Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge

NCT04376242 | Terminated

• 1 other identifier: 56108
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Food Allergy in Children; Food Allergy

Keywords

food allergy; oral food challenge; virtual reality

Outcome Measures

Primary Outcomes (2)

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

  The Children's Fear Scale (CFS) is used to measure the anxiety or fear level of the children. The one-item scale consists of a row of five sex neutral faces ranging from a no fear (neutral) face on the far left to a face showing extreme fear on the far right.

  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.

• Change in Childhood Anxiety Meter Score Before and After OFC dosing

  The Childhood Anxiety Meter brief measure of the current level of anxiety in a child using a visual scale (thermometer that is colored to the level anxiety, higher thermometer level means more anxiety).

  Before and after each evaluation (approximately 4-6 hours between measurements at each visit, with visits approximately 1 week apart)

Secondary Outcomes (2)

• Level of Immersion after OFC

  After each evaluation (approximately 1 week apart)

• Level of satisfaction - participant, caregiver and provider

  After each evaluation (approximately 1 week apart)

Study Arms (2)

virtual reality then standard technology

EXPERIMENTAL

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

Behavioral: use of virtual reality; Behavioral: use of standard technology

standard technology then virtual reality

ACTIVE COMPARATOR

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

Behavioral: use of virtual reality; Behavioral: use of standard technology

Interventions

use of virtual reality BEHAVIORAL

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.

standard technology then virtual reality; virtual reality then standard technology

use of standard technology BEHAVIORAL

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.

standard technology then virtual reality; virtual reality then standard technology

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between the ages of 5 and 17
• Willing to participate in both the VR and standard of care technology conditions
• Able to consent or have parental consent
• Undergoing at least two Oral Food Challenges within the window of recruitment at the Sean N. Parker Center

You may not qualify if:

• People who do not consent
• Significant Cognitive Impairment
• History of Severe Motion Sickness
• Current Nausea
• Seizures
• Visual Problems
• Non-English Speaking
• Patients who clinically unstable or requires urgent/emergent intervention
• ASA class 4 or higher

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sayantani Sindher, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 6, 2020
• Study Start: February 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)