Food Allergy, Food Allergy in Children
Conditions
Keywords
food allergy, oral food challenge, virtual reality
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.
Interventions
BEHAVIORALuse 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.
BEHAVIORALuse 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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed