Food Allergy in ChildrenNCT04376242
Virtual Reality Technology Versus Standard Technology During Pediatric Oral Food Challenge
A study testing use of virtual reality and use of standard technology in people with Food Allergy in Children and Food Allergy, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Food Allergy in Children, Food Allergy
- What is being tested?
- use of virtual reality and use of standard technology
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- People who do not consent
- Significant Cognitive Impairment
- History of Severe Motion Sickness
- Current Nausea
- Seizures
- Visual Problems
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- Non-English Speaking
- Patients who clinically unstable or requires urgent/emergent intervention
- ASA class 4 or higher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Utilization of Virtual Reality Technology Versus Standard of Care During Pediatric Oral Food Challenge: a Pilot Study
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.
- Conditions
- Food Allergy in Children, Food Allergy
- Being tested
- use of virtual reality, use of standard technology
- Keywords
- food allergy, oral food challenge, virtual reality
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of virtual realityBehavioural
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 technologyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality then standard technology | Experimental | 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 Receives: Behavioral: use of virtual reality; Behavioral: use of standard technology |
| standard technology then virtual reality | Active comparator | 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 Receives: Behavioral: use of virtual reality; Behavioral: use of standard technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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).
Measured: Before and after each evaluation (approximately 4-6 hours between measurements at each visit, with visits approximately 1 week apart)
Secondary outcomes (2)
Level of Immersion after OFC
Modified scale to assess cognitive absorption as a measure of immersion in the technology.
Measured: After each evaluation (approximately 1 week apart)
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.
Measured: After each evaluation (approximately 1 week apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Feb 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Why it stopped: Resources not available to continue study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayantani B. Sindher, Stanford University
- Investigators
- Sayantani Sindher, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376242
- Sponsor's protocol ID
- 56108
- Status last verified
- Jan 2025
- First submitted
- 29 Apr 2020
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of Virtual Reality Technology Versus Standard of Care During Pediatric Oral Food Challenge: a Pilot Study
- ClinicalTrials.gov ID
- NCT04376242
- Acronym / sponsor ID
- 56108
- Conditions
- Food Allergy in Children, Food Allergy
- Keywords
- food allergy, oral food challenge, virtual reality
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resources not available to continue study
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality then standard technology | Experimental | Behavioral: use of virtual reality, Behavioral: use of standard technologypatients 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 | Active comparator | Behavioral: use of virtual reality, Behavioral: use of standard technologypatients 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 |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- People who do not consent
- Significant Cognitive Impairment
- History of Severe Motion Sickness
- Current Nausea
- Seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of virtual realityThe intervention is a virtual reality program designed to immerse participants in a gaming experience to improve anxiety and fear during an oral food challenge. | Behavioural | standard technology then virtual reality, virtual reality then standard technology |
| use of standard technologythe 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. | Behavioural | standard technology then virtual reality, virtual reality then standard technology |
Primary outcome
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).
2 secondary outcomes
Level of Immersion after OFC
Time frame: After each evaluation (approximately 1 week apart)
Level of satisfaction - participant, caregiver and provider
Time frame: After each evaluation (approximately 1 week apart)
Results and safety
The study was stopped early (reason given: Resources not available to continue study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No. No plan to share.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayantani Sindher, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of virtual reality and use of standard technology in people with Food Allergy in Children and Food Allergy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Resources not available to continue study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.