Non-immersive Virtual Reality for Pediatric Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- LLANTO Pain level: LLANTO pain scale
研究概览
简要总结
This is a multicenter, randomized, clinical trial comparing treatment as usual to distraction with video projection or virtual reality in the management of pediatric (3-6 years) pain associated with venipuncture, intramuscular injection, and vaccination.
详细描述
Background: Recent studies have shown that the use of virtual reality (VR) may be useful to provide distraction that attenuates pain in minimally invasive procedures in preschool children.
Aim: To assess the effectiveness of non-immersive virtual reality as a pain-distraction measure in children between the ages of 3 to 5 years undergoing painful injection procedures in an outpatient setting.
Method: This clinical trial will recruit patients under 6 years of age treated at participating medical centers in whom a painful procedure like vaccination, venipuncture or administration of intramuscular medication will be performed. The experimental group will consist of two subgroups which, in addition to treatment as usual, will be distracted using virtual reality content delivered through goggles. The control group will receive treatment as usual. The LLANTO pain scale will be used to measure different characteristics of pain. This scale has been validated in Colombia, and will be filled by two health professionals (one of which will perform the painful procedure.) and the parents.
Expected results: To show that virtual reality or projector distraction are effective distraction tools in pain management for children subjected to painful procedures of venipuncture, intramuscular medication administration, and vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients subjected to procedures of venipuncture, intramuscular injections, or vaccination at participating medical centers.
排除标准
- •Fever (Axillary temperature greater than 38°C).
- •Systemic Inflammatory Response Syndrome or Sepsis.
- •Pulmonary disease.
- •Neurological deficit of any kind.
- •Susspected or confirmed metabolic disease.
- •Undernutrition or obesity as defined by deviations from the mean of local values.
结局指标
主要结局
LLANTO Pain level: LLANTO pain scale
时间窗: Immediately after procedure
Overall pain assessment using the LLANTO pain scale (Mild: 0-3, Moderate 4-6, Intense 7-10) For more information about LLANTO scale, please visit DOI: 10.1016/j.anpedi.2010.08.005
次要结局
- LLANTO Attitude(Immediately after procedure)
- LLANTO Postural muscle tone(Immediately after procedure)
- Interrater reliability of the LLANTO scale(During the statistical analysis stage)
- LLANTO Crying(Immediately after procedure)
- LLANTO Breathing(Immediately after procedure)
- LLANTO Facial expression(Immediately after procedure)
研究者
Claudia Aristizábal
Coordinadora Unidad de Investigación
Sanitas University