Use of Virtual Reality in Pain Management During Invasive Gestures in Pediatric Oncology: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Self pain evaluation
研究概览
简要总结
DOREVI is a monocentric randomized controlled study that will evaluate the efficacy of virtual reality helmets for pain prevention during invasive care on 78 oncologic pediatric patients. Two groups of children (between 6 and 11 and between 12 and 18 years old) will be randomized to use helmet plus standard care or standard care alone during invasive procedures (central venous catheter puncture, lumbar puncture, or bone marrow aspiration). The pain intensity will be evaluated using a visual analogic scale during three invasive procedures, and results will be compared between the patients with or without virtual reality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who tolerates the virtual reality headset
- •patient followed in pediatric oncology
- •patient with a diagnosis of benign tumor or cancer
- •patient who needs to have painful medical procedure during their treatment
- •patient whose parents have signed the informed consent
- •patient affiliated with social security or equivalent
排除标准
- •patient with visual or hearing impairement
- •patient with epilepsy or other neurological disease
- •patient with psychiatric disease
研究组 & 干预措施
Intervention
Patients randomized in this arm will have the virtual reality headset associated to the standard care
干预措施: Virtual reality headset (Other)
Standard care
patients randomized in this arm will have standard care.
结局指标
主要结局
Self pain evaluation
时间窗: before blood sampling on catheter with implantable chamber
Pain will be assessed by the analogic visual scale (minimal score = 0 (no pain) , maximal score = 10 (maximal pain))
次要结局
未报告次要终点