Effect of Virtual Reality and Serious Games on Pain, Fear, Anxiety, and Satisfaction During Skin Prick Testing in Children

Not Applicable

Completed

• Conditions: Pain; Anxiety; Fear; Allergy

• Registration Number: NCT06993259
• Lead Sponsor: Trakya University

Brief Summary

This randomized controlled trial evaluated the effectiveness of virtual reality (VR) and serious gaming (SG) in reducing pain, fear, and anxiety, and improving satisfaction during skin prick testing (SPT) in children aged 6-12 years. A total of 90 children were randomly assigned to three groups: standard care (control), VR, or SG. The VR group watched a 360° animated video using a headset, while the SG group played Subway Surfers on a tablet. Pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction (VAS) were measured post-procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-05
• Primary Completion: 2025-05-08
• Study Completion: 2025-05-15
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Children aged 6 to 12 years
• Scheduled to undergo an allergy skin prick test
• No visual impairments
• No use of anxiolytic or analgesic medication within the past six hours
• Voluntary agreement to participate (child assent and parental consent)

Exclusion Criteria

• Not within the 6-12 age range
• Not scheduled for an allergy skin prick test
• Presence of visual impairments
• Use of anxiolytic or analgesic medication within the past six hours
• Refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wong-Baker Facial Expression Rating Scale	Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)	The Wong-Baker FACES scale includes six facial expressions scored from 0 ("No Pain") to 10 ("Worst Pain"). Children select the face that best represents their pain. Valid for ages 3-18, it is widely used for its simplicity and strong psychometric properties and has been translated into many languages, including Turkish.
Child Fear Scale	Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)	The Child Fear Scale consists of six facial expressions scored from 0 (no fear) to 10 (highest fear) in increments of two. Fear increases progressively across the faces. Its validity and reliability were confirmed by Avşan et al. (2024), and it aligns with pain scales in format and scoring.
Child Anxiety State Scale	Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)	The Child Anxiety State Scale (CAS-S), developed by Ersig et al. (2013), was validated in Turkish by Özalp Gerçeker et al. (2019). Designed for children aged 4-10, it resembles a thermometer and measures current anxiety ("right now"). The scale has strong psychometric properties and is suitable for clinical use.

Secondary Outcome Measures

Name	Time	Method
VAS Care Satisfaction Score	Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)	The Visual Analog Scale (VAS) for care satisfaction was used to evaluate children's satisfaction with the care received during the allergy testing procedure. Children were asked to indicate their level of satisfaction on a scale ranging from "0 - Not satisfied at all" to "10 - Very satisfied."

Trial Locations

Locations (1)

Koç University; 🇹🇷 Istanbul, Turkey