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Virtual Reality for Food Allergy Challenges

N/A

Recruiting

Led By Sayantani Sindher, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 5 and 17

Be younger than 18 years old

Must not have

ASA class 4 or higher

Current Nausea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurements occur at single time points before and after each food challenge with approximately 4-6 hours between measurements. thus 4 discrete measurements will be taken over two food challenges which will occur approximately one week apart.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a VR headset can help kids and their caregivers feel less anxious during an oral food challenge, compared to standard treatments like watching TV or using personal electronic devices.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There may be risks of using VR such as dizziness, headaches, eye strain or worsening of pre-existing conditions like motion sickness; however these side effects are generally mild.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 5 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My health is severely limited by my illness.

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I am currently experiencing nausea.

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

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I have seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measurements occur at single time points before and after each food challenge with approximately 4-6 hours between measurements. thus 4 discrete measurements will be taken over two food challenges which will occur approximately one week apart.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measurements occur at single time points before and after each food challenge with approximately 4-6 hours between measurements. thus 4 discrete measurements will be taken over two food challenges which will occur approximately one week apart.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measurements occur at single time points before and after each food challenge with approximately 4-6 hours between measurements. thus 4 discrete measurements will be taken over two food challenges which will occur approximately one week apart. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Childhood Anxiety Meter Score Before and After OFC dosing

Change in Children's Fear Scale Score Before and After OFC dosing

Secondary study objectives

Level of Immersion after OFC

Level of satisfaction - participant, caregiver and provider

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: virtual reality then standard technologyExperimental Treatment2 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 realityActive Control2 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

0 / 5Eligibility criteria met