Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge

The Utilization of Virtual Reality Technology Versus Standard of Care During Pediatric Oral Food Challenge: A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Food Allergy; Food Allergy in Children
• Intervention / Treatment: Behavioral: use of virtual reality; Behavioral: use of standard technology

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: Study Team; Phone Number: 650-521-7237; Email: snpcenterallergy_inquiry@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality then standard technology; 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; 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.
Active Comparator: standard technology then virtual reality; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Immersion after OFC	Modified scale to assess cognitive absorption as a measure of immersion in the technology.	After each evaluation (approximately 1 week apart)
Level of satisfaction - participant, caregiver and provider	Patient, caregiver and provider satisfaction after dosing will be assessed through a custom satisfaction evaluation form, with categorical responses to questions tailored to specific challenges during OFC such as the time it takes to administer a dose, how well a patient complies with dosing, and how available technology may influence patient and caregiver desire to continue with a study.	After each evaluation (approximately 1 week apart)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Sayantani Sindher, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: virtual reality; food allergy; oral food challenge
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 56108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No