Effects of an immersive virtual reality Intervention on pain and anxiety during venipuncture in children aged 7-12 years-a three arm concurrent parallel design randomized control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the mean differences in child, parent and clinician-reported pain scores as measured by Faces Pain Scale-Revised scale and Visual Analogue scale amongst Immersive Virtual Reality, tablet video, and standard procedure group during venipuncture.
研究概览
简要总结
The main objective of the trial is to know the effects of a virtual reality intervention on pain during venipuncture in children aged 7-12 years, as compared to the tablet video and standard procedure. Children aged 7-12 years admitted to the Pediatric ward will be recruited after informed parental consent and verbal assent. They will be randomly allocated to three groups. In Immersive VR group, the child will be wearing a VR game headset during venipuncture procedure during which time, child will be distracted by playing a game during the Venipuncture. In Tablet video group, child will be watching a cartoon video appropriate for their age during the Venipuncture. In Standard procedure group, child we be given verbal reassurance during venipuncture. In all 3 groups, the child, parent, and clinician reported pain will be assessed using the FACES pain scale at 2 timepoints(before and after venipuncture)
In all the three groups, Heart rate of the child will be monitored during venipuncture. Also, the level of immersion in VR device will be assessed using the GRIP Inventory. The data will be entered and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 7.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •All children admitted to the Pediatric ward aged 7-12 years in whom venipuncture is planned electively
- •Child should have a Glasgow Coma Scale of 15/15.
排除标准
- •Children with pre-existing photosensitive epilepsy, vertigo, migraine.
- •Children with moderate or severe intellectual disability, and developmental delay.
- •Child with previous history of syncope/vertigo during adventure games.
结局指标
主要结局
To compare the mean differences in child, parent and clinician-reported pain scores as measured by Faces Pain Scale-Revised scale and Visual Analogue scale amongst Immersive Virtual Reality, tablet video, and standard procedure group during venipuncture.
时间窗: T1 is 10 moinutes prior
次要结局
- To determine the child reported level of immersion of VR in the Immersive Virtual Reality group using the Gold Rizzo Immersion and Presence (GRIP) inventory.(30 mins)
研究者
Vangeti Rohitha Reddy
Mahatma Gandhi Medical College and Research Institute