Functional Dyspepsia Treatment Using Virtual Reality

Overview

Información sobre este estudio

The overall aim of this study is to investigate the effectiveness of virtual reality (VR) for the treatment of functional dyspepsia (FD).  We hypothesize that patients with FD who use regular sessions of VR will experience a greater improvement in dyspeptic symptoms, as measured by a reduction in symptom scores using the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM), a visual analog scale for nausea (VAS), a numerical rating scale for abdominal pain (NRS), and the Mayo Bloating Questionnaire, compared to patients with FD who use “sham” VR. 

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 Functional Dyspepsia (FD), meeting Rome IV criteria. 
  • Had an upper endoscopy and assessment for Helicobacter pylori; if a patient is found to have H. pylori, treatment with confirmed eradication (by stool antigen test or urea breath test) will be required before the patient is eligible for study inclusion.
  • 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. 
  • If a patient is interested in study participation, and if all inclusion and exclusion criteria are met, a consent form can be reviewed and signed at the time of their consultation/ evaluation clinic visit (in the presence of the PI, co-investigator, or study coordinator). 
  • Alternatively, patients can be scheduled to meet with the study coordinator to review the study and consent at a later date. 
  • The written consent form will be witnessed by the research coordinator and then scanned into the patient’s chart. 
  • 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), or if the patients have known uncontrolled GERD, esophagitis, eosinophilic esophagitis, or untreated H. pylori.  
  • Patients with gastroparesis or cyclic vomiting syndrome will be excluded. 
  • 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, as will the presence of psychiatric conditions, such as anxiety, depression, post-traumatic stress disorder, bipolar disorders, and eating disorders, such as anorexia nervosa and bulimia.  However, no patients will be excluded based on reported substance use or presence of a psychiatric comorbidity. 
  • If patients are found to have substance abuse issues or psychological issues after enrollment, they will also be referred to their primary care provider for further evaluation and treatment. 
  • Patients with motion sickness, vertigo, or a seizure disorder will be excluded to prevent the theoretical risk of inducing or exacerbating symptoms related to the aforementioned conditions with VR. 
  • Patients with co-existing IBS will be allowed to enter the study as long as IBS symptoms are not predominant.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/23/24. Questions regarding updates should be directed to the study team contact.

 

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/ /23. Questions regarding updates should be directed to the study team contact.

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 Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

David Cangemi, M.D.

Abierto para la inscripción

Contact information:

Kristen Nicole Lozano

(904) 956-9255

Lozano.Kristen@mayo.edu

More information

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