The Impact of Virtual Reality and Kaleidoscope Usage on Pain, Fear, and Anxiety in Children During Routine Vaccination: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Procedural Pain
研究概览
简要总结
This study was designed to examine the effects of using virtual reality and kaleidoscope during routine vaccination in children aged 48 months on pain, fear, and anxiety. Children aged 48 months who were to receive the measles-mumps-rubella vaccine were randomized into three groups. Accordingly, the study sample consisted of a virtual reality group with 42 children, a kaleidoscope group with 42 children, and a control group with 42 children, totaling 126 children. Fear and pain were evaluated by both the researcher and the child before and after the procedure. Anxiety was assessed by the child after the procedure. The Wong Baker Faces Pain Rating Scale was used for pain, the Children's Fear Scale for fear, and the Child Anxiety Scale-State Version for anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 48 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being 48 months
- •being conscious (with the ability to communicate).
排除标准
- •Having a physical and psychological condition that prevents them from wearing glasses to view VR;
- •Having a visual problem
- •Having mental or physical disabilities
- •Taking any analgesics, sedatives, or anticonvulsants in the past 24 hours
- •Having chronic or life-threatening disease
- •Refusing the VR or kaleidoscope intervention during vaccine injection.
结局指标
主要结局
Procedural Pain
时间窗: 1 year
Just before vaccination, both the child and the researcher used the Wong-Baker Faces Scale. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/no pain) to crying (10 = hurts worst). The child can choose the face that best illustrates the physical pain.
Fear
时间窗: 1 year
Just before vaccination, both the child and the researcher used the Children's Fear Scale. The scale includes five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) and has been validated for the Turkish population The scale allows for evaluations on a scale from 0 to 4.
Anxiety
时间窗: 1 year
Just before vaccination, both the child and the researcher used the Children's Anxiety Meter-State. It is drawn like a thermometer with a bulb at the bottom. It includes horizontal lines going up to the top (0-10). Children are asked to mark how feel "right now" to measure state anxiety. Higher values represent higher anxiety.
次要结局
- Parental satisfaction(1 year)
研究者
Merve Gümüş
Research Assistant Dr.
Ege University