Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge

NCT ID: NCT04376242

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

use of virtual reality

Intervention Type: 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.

use of standard technology

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

use of virtual reality

Intervention Type: 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.

use of standard technology

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sayantani B. Sindher

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sayantani Sindher, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

56108

Identifier Type: -

Identifier Source: org_study_id