients will be excluded from the study if symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease).
- Patients have known uncontrolled GERD, esophagitis, eosinophilic esophagitis or H. pylori.
- Patients with prior surgery to the esophagus, stomach or duodenum will be excluded.
- Patients taking opioids will also be excluded.
- Alcohol and tobacco use will be assessed.
- Presence of psychiatric conditions, such as anxiety, depression, post-traumatic stress disorder, bipolar disorders, and eating disorders, such as anorexia nervosa and bulimia.
- No patients will be excluded based on reported substance use or presence of a psychiatric comorbidity.
- Patients with co-existing IBS will be allowed to enter the study as long as IBS symptoms are not predominant.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator David Cangemi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available