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WithdrawnNo phase

Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome

Key facts

Who runs it
Anthony Lembo
Where
Cleveland and Los Angeles, United StatesSee the 2 sites
Trial code
Status
Withdrawn
Started
Dec 2024
Ended
Aug 2025
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Virtual Reality Headset
Record updated
30 January 2025
Why it stopped
Collaborator is taking lead; Entry is now duplicate

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • English-speaking
  • 18 years or older
  • Meet Rome IV criteria, as diagnosed either by a licensed physician or via self-report using the Rome IBS questionnaire, for IBS for any type: IBS-C (IBS with constipation), IBS-D (IBS with diarrhea), and IBS-M (mixed-type IBS)

Who cannot take part

  • Patients using regular doses of opioid medications will also be excluded given the often-severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia
  • Individuals with a comorbid disorder that may confound the diagnosis of IBS, including:
  • celiac disease
  • inflammatory bowel disease
  • autoimmune disorders that affect the GI system
  • history of bowel resection
  • HIV/AIDS ( human immunodeficiency virus/acquired immunodeficiency syndrome)
  • diabetes with HgA1c>7.0
  • eosinophilic bowel disease
  • any other condition that a licensed physician believes can mimic IBS symptoms and undermine diagnostic certitude
  • Any history of seizure
  • Ongoing treatment for a GI cancer
  • Major audiovisual impairment (complete blindness, deafness)
  • neuroendocrine tumors
  • microscopic colitis
  • lactase deficiency
  • acute intermittent porphyria
  • No WiFi at home
  • Inability to understand English at 6th grade level
  • Any events planned over the 8 weeks of the study that could end your ability to participate in the study, such as a medical procedure, vacation, or change in residence (Note: the study team can always delay enrollment)

Where in United States

  • Cleveland Clinic - Main CampusCleveland, United StatesNo longer taking part
  • Cedars-Sinai Medical CenterLos Angeles, United StatesNo longer taking part

About the trial

What the trial wants to find out

In this study, the investigators conduct a remote, eight-week, two-arm, randomized controlled trial that assesses the benefits, primarily measured through the irritable bowel syndrome (IBS)-targeted HRQOL (health-related quality of life), of an immersive, disease-targeted virtual reality program compared to a non-immersive virtual reality program for patients with IBS.

The 2 groups in the trial

  • IBS/VR Program (SynerGI)Treatment being tested

    Treatment: Virtual Reality Headset

  • Sham VR ProgramSham treatment, for comparison

    Treatment: Virtual Reality Headset

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome: A Randomized Trial Comparing Brain-Gut Directed VR vs. Sham VR
Record updated
30 January 2025