Back to resultsVirtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge
Primary Purpose
Food Allergy in Children, Food Allergy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
use of virtual reality
use of standard technology
Sponsored by
About this trial
This is an interventional treatment trial for Food Allergy in Children focused on measuring food allergy, oral food challenge, virtual reality
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
- Seizures
- Visual Problems
- Non-English Speaking
- Patients who clinically unstable or requires urgent/emergent intervention
- ASA class 4 or higher
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
virtual reality then standard technology
standard technology then virtual reality
Arm 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
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
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Level of Immersion after OFC
Modified scale to assess cognitive absorption as a measure of immersion in the technology.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04376242
Brief Title
Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge
Official Title
The Utilization of Virtual Reality Technology Versus Standard of Care During Pediatric Oral Food Challenge: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy in Children, Food Allergy
Keywords
food allergy, oral food challenge, virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
virtual reality then standard technology
Arm Type
Experimental
Arm 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
Arm Title
standard technology then virtual reality
Arm Type
Active Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
use of virtual reality
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
use of standard technology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Children's Fear Scale Score Before and After OFC dosing
Description
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.
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.
Title
Change in Childhood Anxiety Meter Score Before and After OFC dosing
Description
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).
Time Frame
Before and after each evaluation (approximately 4-6 hours between measurements at each visit, with visits approximately 1 week apart)
Secondary Outcome Measure Information:
Title
Level of Immersion after OFC
Description
Modified scale to assess cognitive absorption as a measure of immersion in the technology.
Time Frame
After each evaluation (approximately 1 week apart)
Title
Level of satisfaction - participant, caregiver and provider
Description
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.
Time Frame
After each evaluation (approximately 1 week apart)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Seizures
Visual Problems
Non-English Speaking
Patients who clinically unstable or requires urgent/emergent intervention
ASA class 4 or higher
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayantani Sindher, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Team
Phone
650-521-7237
Email
snpcenterallergy_inquiry@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share.
Learn more about this trial
Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge
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