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Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge

NCT04376242 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-01-20

No results posted yet for this study

Summary

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 utilizing existing technologies that are currently more common in food allergy research treatment and clinics (i.e. television and patients' personal electronic devices) for decreasing levels anxiety and fear in pediatric patients undergoing oral food challenge (OFC) and their caregivers.

Conditions

Interventions

BEHAVIORAL

use of virtual reality

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.

BEHAVIORAL

use of standard technology

the active comparator group will be allowed standard technology for distraction during oral food challenge which can include TV, non-VR gaming, tablets and smart phones.

Sponsors & Collaborators

Principal Investigators

  • Sayantani Sindher, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04376242 on ClinicalTrials.gov