VR Therapy for Irritable Bowel Syndrome
Recruiting in Palo Alto (17 mi)
+1 other location
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Christopher Almario
Must not be taking: Opioids
Disqualifiers: Seizure history, Cognitive impairment, Celiac, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
1112131415Eligibility 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
+1 more
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.
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SynerGIExperimental Treatment1 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 VRPlacebo Group1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cedars-Sinai Medical CenterLos Angeles, CA
Cleveland ClinicCleveland, OH
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Who Is Running the Clinical Trial?
Christopher AlmarioLead Sponsor
The Cleveland ClinicCollaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Virtual Reality as a Clinical Tool for Pain Management. [2018]To evaluate the use of virtual reality (VR) therapies as a clinical tool for the management of acute and chronic pain.
Outcomes associated with virtual reality in psychological interventions: where are we now? [2014]The impending commercial release of affordable VR systems is likely to accelerate both the opportunity and demand for VR applications that specifically target psychological conditions. The aim of this study was to conduct a meta-analysis of outcomes associated with VR psychological interventions and to examine the methodological rigour used in these interventions. Literature search was conducted via Ovid, ProQuest Psychology Journals and ScienceDirect (Psychology) databases. Interventions were required to: be published between 1980 to 2014; use a randomised controlled trial design; be published in a scholarly journal; focused primarily on psychological/behavioural intervention; include validated measures; include reported means and standard deviations of outcome measures; and include one group with clinical/subclinical disorders, syndromes or distressing behaviours. Thirty eligible studies were identified. Random effects meta-analysis found an overall moderate effect size for VR interventions. Individual meta-analyses found an overall large effect size against non-intervention wait-lists and an overall moderate effect size against active interventions. No correlation was found between treatment outcomes and methodological rigour. Limitations may include limited study numbers, the use of a single coder, a need for more in-depth analyses of variation in form VR intervention, and omission of presence as a moderating factor. The current review supports VR interventions as efficacious, promising forms of psychological treatment. Use of reporting guidelines such as the CONSORT and CONSORT-EHEALTH statements should promote greater emphasis on methodological rigour, providing a firm foundation for the further development of clinical VR applications.
Using virtual humans to alleviate social anxiety: preliminary report from a comparative outcome study. [2019]Empirical studies have consistently shown the effectiveness of a multicomponent CBT treatment of social anxiety disorder (SAD). Previous outcome studies on virtual reality and SAD have focused on people suffering from fear of public speaking and not full blown SAD. In this study, 45 adults receiving a DSM-IV-TR diagnostic of social anxiety were randomly assigned to traditional CBT treatment (with in vivo exposure), CBT-VR combined treatment, or a waiting list. Results show significant reduction of anxiety on all questionnaires as well as statistically significant interactions between both treatment groups and the waiting list.
Virtual reality: physiological and behavioral mechanisms to increase individual pain tolerance limits. [2022]Immersive virtual reality (VR) consists of immersion in artificial environments through the use of real-time render technologies and the latest generation devices. The users feel just as immersed as they would feel in an everyday life situation, and this sense of presence seems to have therapeutic potentials. However, the VR mechanisms remain only partially known. This study is novel in that, for the first time in VR research, appropriate controls for VR contexts, immersive characteristics (ie, control VR), and multifaceted objective and subjective outcomes were included in a within-subject study design conducted on healthy participants. Participants received heat thermal stimulations to determine how VR can increase individual heat-pain tolerance limits (primary outcome) measured in degrees Celsius and seconds while recording concurrent autonomic responses. We also assessed changes in pain unpleasantness, mood, situational anxiety, and level of enjoyment (secondary outcomes). The VR induced a net gain in heat-pain tolerance limits that was paralleled by an increase of the parasympathetic responses. VR improved mood, situational anxiety, and pain unpleasantness when participants perceived the context as enjoyable, but these changes did not influence the increases in pain tolerance limits. Distraction increased pain tolerance limits but did not induce such mood and physiological changes. Immersive VR has been anecdotally applied to improve acute symptoms in contexts such as battlefield, emergency, and operating rooms. This study provides a mechanistic framework for VR as a low-risk, nonpharmacological intervention, which regulates autonomic, affective (mood and situational anxiety), and evaluative (subjective pain and enjoyment ratings) responses associated with acute pain.
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]Prior work established post-treatment efficacy for an 8-week home-based therapeutic virtual reality (VR) program in a double-blind, parallel arm, randomized placebo-controlled study. Participants were randomized 1:1 to 1 of 2 56-day VR programs: 1) a therapeutic immersive pain relief skills VR program; or 2) a Sham VR program within an identical commercial VR headset. Immediate post-treatment results demonstrated clinically meaningful and superior reduction for therapeutic VR compared to Sham VR for average pain intensity, indices of pain-related interference (activity, mood, stress but not sleep), physical function, and sleep disturbance. The objective of the current report was to quantify treatment effects to post-treatment month 3 and describe durability of effects. Intention-to-treat analyses revealed sustained benefits for both groups and superiority for therapeutic VR for pain intensity and multiple indices of pain-related interference (activity, stress, and newly for sleep; effect sizes ranged from drm = .56-.88) and physical function from pre-treatment to post-treatment month 3. The between-group difference for sleep disturbance was non-significant and pain-interference with mood did not survive multiplicity correction at 3 months. For most primary and secondary outcomes, treatment effects for therapeutic VR showed durability, and maintained superiority to Sham VR in the 3-month post-treatment period. PERSPECTIVE: We present 3-month follow-up results for 8-week self-administered therapeutic virtual reality (VR) compared to Sham VR in adults with chronic low back pain. Across multiple pain indices, therapeutic VR had clinically meaningful benefits, and superiority over Sham VR. Home-based, behavioral skills VR yielded enduring analgesic benefits; longer follow-up is needed.
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]Virtual reality (VR) offers an innovative method to deliver non-pharmacological pain management. Distraction-based VR (VR-D) using immersive games to redirect attention has shown short-term pain reductions in various settings. To create lasting pain reduction, VR-based strategies must go beyond distraction. Guided relaxation-based VR (VR-GR) integrates pain-relieving mind-body based guided relaxation with VR, a novel therapy delivery mechanism. The primary aim of this study is to assess the impact of daily VR-GR, VR-D and 360 video (passive control) on pain intensity. We will also assess the impact of these interventions on pain unpleasantness, anxiety and opioid and benzodiazepine consumption. The secondary aim of this study will assess the impact of psychological factors (anxiety sensitivity and pain catastrophising) on pain following VR.
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]Nonpharmacologic pain management strategies are needed because of the growing opioid epidemic. While studies have examined the efficacy of virtual reality (VR) for pain reduction, there is little research in adult inpatient settings, and no studies comparing the relative efficacy of standard animated computer-generated imagery (CGI) VR to Video Capture VR (360 degrees 3D/stereoscopic Video Capture VR). Here, we report on a randomized controlled trial of the relative efficacy of standard CGI VR versus Video Capture VR (matched for content) and also compared the overall efficacy of VR to a waitlist control group.
Virtual reality interventions to reduce psychological distress during colonoscopy: a rapid review. [2023]Colonoscopy can cause psychological distress in patients, consequently discouraging patients from undergoing an unpleasant procedure or reducing compliance with follow-up examinations. This rapid review aimed to assess the feasibility and efficacy of Virtual Reality (VR) interventions during colonoscopy on patients' perceived psychological distress and procedure satisfaction.
The Effect of Virtual Reality on Pain and Anxiety During Colonoscopy: A Randomized Controlled Trial. [2022]The aim of the study is to evaluate the effect of virtual reality application during a colonoscopy on the pain and anxiety experienced by patients.
The State of Science in the Use of Virtual Reality in the Treatment of Acute and Chronic Pain: A Systematic Scoping Review. [2023]Previous reviews have reported virtual reality (VR) to be an effective method to treat pain. This scoping review examines the state of the science for VR and pain both generally and by pain type (acute and chronic) related to types of mechanisms, dosage, effectiveness, and adverse events (AEs). We searched online databases PubMed, Web of Science, PsychInfo, and CINAHL from 2010 to 2020 and included studies from peer reviewed journals that examined people with pain, (excluding pain-free participants) with a primary outcome measuring pain. We assessed studies for risk of bias using PEDro criteria. We described data through counts and percentages. Significant results were determined through P-values. We found 70 studies representing 4105 people; 46 acute pain studies (65.7%), 22 chronic pain studies (31.4%), and 2 (2.9%) "both." The most common VR mechanism was distraction (78.6%) then embodiment (17.1%). However, distraction was the mechanism for 97.8% acute pain studies while embodiment was more common for chronic pain (54.5%). Dosage of VR was inconsistently reported and varied considerably. VR treatment groups showed significant improvements in pain, particularly for intensity of pain (72.1%) and quality of pain (75.0%). Few studies examined AEs. Limitations of this review include only examining last 10 years of articles and that many studies were missing data. VR appears to be an effective intervention to address both acute and chronic pain. Research evaluating VR mechanisms, dosage, and AEs is warranted, as is further work in under-served populations (children for chronic pain and older adults) as the current evidence is largely limited to adult populations with pain.
Qualitative Validation of a Novel VR Program for Irritable Bowel Syndrome: A VR1 Study. [2022]Although gut-directed psychotherapies are effective for irritable bowel syndrome (IBS), they are rarely prescribed, given a paucity of trained clinicians. Virtual reality (VR) offers a solution by allowing patients to self-practice these techniques in a standardized manner.
Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Double-Blind, Sham-Controlled, Pilot Study. [2023]We investigated the efficacy and safety of virtual reality (VR) for functional dyspepsia.
Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? [2023]Disorders of gut-brain interaction (DGBIs), previously called functional bowel disorders, are prevalent, reduce patients' quality of life, and impose a significant negative economic impact on the health care system. Functional dyspepsia and irritable bowel syndrome (IBS) are 2 of the most common DGBIs. An overlying, and in many cases unifying, symptom for many of these disorders is the presence of abdominal pain. Chronic abdominal pain can be difficult to treat, as many antinociceptive agents are associated with side effects that limit their use and other agents may only partially improve, but not completely relieve, all aspects of the pain. Novel therapies to alleviate chronic pain and the other symptoms that characterize DGBIs are thus needed. Virtual reality (VR), a technology that immerses patients in a multisensory experience, has been shown to relieve pain in burn victims and other instances of somatic pain. Two recent novel studies have demonstrated that VR has the potential to play an important role in the treatment of functional dyspepsia and IBS. This article examines the development of VR, its role in the treatment of somatic and visceral pain, and its potential position in the treatment of DGBIs.
Mindfulness-Based Virtual Reality Intervention for Children and Young Adults with Inflammatory Bowel Disease: A Pilot Feasibility and Acceptability Study. [2021]The aim of this pilot study was to assess: (1) the feasibility and acceptability of a Mindfulness-Based Virtual Reality (MBVR) intervention among children and young adults with Inflammatory Bowel Disease (IBD), and (2) the preliminary efficacy of MBVR on key psychological (anxiety) and physical (pain) outcomes. Participants were 62 children to young adults with IBD (M = 15.6 years; 69.4% Crohn's disease; 58% male) recruited from an outpatient pediatric IBD clinic. Participants completed a baseline assessment, underwent the 6-min MBVR intervention, completed a post-intervention assessment and study satisfaction survey, and provided qualitative feedback. Results suggest strong feasibility and acceptability. Participants reported high levels of satisfaction with MBVR including high levels of enjoyment (M = 4.38; range 1-5) and relaxation (M = 4.35; range 1-5). Qualitative data revealed several key themes including participants interest in using MBVR in IBD medical settings (e.g., hospitalizations, IBD procedures, IBD treatments), as well as in their daily lives to support stress and symptom management. Preliminary analyses demonstrated improvements in anxiety (t = 4.79, p = 0.001) and pain (t = 3.72, p < 0.001) following MBVR. These findings provide initial support for the feasibility and acceptability of MBVR among children and young adults with IBD. Results also suggest MBVR may improve key IBD outcomes (e.g., anxiety, pain) and highlight the importance of conducting a randomized controlled trial and more rigorous research to determine intervention efficacy.
The brain-gut axis in irritable bowel syndrome--clinical aspects. [2022]Irritable bowel syndrome (IBS) is the most common chronic gastrointestinal (GI) disorder, affecting about 20% of the world's population. Chronic abdominal pain or discomfort relieved by defecation and associated with altered bowel habits are the mainstay in diagnosis. The pathophysiology of IBS remains unknown. This biopsychosocial disorder involves dysregulation of the nervous system, altered intestinal motility, and increased visceral sensitivity. All of these result from dysregulation of the bidirectional communication between the gut with its enteric nervous system and the brain (the brain-gut axis), modulated by various psychosocial and environmental factors (e.g. infection, inflammation). Numerous neurotransmitters are found in the brain and gut that regulate GI activities, including 5-hydroxytryptamine (5-HT, serotonin) and its 5-HT3 and 5-HT4 receptors. The current approach to IBS patients is based on a positive diagnosis of the symptom complex, exclusion of underlying organic disease, and institution of a therapeutic trial. Traditional symptomatic treatment has included antidiarrheals, laxatives and bulking agents/fiber, low-dose tricyclic antidepressants, antispasmodics for pain, and "alternative" therapies (e.g. psychotherapy, hypnotherapy). The scientific evidence supporting this therapy is limited. Novel approaches include visceral analgesics and serotonin agonists and antagonists. In patients with severe diarrhea, 5-HT3 receptor antagonists (e.g. alosetron) and selective M3-type anticholinergics are indicated, in constipation 5-HT4 agonists (e.g. tegaserod), and in pain alfa2-adrenergics (e.g. clonidine), cholecystokinin antagonists, kappa-opioid agonists (e.g. fedotozine), and neurokinin antagonists; some of these agents are still being investigated. Understanding the brain-gut axis is crucial in the development of effective therapies for IBS.