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

NCT06993259 | Completed

• 1 other identifier: KOC_UNI
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety; Fear; Allergy

Outcome Measures

Primary Outcomes (3)

• Wong-Baker Facial Expression Rating Scale

  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.

  Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)

• Child Fear Scale

  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.

  Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)

• Child Anxiety State Scale

  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.

  Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)

Secondary Outcomes (1)

• VAS Care Satisfaction Score

  Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)

Study Arms (3)

Control Group

NO INTERVENTION

Serious Game

EXPERIMENTAL

Device: Serious game

Virtual Reality

EXPERIMENTAL

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

Children in the virtual reality (VR) group watched a 360° Ice Age video via headset starting three minutes before and continuing throughout the allergy test. The video, selected by pediatric experts, was age-appropriate, visually rich, and emotionally neutral. VR provided immersive distraction to reduce pain, fear, and anxiety. After the test, children and parents rated pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction through structured forms.

Virtual Reality

Serious game DEVICE

Children in the serious game group played Subway Surfers on a tablet starting three minutes before and continuing throughout the skin prick test. The game was chosen by pediatric experts for its age-appropriateness and ability to sustain attention without overstimulation. As a fast-paced, interactive tool, it served as an effective distraction to reduce pain, fear, and anxiety. After the procedure, children and parents rated pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction using structured feedback forms.

Serious Game

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Koç University

Istanbul, Istanbul, 34450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Hypersensitivity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This research was designed as a randomized controlled trial with a parallel-group structure (intervention-control) to examine the effects of serious gaming and virtual reality interventions on reducing pain, fear, and anxiety levels, as well as improving care satisfaction among children aged 6-12 years who underwent skin prick tests.

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 28, 2025
• Study Start: January 1, 2025
• Primary Completion: May 8, 2025
• Study Completion: May 15, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)