VR Therapy for Irritable Bowel Syndrome

Not currently recruiting at 1 trial location

Overseen By Samuel Eberlein, MSHS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Christopher Almario

Must not be taking: Opioids

Disqualifiers: Seizure history, Cognitive impairment, Celiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual reality (VR) cognitive behavioral therapy (CBT) program to determine its effectiveness in reducing abdominal pain and improving daily life for individuals with irritable bowel syndrome (IBS). Participants will use either the new VR program, SynerGI, or a simpler VR experience featuring nature videos. The trial targets individuals diagnosed with IBS who experience significant abdominal pain and have access to a smartphone or computer. As an unphased trial, it offers a unique opportunity to explore innovative therapies that could enhance the quality of life for IBS sufferers.

Will I have to stop taking my current medications?

The trial requires that participants do not take standing doses of opioid medications, as these can affect the gut. If you are on opioids, you may need to stop them to participate.

What prior data suggests that this VR therapy is safe for IBS patients?

Research has shown that virtual reality (VR) therapy is generally safe and easy to handle. Although specific safety information for using VR to treat irritable bowel syndrome (IBS) is lacking, VR treatments are usually considered low-risk. Studies on other conditions have found VR to be safe. For SynerGI, the VR program under testing, similar VR treatments have reported no serious side effects. Most people find VR simple to use and experience no major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for irritable bowel syndrome (IBS), which often include medications like antispasmodics, fiber supplements, or dietary changes, SynerGI is unique because it employs virtual reality (VR) technology to deliver cognitive-behavioral therapy (CBT). This innovative approach allows patients to experience a series of interactive virtual environments through the Meta Quest 2 headset, helping them develop coping skills at home over an 8-week period. Researchers are excited about SynerGI because it combines the therapeutic benefits of CBT with the immersive power of VR, potentially offering a non-drug alternative that empowers patients to manage their symptoms more effectively in their daily lives.

What evidence suggests that this VR therapy is effective for irritable bowel syndrome?

This trial will compare two VR therapy approaches for irritable bowel syndrome (IBS). Participants in the SynerGI arm will use a standardized CBT program delivered through a VR device, which has shown promise in reducing stomach pain and improving overall well-being. Meanwhile, the Sham VR arm will offer a distraction-based VR therapy program with 2D nature videos. Studies have shown that VR therapy can help people with IBS by providing a virtual space to learn and practice skills for better condition management. Initial findings suggest that VR therapy addresses not only physical symptoms but also supports mental and social health. ^{1 2 6 7 8}

Who Is on the Research Team?

Christopher V Almario, MD, MSHPM

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with significant abdominal pain from IBS, who can read/write English, own a compatible smartphone or computer with internet access. Excluded are those with conditions affecting VR use (like seizures), other GI disorders that could be confused with IBS, opioid medication users, previous VR/CBT trial participants, and those with cognitive impairments.

Inclusion Criteria

Able to read/write English (SynerGI is currently only available in English)

Owns a compatible android or iOS smartphone, or personal laptop or desktop computer (excluding tablets) to complete surveys and has access to internet and email

I experience significant abdominal pain.

Exclusion Criteria

Presents with a condition that interferes with VR usage, including history of seizure, facial injury precluding safe placement of headset, significant visual or hearing impairment that impacts ability to see the VR images or follow audio instructions

I take regular opioid medication.

Previously participated in a VR clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week VR cognitive behavioral therapy (CBT) program or sham VR therapy

8 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham VR
• SynerGI

Trial Overview The study tests if VR-based cognitive behavioral therapy can reduce abdominal pain in IBS patients compared to sham VR. Participants will randomly receive either the actual VR CBT program or a placebo-like version without therapeutic content.

How Is the Trial Designed?

Group I: SynerGI Experimental Treatment 1 Intervention

The standardized CBT program (SynerGI) will be delivered through the Meta Quest 2 device and is self-administered and includes a network of environments arranged in a virtual clinic that participants experience at home though a protocolized, 8-week program. Depending on the module, experiences within the program last between 5-20 minutes. Participants will be prompted to regularly use the headset each week over the 8-week study period. The VR modules are reinforced with regularly scheduled messages and CBT exercises delivered by a webapp that is available on any smartphone or computer. The program progressively builds new skills and culminates in transitioning from using VR to applying the skills learned in VR to everyday life.

Group II: Sham VR Placebo Group 1 Intervention

Patients in the sham VR group will receive the same Meta Quest 2 device but will only have access to a distraction-based VR therapy program that includes 2D nature videos (e.g., relaxing on a beach, swimming with dolphins). Similar to the SynerGI arm, people in the sham VR group will be prompted to regularly use the headset each week for the 8-week treatment period.

Who Is Running the Clinical Trial?

Christopher Almario

Lead Sponsor

Trials

1

Recruited

70+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A rapid review of seven studies found that Virtual Reality (VR) interventions during colonoscopy significantly reduced patients' pain and anxiety while increasing their satisfaction with the procedure.

VR interventions are a feasible and effective alternative for patients who wish to avoid pain medications or as a complement to standard sedation during colonoscopy, suggesting a promising approach to improve patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions to reduce psychological distress during colonoscopy: a rapid review. Shamali, M., Vilmann, P., Johansen, NR., et al.[2023]

The IBS/VR program, designed to help patients with irritable bowel syndrome (IBS) through immersive virtual reality experiences, effectively teaches techniques related to the brain-gut axis and cognitive behavioral therapy.

Patient feedback led to 23 software changes, confirming the program's adaptability and relevance, with thematic saturation achieved after 15 interviews, indicating strong acceptance and potential efficacy of this innovative treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Validation of a Novel VR Program for Irritable Bowel Syndrome: A VR1 Study. Spiegel, BMR., Liran, O., Gale, R., et al.[2022]

A pilot study involving 62 children and young adults with Inflammatory Bowel Disease (IBD) showed that a Mindfulness-Based Virtual Reality (MBVR) intervention was highly feasible and acceptable, with participants reporting high satisfaction and relaxation levels after the 6-minute session.

Preliminary results indicated that MBVR significantly reduced anxiety and pain in participants, suggesting it could be an effective complementary approach for managing psychological and physical symptoms associated with IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Virtual Reality Intervention for Children and Young Adults with Inflammatory Bowel Disease: A Pilot Feasibility and Acceptability Study. Wren, AA., Neiman, N., Caruso, TJ., et al.[2021]

Irritable bowel syndrome (IBS) affects about 20% of the global population and is characterized by chronic abdominal pain and altered bowel habits, with its pathophysiology linked to dysregulation of the brain-gut axis.

Current treatments for IBS include traditional symptomatic therapies and novel approaches targeting neurotransmitter receptors, such as 5-HT3 antagonists for diarrhea and 5-HT4 agonists for constipation, highlighting the importance of understanding gut-brain communication in developing effective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The brain-gut axis in irritable bowel syndrome--clinical aspects. Mach, T.[2022]

Virtual reality (VR) has been found to be an effective method for reducing both acute and chronic pain, with significant improvements in pain intensity (72.1%) and quality (75.0%) observed across 70 studies involving 4105 participants.

The primary mechanism of pain relief through VR is distraction, especially for acute pain, while embodiment is more commonly associated with chronic pain, indicating that different types of pain may benefit from tailored VR approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The State of Science in the Use of Virtual Reality in the Treatment of Acute and Chronic Pain: A Systematic Scoping Review. Baker, NA., Polhemus, AH., Haan Ospina, E., et al.[2023]

In a study involving 103 hospitalized patients, both standard animated CGI VR and Video Capture VR significantly reduced pain by about 50% compared to a waitlist control group, with effects maintained at follow-up.

While both VR types were equally effective in pain reduction, patients found Video Capture VR to be more realistic and enjoyable, suggesting it may enhance the overall experience of pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic Pain Management Among Hospitalized Inpatients: A Randomized Waitlist-Controlled Trial of Standard Virtual Reality (CGI VR) Versus Video Capture VR (360 degrees 3D/Stereoscopic Video Capture VR). Powers, MB., Carl, E., Levihn-Coon, A., et al.[2023]

A study involving 45 adults with social anxiety disorder (SAD) demonstrated that both traditional cognitive-behavioral therapy (CBT) and a combined CBT with virtual reality (CBT-VR) significantly reduced anxiety levels compared to a waiting list group.

The results indicate that CBT treatments, including innovative approaches like CBT-VR, are effective for managing social anxiety, suggesting that these methods can be beneficial for individuals beyond just fear of public speaking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using virtual humans to alleviate social anxiety: preliminary report from a comparative outcome study. Robillard, G., Bouchard, S., Dumoulin, S., et al.[2019]

An 8-week home-based therapeutic virtual reality (VR) program significantly reduced pain intensity and improved various pain-related factors (like activity and stress) compared to a Sham VR program, with effects lasting up to 3 months after treatment in adults with chronic low back pain.

The therapeutic VR program demonstrated sustained benefits and maintained superiority over Sham VR for most outcomes, indicating its potential as an effective long-term pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Month Follow-Up Results of a Double-Blind, Randomized Placebo-Controlled Trial of 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR) for Chronic Low Back Pain. Garcia, LM., Birckhead, BJ., Krishnamurthy, P., et al.[2022]

This study demonstrates that immersive virtual reality (VR) can significantly increase heat-pain tolerance limits in healthy participants, suggesting its potential as a nonpharmacological intervention for pain management.

VR not only enhances pain tolerance but also improves mood and reduces situational anxiety when the experience is enjoyable, although these mood changes do not directly affect pain tolerance levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality: physiological and behavioral mechanisms to increase individual pain tolerance limits. Colloca, L., Raghuraman, N., Wang, Y., et al.[2022]

The study involving 60 patients showed that using virtual reality during colonoscopy significantly reduced pain levels compared to standard procedures, indicating its efficacy as a pain management tool.

While virtual reality did not significantly affect anxiety levels before and after the procedure, it was associated with a notable reduction in trait anxiety scores, suggesting it may help patients feel more comfortable during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Virtual Reality on Pain and Anxiety During Colonoscopy: A Randomized Controlled Trial. Karaveli Çakır, S., Evirgen, S.[2022]

Active virtual reality (VR) therapy significantly improved symptoms of functional dyspepsia compared to sham VR, with a notable mean difference in symptom severity scores over a 2-week period.

The study found that VR was safe, with only one patient withdrawing due to nonserious adverse effects, suggesting it could be a beneficial treatment option for managing dyspepsia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. Cangemi, DJ., Montenegro, M., Spiegel, BMR., et al.[2023]

Disorders of gut-brain interaction (DGBIs), such as functional dyspepsia and irritable bowel syndrome (IBS), are common and significantly impact patients' quality of life, highlighting the need for effective treatments.

Recent studies suggest that virtual reality (VR) technology may be a promising novel therapy for alleviating chronic abdominal pain associated with DGBIs, potentially offering a non-invasive alternative to traditional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? Lacy, BE., Cangemi, DJ., Spiegel, BR.[2023]

Virtual reality (VR) therapies have shown promise in effectively distracting patients from both acute and chronic pain, suggesting a new approach to pain management beyond traditional methods like opioids and physical therapy.

Clinical studies indicate that VR can be beneficial for various pain conditions, including fibromyalgia and phantom limb pain, by immersing patients in interactive environments that reduce their perception of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. Pourmand, A., Davis, S., Marchak, A., et al.[2018]

A meta-analysis of 30 studies found that virtual reality (VR) psychological interventions have a moderate overall effect size, indicating they can be effective treatments for psychological conditions.

VR interventions showed a large effect size compared to non-intervention wait-lists and a moderate effect size compared to active interventions, suggesting they are promising options for psychological treatment despite variability in study methodologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes associated with virtual reality in psychological interventions: where are we now? Turner, WA., Casey, LM.[2014]

This study is evaluating the effectiveness of guided relaxation-based virtual reality (VR-GR) compared to distraction-based VR (VR-D) and a passive control (360 video) in managing pain for 90 children and adolescents undergoing surgery, with a focus on pain intensity and related psychological factors.

The trial aims to determine if VR-GR can provide more lasting pain relief than traditional distraction methods, potentially reducing the need for opioid and benzodiazepine medications post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). Olbrecht, VA., Williams, SE., O'Conor, KT., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06687616

Study Details | NCT06687616 | RCT of VR Therapy for IBS Through a pilot randomized controlled trial (RCT), the aim is to test the clinical impact and feasibility of a virtual reality (VR) cognitive behavioral ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11401788/

The Role of Virtual Reality in the Management of Irritable ... This article explores the potential role of virtual reality (VR)-based cognitive behavioral therapy (CBT) in treating patients with IBS.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06257472/efficacy-of-virtual-reality-vr-for-irritable-bowel-syndrome

Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome The primary aim of this study will be to assess the benefits of disease-targeted VR compared to sham VR on clinically relevant outcomes. ... VR ...

4. withpower.com withpower.com/trial/phase-irritable-bowel-syndrome-11-2024-d986b

VR Therapy for Irritable Bowel Syndrome It is hypothesized that using VR-administered CBT may reduce abdominal pain, leading to improved overall physical, psychological, and social functioning when ...

5. cedars-sinai.org cedars-sinai.org/newsroom/study-virtual-reality-helps-ibs-patients/

Study: Virtual Reality Helps IBS Patients A home-based virtual reality (VR) program developed by Cedars-Sinai investigators to help patients with irritable bowel syndrome (IBS) pain received positive ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06687616/rct-of-vr-therapy-for-ibs

RCT of VR Therapy for IBS | Clinical Research Trial Listing The study will follow the established NIH protocol for conducting VR clinical trials, which aligns with VR-CORE clinical trial guidance.

7. withpower.com withpower.com/trial/phase-irritable-bowel-syndrome-1-2024-00f8c

Virtual Reality for Irritable Bowel Syndrome While detailed safety information for VR treatments in IBS is lacking, VR is generally regarded as a safe and well-tolerated therapeutic method. The available ...

8. ctv.veeva.com ctv.veeva.com/study/rct-of-vr-therapy-for-ibs

RCT of VR Therapy for IBS - ClinicalTrials.Veeva The study will follow the established NIH protocol for conducting VR clinical trials, which aligns with VR-CORE clinical trial guidance.