Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome

Anthony Lembo

Status

Withdrawn

Conditions

IBS - Irritable Bowel Syndrome

Treatments

Device: Virtual Reality Headset

Study type

Interventional

Funder types

Other

Identifiers

NCT06257472

VR Study

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)