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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04376242
Other study ID # 56108
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date September 30, 2025

Study information

Verified date June 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 information / eligibility

Status Recruiting
Enrollment 140
Est. completion date September 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group 5 Years to 17 Years
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: - 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

Study Design


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Children's Fear Scale Score Before and After OFC dosing 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. 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.
Primary Change in Childhood Anxiety Meter Score Before and After OFC dosing 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). Before and after each evaluation (approximately 4-6 hours between measurements at each visit, with visits approximately 1 week apart)
Secondary Level of Immersion after OFC Modified scale to assess cognitive absorption as a measure of immersion in the technology. After each evaluation (approximately 1 week apart)
Secondary Level of satisfaction - participant, caregiver and provider 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. After each evaluation (approximately 1 week apart)
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