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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 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

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

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,400 Previous Clinical Trials

17,341,689 Total Patients Enrolled

7 Trials studying Food Allergy

1,229 Patients Enrolled for Food Allergy

Sayantani Sindher, MDPrincipal InvestigatorStanford University

4 Previous Clinical Trials

1,370 Total Patients Enrolled

1 Trials studying Food Allergy

800 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical trial accept participants who are elderly (over 45 years old)?

"This medical trial has a specified age range for enrollment, with the minimum being 5 years old and the maximum being 17."

Answered by AI

Who is eligible to participate in this research trial?

"To qualify for this research project, prospective participants should be aged 5 to 17 and have pediatric food allergies. Around 59 individuals are being sought for the study."

Answered by AI

Is enrollment for this trial open at present?

"Based on the information provided by clinicaltrials.gov, this experiment is no longer seeking to enrol participants. Initially published on February 1st 2021 and last modified in October 17th 2022, there are 262 other studies currently recruiting patients instead of this one."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge

Sayantani B. Sindher 2021. "Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04376242.

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