Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome

NCT06257472 | Withdrawn

• 1 other identifier: VR Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

IBS - Irritable Bowel Syndrome

Keywords

Virtual Reality; IBS

Outcome Measures

Primary Outcomes (1)

• IBS-targeted HRQOL (health-related quality of life)

  The primary outcome will be an increase in IBS-QOL (quality of life) scores between baseline and week 8 for those on the study arm. Each question is positively scored 1-5, and the sum is normalized into a 0-100 score, with 100 being the highest reported quality of life and 0 being the lowest.

  Baseline, after 4 weeks using device, after 8 weeks using device

Secondary Outcomes (9)

• GI (Gastrointestinal) Pain Intensity

  Baseline, after 4 weeks using device, after 8 weeks using device

• IBS symptom severity

  Weekly for 8 weeks

• Visceral anxiety

  Baseline, after 4 weeks using device, after 8 weeks using device

• Generalized anxiety

  Baseline, after 4 weeks using device, after 8 weeks using device

• Maladaptive GI (Gastrointestinal) cognitions

  Baseline, after 4 weeks using device, after 8 weeks using device

Study Arms (2)

IBS/VR Program (SynerGI)

EXPERIMENTAL

Device: Virtual Reality Headset

Sham VR Program

SHAM COMPARATOR

Device: Virtual Reality Headset

Interventions

Virtual Reality Headset 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.

IBS/VR Program (SynerGI); Sham VR Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Anthony Lembo: lead
• Cedars-Sinai Medical Center: collaborator

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Anthony Lembo, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chair of Research

Model Details: Two-armed blinded clinical trial

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 14, 2024
• Study Start: December 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)