Effectiveness of Virtual Reality in Reducing Anxiety, Fear, and Pain in Pediatric Patients Undergoing Skin Prick Testing: A Cross-Over Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- change of procedural anxiety in pediatric patients undergoing skin prick test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Virtual reality
Intervention: Virtual reality (Device)
Standard of care
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Roberto Berni Canani, MD, PhD
Full Professor
Federico II University