NCT06257472

Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome

Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome: A Randomized Trial Comparing Brain-Gut Directed VR vs. Sham VR

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Anthony Lembo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-02-14
• Last updated: 2025-01-30

Locations

2 sites across 1 country: United States