A Study to Evaluate the Effectiveness and Safety of Virtual Reality in the Treatment of Functional Dyspepsia

Overview

Información sobre este estudio

The purpose of this study is to investigate the effectiveness of virtual reality (VR) for the treatment of functional dyspepsia (FD). 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Jacksonville, Fla.

Investigador principal de Mayo Clinic

David Cangemi, M.D.

Cerrado para la inscripción

More information

Publicaciones

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CLS-20502625

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