Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome

NCT ID: NCT06257472

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-08-31

Brief Summary

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.

Detailed Description

In this study, the investigators will conduct a decentralized, remote, eight-week, two-arm, randomized controlled trial of SynerGI, a disease-targeted, brain-gut directed, immersive VR program for people with IBS, versus sham VR delivered in a VR headset. Eligible participants will be assigned to a study arm using a 1:1 random number generator and will be blinded to allocation. Data analysts will also be blinded to allocation; only pre-specified staff who are uninvolved with data analyses will be unblinded for purposes of study administration (e.g., sending allocation-specific study materials). After completion of the treatment, participants will be invited to participate in an optional 30-minute semi-structured interview to better understand their experiences of VR treatment. Qualitative interviews will be audio-recorded and transcribed.

The primary aim of this study will be to assess the benefits of disease-targeted VR compared to sham VR on clinically relevant outcomes. The second aim will seek to determine patient-level predictors of treatment response to active VR therapy. The third aim will seek to understand patient experiences of VR to better inform the design of VR treatments for digestive diseases in the future.

Conditions

IBS - Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

IBS/VR Program (SynerGI)

Group Type: EXPERIMENTAL

Virtual Reality Headset

Intervention Type: DEVICE

Participants will be mailed a Meta Quest 2 Headset. Participants will be asked to wear and use the VR headset for around 20 minutes each day for 8 weeks.

Sham VR Program

Group Type: SHAM_COMPARATOR

Virtual Reality Headset

Intervention Type: DEVICE

Participants will be mailed a Meta Quest 2 Headset. Participants will be asked to wear and use the VR headset for around 20 minutes each day for 8 weeks.

Interventions

Virtual Reality Headset

Participants will be mailed a Meta Quest 2 Headset. Participants will be asked to wear and use the VR headset for around 20 minutes each day for 8 weeks.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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
• neuroendocrine tumors
• microscopic colitis
• lactase deficiency
• eosinophilic bowel disease
• acute intermittent porphyria
• any other condition that a licensed physician believes can mimic IBS symptoms and undermine diagnostic certitude
• 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
• No WiFi at home
• Any history of seizure
• Ongoing treatment for a GI cancer
• Major audiovisual impairment (complete blindness, deafness)
• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: collaborator

Anthony Lembo

OTHER

Sponsor Role: lead

Responsible Party

Anthony Lembo

Vice Chair of Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anthony Lembo, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

VR Study

Identifier Type: -

Identifier Source: org_study_id