Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge

Food Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376242
• Other study ID #: 56108
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Allergy in Children
• Food Hypersensitivity
• Hypersensitivity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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)
Secondary	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)