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Behavioural Intervention

Virtual Reality for Irritable Bowel Syndrome

N/A
Recruiting
Led By Anthony Lembo, MD
Research Sponsored by Anthony Lembo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet Rome IV criteria for IBS for any type: IBS-C, IBS-D, and IBS-M
18 years or older
Must not have
Patients using regular doses of opioid medications
Ongoing treatment for a GI cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after 4 weeks using device, after 8 weeks using device

Summary

"This trial will test if a special virtual reality program can help improve the quality of life for patients with irritable bowel syndrome (IBS) compared to a regular virtual reality program. It will last for

Who is the study for?
This trial is for individuals with Irritable Bowel Syndrome (IBS). Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis of IBS and may be required to meet certain health conditions.
What is being tested?
The study is testing the effectiveness of an immersive virtual reality program designed for IBS patients. It compares this program to a non-immersive VR experience over eight weeks, measuring improvements in health-related quality of life.
What are the potential side effects?
While specific side effects are not listed, VR experiences can sometimes cause motion sickness or eye strain. Participants should report any discomfort they experience during the use of the VR headset.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with IBS according to Rome IV criteria.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I regularly take opioid medications.
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I am currently receiving treatment for gastrointestinal cancer.
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I have significant hearing or vision loss.
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I have had seizures in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at screening/baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening/baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
IBS-targeted HRQOL (health-related quality of life)
Secondary study objectives
GI (Gastrointestinal) Pain Intensity
Generalized anxiety
IBS symptom severity
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IBS/VR Program (SynerGI)Experimental Treatment1 Intervention
Group II: Sham VR ProgramPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual Reality Headset
2022
N/A
~500

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterOTHER
512 Previous Clinical Trials
163,289 Total Patients Enrolled
8 Trials studying Irritable Bowel Syndrome
301 Patients Enrolled for Irritable Bowel Syndrome
Anthony LemboLead Sponsor
1 Previous Clinical Trials
340 Total Patients Enrolled
1 Trials studying Irritable Bowel Syndrome
340 Patients Enrolled for Irritable Bowel Syndrome
Anthony Lembo, MDPrincipal InvestigatorThe Cleveland Clinic
5 Previous Clinical Trials
1,256 Total Patients Enrolled
4 Trials studying Irritable Bowel Syndrome
1,239 Patients Enrolled for Irritable Bowel Syndrome
~50 spots leftby Aug 2025
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