Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge

Stanford University57 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Food Allergy in Children Food Allergy

Interventions

use of virtual realityBEHAVIORAL

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.

use of standard technologyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

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

Secondary Outcomes

Level of Immersion after OFC

Modified scale to assess cognitive absorption as a measure of immersion in the technology.

Time frame: 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.

Time frame: After each evaluation (approximately 1 week apart)

Data from ClinicalTrials.gov

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