Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge

Not Applicable

Recruiting

Interventions: Behavioral: use of virtual reality
Behavioral: use of standard technology

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
standard technology then virtual reality	use of 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
virtual reality then standard technology	use of virtual reality	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
virtual reality then standard technology	use of 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
standard technology then virtual reality	use of standard technology	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

Primary Outcome Measures

Name	Time	Method
Change in Children's Fear Scale Score Before and After OFC dosing	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.	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.
Change in Childhood Anxiety Meter Score Before and After OFC dosing	Before and after each evaluation (approximately 4-6 hours between measurements at each visit, with visits approximately 1 week apart)	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).

Secondary Outcome Measures

Name	Time	Method
Level of satisfaction - participant, caregiver and provider	After each evaluation (approximately 1 week apart)	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.
Level of Immersion after OFC	After each evaluation (approximately 1 week apart)	Modified scale to assess cognitive absorption as a measure of immersion in the technology.

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