Usefulness of Virtual Reality in the Management of Pain Associated With Venipuncture in Pediatrics: a Multi-center Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 12
- 主要终点
- Anxiety
研究概览
简要总结
The goal of this clinical trial is to test if the use of virtual reality glasses reduces the pain and anxiety that children feel when they perform a blood test.
Children between 7 and 12 years old from 5 health centers and 2 hospitals will participate, and the children will be divided into two groups. In the control group, the analysis will be done in the usual way (for example, distracting with questions) and in the intervention group, the analysis will be done while the children use virtual reality.
The satisfaction of parents and nursing will also be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between 7 and 12 years old who attend participating centers for scheduled blood tests.
- •Consent to participate by signing the informed consent.
排除标准
- •Children younger than 7 years old.
- •Children older than 12 years old.
- •Children that don't sign the informed consent.
- •Children with psychomotor and neurocognitive delay.
- •Children with visual or hearing impairment.
结局指标
主要结局
Anxiety
时间窗: 1 day: The day of the venipuncture
Groningen distress scale: From 1 to 5. 1 implies a non-anxious patient and 5 a very anxious patient.
Pain associated with venipuncture
时间窗: 1 day: The day of the venipuncture
Visual analog scale: From 1 to 10. 1 implies minimal pain and 10 unbearable pain.
次要结局
- Time required for analysis(1 day: The day of the venipuncture)
- Difficulty level of the technique(1 day: The day of the venipuncture)
- Parents satisfaction(1 day: The day of the venipuncture)
- Number of attempts for analytics(1 day: The day of the venipuncture)
- Nurse anxiety(1 day: The day of the venipuncture)
研究者
Raquel Gil Piquer
Principal investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana