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- Withdrawn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