An interventional study of Virtual Reality and Serious game in Pain, Anxiety and Fear, sponsored by Trakya University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Trakya University · Not applicable, Interventional, and Prevention
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.
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This study's enrollment of 90 is above the median of 70 across 2,101 interventional studies indexed under Pain.
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Exclusion Criteria:
Device: Serious game
Device: Virtual Reality
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
VAS Care Satisfaction Score
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."
Time frame: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
Plan to share: No — Individual participant data (IPD) will not be shared due to privacy concerns and the lack of participant consent for data sharing beyond the scope of this study.
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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