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OpenTrials
Completed

NCT Number: NCT06952192

Virtual Reality During Skin Prick Test

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.

Completed

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Naples Federico II

Naples, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Effectiveness of Virtual Reality in Reducing Anxiety, Fear, and Pain in Pediatric Patients Undergoing Skin Prick Testing: A Cross-Over Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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