Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge

Stanford University

Status: Terminated

Conditions: Food Allergy; Food Allergy in Children

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04376242

56108

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

virtual reality then standard technology

Experimental group

Description:

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

Treatment:

Behavioral: use of standard technology

Behavioral: use of virtual reality

standard technology then virtual reality

Active Comparator group

Description:

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

Treatment:

Behavioral: use of standard technology

Behavioral: use of virtual reality