AllergyNCT06952192
Virtual Reality During Skin Prick Test
A study testing Virtual reality in people with Allergy, run by Federico II University at 1 site in Italy.
Trial summary
Skin prick testing (SPT) is a cornerstone diagnostic procedure for identifying allergic sensitizations in pediatric patients. Despite being minimally invasive, it often provokes considerable anxiety, fear, and pain, potentially compromising test accuracy due to poor compliance. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Allergy
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 1 Feb 2025
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- a confirmed history of allergic symptoms related to either environmental or food allergens
- between 4 and 18 years of age
Who cannot join
- history of seizure disorders,
- motion sickness,
- severe developmental delay,
- non-Italian-speaking patients
- Participants who had used systemic antihistamines or corticosteroids within the past seven days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Virtual Reality in Reducing Anxiety, Fear, and Pain in Pediatric Patients Undergoing Skin Prick Testing: A Cross-Over Study
Skin prick testing (SPT) is a cornerstone diagnostic procedure for identifying allergic sensitizations in pediatric patients. Despite being minimally invasive, it often provokes considerable anxiety, fear, and pain, potentially compromising test accuracy due to poor compliance. Virtual Reality (VR) has emerged as a promising non-pharmacological tool for procedural distress management, yet its application in allergy diagnostics remains underexplored.
To evaluate the effectiveness of VR in reducing procedural anxiety, fear, and pain, and in improving compliance in children undergoing SPT.
- Conditions
- Allergy
- Being tested
- Virtual reality
- Keywords
- virtual reality, skin prick test, pediatric allergy, anxiety, pain, compliance
- Medical subject headings
- Hypersensitivity, Anxiety Disorders, Pain, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
VR application via a head-mounted display one minute before and throughout the SPT procedure. The VR intervention utilized a Samsung Gear VR headset (Samsung, Seoul, South Korea) in conjunction with a Samsung S7 or S8 mobile device to provide an immersive and engaging experience. Children were allowed to choose from a range of age-appropriate VR content designed to enhance engagement and relaxation. Prior to the procedure, children were trained on how to use the headset by study staff to ensure a smooth experience.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Not described Receives: Device: Virtual reality |
| Standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of procedural anxiety in pediatric patients undergoing skin prick test
The primary objective of this study was to evaluate the effectiveness of VR in reducing procedural anxiety in pediatric patients undergoing SPT. Anxiety levels were assessed using the CAM scale before (0), during (1), post procedure, i.e., one minute after the procedure (2).
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Jan 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952192
- Sponsor's protocol ID
- 11n24
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality in Reducing Anxiety, Fear, and Pain in Pediatric Patients Undergoing Skin Prick Testing: A Cross-Over Study
- ClinicalTrials.gov ID
- NCT06952192
- Acronym / sponsor ID
- 11n24
- Conditions
- Allergy
- Keywords
- virtual reality, skin prick test, pediatric allergy, anxiety, pain, compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 30 Apr 2025 (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.
Skin prick testing (SPT) is a cornerstone diagnostic procedure for identifying allergic sensitizations in pediatric patients. Despite being minimally invasive, it often provokes considerable anxiety, fear, and pain, potentially compromising test accuracy due to poor compliance. Virtual Reality (VR) has emerged as a promising non-pharmacological tool for procedural distress management, yet its application in allergy diagnostics remains underexplored.
To evaluate the effectiveness of VR in reducing procedural anxiety, fear, and pain, and in improving compliance in children undergoing SPT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual reality |
| Standard of care | No intervention | – |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- a confirmed history of allergic symptoms related to either environmental or food allergens
- between 4 and 18 years of age
Key exclusion criteria (5 listed)
- history of seizure disorders,
- motion sickness,
- severe developmental delay,
- non-Italian-speaking patients
- Participants who had used systemic antihistamines or corticosteroids within the past seven days
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 |
|---|---|---|
| Virtual realityVR application via a head-mounted display one minute before and throughout the SPT procedure. The VR intervention utilized a Samsung Gear VR headset (Samsung, Seoul, South Korea) in conjunction with a Samsung S7 or S8 mobile device to provide an immersive and engaging experience. Children were allowed to choose from a range of age-appropriate VR content designed to enhance engagement and relaxation. Prior to the procedure, children were trained on how to use the headset by study staff to ensure a smooth experience. | Device | Virtual reality |
Primary outcome
change of procedural anxiety in pediatric patients undergoing skin prick test
Time frame: during the procedure
The primary objective of this study was to evaluate the effectiveness of VR in reducing procedural anxiety in pediatric patients undergoing SPT. Anxiety levels were assessed using the CAM scale before (0), during (1), post procedure, i.e., one minute after the procedure (2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Allergy, run by Federico II University at 1 site in Italy.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 30 Apr 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of procedural anxiety in pediatric patients undergoing skin prick test (time frame: during the procedure). 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 30 Apr 2025.