Virtual Reality During Skin Prick Test

NCT06952192 | Completed

• 1 other identifier: 11n24
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

virtual reality; skin prick test; pediatric allergy; anxiety; pain; compliance

Outcome Measures

Primary Outcomes (1)

• 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).

  during the procedure

Study Arms (2)

Virtual reality

EXPERIMENTAL

Device: Virtual reality

Standard of care

NO INTERVENTION

Interventions

Virtual reality DEVICE

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.

Virtual reality

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• a confirmed history of allergic symptoms related to either environmental or food allergens
• between 4 and 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Univeristy of Naples Federico II

Naples, Italy

Location

MeSH Terms

Conditions

Hypersensitivity; Anxiety Disorders; Pain; Patient Compliance

Condition Hierarchy (Ancestors)

Immune System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: January 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)