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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
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

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 5 and 17 years old.

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.
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Childhood Anxiety Meter Score Before and After OFC dosing
Change in Children's Fear Scale Score Before and After OFC dosing
Secondary outcome measures
Level of Immersion after OFC
Level of satisfaction - participant, caregiver and provider

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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,408 Previous Clinical Trials
17,343,312 Total Patients Enrolled
7 Trials studying Food Allergy
1,429 Patients Enrolled for Food Allergy
Sayantani Sindher, MDPrincipal InvestigatorStanford University
4 Previous Clinical Trials
1,570 Total Patients Enrolled
1 Trials studying Food Allergy
1,000 Patients Enrolled for Food Allergy
William J Collins, MDPrincipal InvestigatorStanford University

Media Library

use of virtual reality Clinical Trial Eligibility Overview. Trial Name: NCT04376242 — N/A
Food Allergy Research Study Groups: standard technology then virtual reality, virtual reality then standard technology
Food Allergy Clinical Trial 2023: use of virtual reality Highlights & Side Effects. Trial Name: NCT04376242 — N/A
use of virtual reality 2023 Treatment Timeline for Medical Study. Trial Name: NCT04376242 — N/A
~38 spots leftby Sep 2025
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