Virtual Reality for Food Allergy Challenges

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Cognitive impairment, Motion sickness, Seizures, others

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

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if virtual reality (VR) can reduce anxiety and fear in children with food allergies during oral food challenges (OFCs). Researchers will compare VR with standard methods, such as watching TV or using personal devices. Participants will experience both approaches during separate OFCs to identify which is more effective. This trial may suit children aged 5 to 17 who experience anxiety during OFCs and are scheduled for at least two challenges. As an unphased trial, it offers a unique opportunity for participants to explore innovative ways to manage anxiety.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that virtual reality technology is safe for pediatric patients undergoing oral food challenges?

Research has shown that virtual reality (VR) is usually well-received in similar situations. In studies where VR helped reduce anxiety and fear during medical procedures like blood tests, no major negative side effects or safety problems were reported. VR is a non-invasive tool, meaning it doesn't physically touch or affect the body, which generally ensures safety. Although this study doesn't focus on safety, using VR in medical settings has proven to be a safe way to help manage anxiety in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality for food allergy challenges because it offers a novel approach to managing patient anxiety during oral food challenges. Unlike traditional methods, which rely on standard technology to monitor and support patients, virtual reality can immerse individuals in calming environments, potentially reducing stress and improving their overall experience. This innovative technique could lead to more accurate assessments of food allergies by creating a more comfortable and controlled setting for patients.

What evidence suggests that this trial's treatments could be effective for reducing anxiety and fear in pediatric patients undergoing oral food challenges?

Research has shown that virtual reality can reduce anxiety and fear. In studies, virtual reality places users in a game-like setting, which engages them more than watching TV or using a phone. This engaging experience distracts the brain from stress during medical procedures. Some studies found that virtual reality reduced anxiety during dental work or blood tests. In this trial, participants will experience both virtual reality and standard technology during oral food challenges. While more research is needed for food allergy tests, the potential benefits of virtual reality in reducing anxiety appear promising. ^{1 2 3 4 6}

Who Is on the Research Team?

Sayantani Sindher, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for kids aged 5-17 with food allergies who are undergoing oral food challenges and can consent or have parental consent. They must be willing to try both VR and standard tech during the test. It's not for those with seizures, severe motion sickness, nausea, visual or cognitive issues, non-English speakers, or anyone too sick for a non-emergency study.

Inclusion Criteria

I am willing to try both VR and standard treatments.

I am participating in at least two food challenges at the Sean N. Parker Center during the recruitment period.

I am between 5 and 17 years old.

Exclusion Criteria

My health is severely limited by my illness.

I am currently experiencing nausea.

I am not in urgent need of medical care for my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo oral food challenges using either standard technology or virtual reality, with each challenge approximately one week apart

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for anxiety and fear levels before and after each oral food challenge

1 week

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• use of standard technology
• use of virtual reality

Trial Overview The study is testing if virtual reality headsets help reduce anxiety better than normal distractions like TV or personal devices during food allergy tests in children. Each child will experience both the new VR method and the usual way on different visits.

How Is the Trial Designed?

Group I: virtual reality then standard technology Experimental Treatment 2 Interventions

patients randomized to this arm will first use virtual reality (VR) during and oral food challenge and then use standard technology during a second oral food challenge

Group II: standard technology then virtual reality Active Control 2 Interventions

patients randomized to this arm will first use standard technology during and oral food challenge and then use virtual reality during a second oral food challenge

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Virtual reality exposure therapy (VRET) was found to be more effective than no treatment for patients with panic disorder and agoraphobia, indicating its potential as a therapeutic intervention.

There was no significant difference in treatment outcomes between VRET delivered through a head-mounted display (HMD) and a computer automatic virtual environment (CAVE), suggesting that both methods are equally effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure treatment of agoraphobia: a comparison of computer automatic virtual environment and head-mounted display. Meyerbröker, K., Morina, N., Kerkhof, G., et al.[2011]

Virtual reality (VR) can be an innovative tool in marketing research to influence food choices and promote healthier eating habits, potentially countering the marketing of unhealthy foods.

Interviews with experts highlight the use of virtual grocery stores to educate students about nutrition and the relationship between food quality and health, which could aid in addressing obesity and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New directions in the use of virtual reality for food shopping: marketing and education perspectives. Ruppert, B.[2021]

In a study involving 49 pediatric patients undergoing phlebotomy for food allergy diagnosis, those using virtual reality (VR) experienced significantly less anxiety and fear during the procedure compared to those receiving standard care.

The VR group also reported lower pain levels and demonstrated better procedural compliance, suggesting that interactive VR applications can effectively improve the experience of pediatric patients during potentially stressful medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Reduces Pediatric Anxiety During Food Allergy Clinical Trials: A Pilot Randomized, Pragmatic Study. Alonzi, S., Caruso, TJ., Sindher, SB., et al.[2022]

Virtual reality (VR) is emerging as a promising therapeutic tool for patients with eating disorders, allowing for immersive experiences that can help assess and manage their conditions.

The review analyzed 26 studies, including randomized controlled trials and clinical trials, highlighting VR's effectiveness in addressing body image issues and exposure to high-calorie foods, making it a valuable addition to traditional treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality in Patients with Eating Disorders: Systematic Review. Clus, D., Larsen, ME., Lemey, C., et al.[2019]

Virtual Reality exposure therapy (VRET) has been proven effective in reducing fear and anxiety through decades of research and over 20 randomized controlled trials, but access has been limited due to the high cost of equipment.

Recent advancements in consumer VR technology, like Oculus Rift and Samsung Gear, now allow for broader implementation of VRET in clinical settings and self-help applications, making it more accessible for both providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating state of the art, next-generation Virtual Reality exposure therapies for anxiety disorders using consumer hardware platforms: design considerations and future directions. Lindner, P., Miloff, A., Hamilton, W., et al.[2018]

Interactive virtual reality (VR) environments using head-mounted displays show promise as a therapeutic tool for treating eating disorders, with new therapy forms emerging from technologies like 360 cameras and eye-tracking.

Future research should focus on larger sample sizes and more rigorous testing methods, including control groups and follow-up measures, to better understand the efficacy and potential of VR interventions for eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Various Types of Virtual Reality-Based Therapy for Eating Disorders: A Systematic Review. Ciążyńska, J., Maciaszek, J.[2022]

A single-session automated Virtual Reality exposure therapy (VRET) for fear of spiders demonstrated a significant reduction in phobia symptoms (effect size d = 1.26) in a study of 25 participants, with effects maintained at a six-month follow-up.

The intervention was found to be practical and tolerable, suggesting that automated VRET could serve as an effective self-help treatment for specific phobias in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamified, Automated Virtual Reality Exposure Therapy for Fear of Spiders: A Single-Subject Trial Under Simulated Real-World Conditions. Lindner, P., Miloff, A., Bergman, C., et al.[2022]

Immersive virtual reality (VR) technology has the potential to enhance research and therapy for eating and weight disorders, but its widespread use is still limited due to the complexity and cost of developing effective VR setups.

To maximize the benefits of VR in psychotherapy, a user-centered design approach is essential, focusing on the unique features of VR to create tailored environments that improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How immersive virtual reality can become a key tool to advance research and psychotherapy of eating and weight disorders. Behrens, SC., Streuber, S., Keizer, A., et al.[2022]

A study involving 100 hospitalized patients showed that a one-time 3D virtual reality (VR) intervention significantly reduced pain more than a 2D distraction video, with an average pain reduction of -1.3 points compared to -0.6 points for the control group.

The VR intervention was not only effective, with 65% of patients experiencing a meaningful pain response, but it was also safe, as no adverse events were reported during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. Tashjian, VC., Mosadeghi, S., Howard, AR., et al.[2020]

A systematic review of 21 studies involving children undergoing needle procedures found that virtual reality (VR) significantly reduces both pain and fear compared to standard distraction techniques, with a notable effect size for pain reduction (P<.001).

Despite the overall low methodological quality of the studies, the findings support the effectiveness of VR as a distraction tool during painful procedures, highlighting its potential to improve the experience for children in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality on Pediatric Pain and Fear During Procedures Involving Needles: Systematic Review and Meta-analysis. Lluesma-Vidal, M., Carcelén González, R., García-Garcés, L., et al.[2022]

In a study involving 55 pediatric patients undergoing venipuncture, the use of off-the-shelf virtual reality (VR) games resulted in longer procedure times compared to traditional child life support, primarily due to troubleshooting issues with the VR games (average increase of 4-6 minutes).

While VR therapy can help reduce pain and anxiety during medical procedures, its implementation requires careful consideration of additional resources, such as dedicated staff for assistance and the potential costs associated with the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resource Use During Pediatric Venipuncture With Virtual Reality: Secondary Analysis of a Randomized Controlled Pilot Trial. Canares, TL., Parrish, C., Santos, C., et al.[2021]

A randomized clinical trial involving 88 children aged 6 months to 4 years showed that using a virtual reality (VR) environment with a domed ceiling screen significantly reduced pain and distress during intravenous (IV) placement compared to standard care.

Children in the VR group had lower pain scores (median FLACC score of 6.0) compared to the control group (median FLACC score of 7.0), indicating that VR can be an effective distraction method for young patients during painful procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Virtual Reality Environment Using a Domed Ceiling Screen on Procedural Pain During Intravenous Placement in Young Children: A Randomized Clinical Trial. Lee, HN., Park, JW., Hwang, S., et al.[2023]

A systematic review of 25 studies over the past 20 years highlights the growing use of virtual reality (VR) applications in addressing body image issues in patients with Anorexia Nervosa (AN), indicating a shift towards more accessible and effective treatment tools.

The review suggests that incorporating biofeedback techniques with VR could enhance therapeutic interventions for adolescents with AN, potentially improving treatment outcomes by providing real-time feedback on body representation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anorexia Nervosa, Body Image Perception and Virtual Reality Therapeutic Applications: State of the Art and Operational Proposal. Magrini, M., Curzio, O., Tampucci, M., et al.[2022]

This study will compare the effectiveness of traditional one-session exposure therapy (OST) with a new gamified virtual reality (VR) exposure therapy for treating spider phobia in 100 participants, assessing outcomes at multiple time points up to a year after treatment.

The use of VR therapy aims to improve accessibility and engagement in treatment, potentially making it a more effective and acceptable option for individuals reluctant to seek traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-session gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial. Miloff, A., Lindner, P., Hamilton, W., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04376242

Study Details | NCT04376242 | Virtual Reality Technology ... The intervention is a virtual reality program designed to immerse participants in a gaming experience to improve anxiety and fear during an oral food challenge.

2. trials.foodallergy.org trials.foodallergy.org/trials/NCT04376242

Virtual Reality Technology Versus ... - Clinical Trial Finder The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care of ...

3. stanfordhealthcare.org stanfordhealthcare.org/trials/v/NCT04376242.html

Virtual Reality Technology Versus Standard ... Purpose. The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of ...

4. withpower.com withpower.com/trial/phase-food-hypersensitivity-1-2021-f3770

Virtual Reality for Food Allergy Challenges · Info for Participants The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care of ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04376242?keyword=%22Food%22

San Mateo Clinical Trial Virtual Reality Technology Versus ... The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8974765/

Virtual Reality Reduces Pediatric Anxiety During Food ... Interactive VR applications may be an effective tool for reducing fear, anxiety, and pain during phlebotomy for FA clinical trials.