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Completed

NCT Number: NCT06993259

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

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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Key information

Conditions

Pain Allergy Anxiety Anxiety Disorders Fear Hypersensitivity Immune System Diseases Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University

Istanbul, 34450, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Wong-Baker Facial Expression Rating Scale

    Time frame: 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.

  2. Child Fear Scale

    Time frame: 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.

  3. Child Anxiety State Scale

    Time frame: 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 outcomes

  1. VAS Care Satisfaction Score

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

Comparison of the Effectiveness of Virtual Reality and Serious Games on Pain, Fear, Anxiety, and Satisfaction During Skin Prick Testing in Children Aged 6-12 Years: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 28, 2025
Registry last updated
May 28, 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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