The Utilization of Virtual Reality Technology Versus Standard of Care During Pediatric Oral Food Challenge: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Food Allergy in Children
- Sponsor
- Stanford University
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Change in Children's Fear Scale Score Before and After OFC dosing
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Sayantani B. Sindher
Clinical Associate Professor
Stanford University
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
- •Visual Problems
- •Non-English Speaking
- •Patients who clinically unstable or requires urgent/emergent intervention
- •ASA class 4 or higher
Outcomes
Primary Outcomes
Change in Children's Fear Scale Score Before and After OFC dosing
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.
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
Time Frame: 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 Outcomes
- Level of satisfaction - participant, caregiver and provider(After each evaluation (approximately 1 week apart))
- Level of Immersion after OFC(After each evaluation (approximately 1 week apart))