Virtual reality therapy for treating irritable bowel syndrome
Randomized Controlled Trial of Virtual Reality Therapies for Irritable Bowel Syndrome
NA · Cedars-Sinai Medical Center · NCT06687616
This study is testing if a virtual reality therapy program can help people with irritable bowel syndrome feel less abdominal pain and improve their daily life compared to a fake VR experience.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center (other) |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06687616 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to evaluate the clinical impact and feasibility of a virtual reality cognitive behavioral therapy (VR CBT) program compared to sham VR in patients with irritable bowel syndrome (IBS). Participants will be randomly assigned to either the immersive VR CBT program or a sham VR experience, with assessments conducted at baseline, 4 weeks, and 8 weeks. The study will focus on collecting preliminary data on the effectiveness of the VR CBT in reducing abdominal pain and improving overall functioning. The trial will follow established NIH protocols for VR clinical trials and will include a total of 60 participants, balanced by sex.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with Rome IV IBS who experience clinically significant abdominal pain and can engage with the VR technology.
Not a fit: Patients with conditions that interfere with VR usage or those with cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce abdominal pain and improve the quality of life for patients with IBS.
How similar studies have performed: While this approach is innovative, similar studies using VR for other conditions have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Has been diagnosed by a physician with Rome IV IBS; all subtypes will be included * Has clinically significant abdominal pain as defined as an NIH PROMIS abdominal pain T-score ≥ 55 (0.5 standard deviation \[SD\] above the normalized population mean of 50) * Able to read/write English (SynerGI is currently only available in English) * Owns a compatible android or iOS smartphone, or personal laptop or desktop computer (excluding tablets) to complete surveys and has access to internet and email Exclusion Criteria: * Presents with a condition that interferes with VR usage, including history of seizure, facial injury precluding safe placement of headset, significant visual or hearing impairment that impacts ability to see the VR images or follow audio instructions * Has cognitive impairment that would affect protocol participation * Has 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, diabetes with HgA1c \>=7.0, neuroendocrine tumors, microscopic colitis, eosinophilic bowel disease, acute intermittent porphyria, or any other condition that a physician believes can mimic IBS symptoms and undermine diagnostic certitude * Takes standing doses of opioid medications given the often severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia * Previously participated in a VR clinical trial * Previously participated in talk therapy * Previously used a VR program to treat their IBS
Where this trial is running
Los Angeles, California and 1 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Christopher V Almario, MD, MSHPM — Cedars-Sinai Medical Center
- Study coordinator: Zoe G Krut, MSHS
- Email: Zoe.Krut@cshs.org
- Phone: 310-423-0699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: IBS - Irritable Bowel Syndrome, Virtual Reality, Cognitive Behavioral Therapy