VR Therapy for Irritable Bowel Syndrome

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

72 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Sham VR, SynerGI for Irritable Bowel Syndrome?

Research shows that virtual reality (VR) treatments can effectively reduce pain and improve mood and anxiety in various conditions, such as chronic pain and social anxiety. This suggests that VR therapy, like Sham VR, SynerGI, might also help manage symptoms of Irritable Bowel Syndrome by providing similar benefits. ^{1 2 3 4 5}

Is VR therapy safe for humans?

Research on virtual reality (VR) therapy, including for pain management, shows it is generally safe for humans, but few studies have specifically looked at side effects. More research is needed to fully understand any potential adverse effects. ^{6 7 8 9 10}

How does the VR therapy SynerGI differ from other treatments for IBS?

SynerGI is unique because it uses virtual reality (VR) to allow patients to self-practice gut-directed psychotherapies, which are effective for IBS but often underutilized due to a lack of trained clinicians. This approach provides a standardized and accessible way for patients to manage their symptoms. ^{11 12 13 14 15}

What is the purpose of this trial?

Through a pilot randomized controlled trial (RCT), the aim is to test the clinical impact and feasibility of a virtual reality (VR) cognitive behavioral therapy (CBT) program versus sham VR among patients with irritable bowel syndrome (IBS). It is hypothesized that using VR-administered CBT may reduce abdominal pain, leading to improved overall physical, psychological, and social functioning when compared to sham VR.

Research Team

Christopher V Almario, MD, MSHPM

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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

I experience significant abdominal pain.

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

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 do not have any other health conditions that could be confused with IBS.

I take regular opioid medication.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes associated with virtual reality in psychological interventions: where are we now? [2014]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Using virtual humans to alleviate social anxiety: preliminary report from a comparative outcome study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Virtual reality: physiological and behavioral mechanisms to increase individual pain tolerance limits. [2022]

5. United States 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. [2022]

6. England 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). [2021]

7. United States 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). [2023]

8. England pubmed.ncbi.nlm.nih.gov

Virtual reality interventions to reduce psychological distress during colonoscopy: a rapid review. [2023]

9. Turkey pubmed.ncbi.nlm.nih.gov

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

10. United States 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Qualitative Validation of a Novel VR Program for Irritable Bowel Syndrome: A VR1 Study. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? [2023]

14. Switzerland 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. [2021]

15. United States pubmed.ncbi.nlm.nih.gov

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