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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Wong-Baker Facial Expression Rating Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Control Group
Serious Game
干预措施: Serious game (Device)
Virtual Reality
干预措施: Virtual Reality (Device)
结局指标
主要结局
Wong-Baker Facial Expression Rating Scale
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- VAS Care Satisfaction Score(Immediately after the skin prick test procedure (within 1-2 minutes post-intervention))
研究者
Remziye Semerci
Principal Investigator
Koç University