Effect of immersive virtual reality in decreasing the analgesic requirement during dressing change in children with burn injuries: A prospective, cross-over, randomized controlled study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the total incremental dose of Intravenous Fentanyl consumed during dressing change
研究概览
简要总结
This study is a cross over, randomized, controlled to study the effect of immersive virtual reality in decreasing the analgesic requirement during dressing change in children with burn injuries .The primary outcome measure will be the total incremental dose of Intravenous Fentanyl consumed during dressing change in children who receive Immersive virtual reality distraction therapy in addition to routine standard of care versus those who don’t. The secondary outcome measures include Wong Baker FACES Pain Scale, hemodynamic parameters, patient, patient and dresser satisfaction on Likert Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •5 years to 15 year old children with less than 50% total body surface area of burn injury that occurred within the past 5 days and need intravenous analgesia for pain management during dressing change.
排除标准
- •Patient is excluded if they have facial burns or if their visual acuity or development is low enough to hamper seeing and understanding the video played or if there is profound hearing loss or in case of parent or child refusal or if the fitting of headset is highly uncomfortable for the patient or if the patient has history of motion sickness or has undergone surgery for the burn injury since admission.
结局指标
主要结局
the total incremental dose of Intravenous Fentanyl consumed during dressing change
时间窗: at the end of the dressing change
次要结局
- Wong Baker FACES Pain Scale(Before, immediately after and 15 mins after completion of dressing)
- time to first incremental analgesic bolus requirement and number of boluses given(recorded every time a bolus dose of intravenous fentanyl is given)
- hemodynamic parameters like heart rate and oxygen saturation(from fifteen minutes before to fifteen minutes after the dressing at every five minute interval)
- Patient and Parental Satisfaction on Likert Scale(after completion of dressing)
- dresser satisfaction on the Likert Scale(after completion of the dressing)
- any adverse effect due to virtual reality distraction therapy(throughout the dressing)
研究者
Abirami S
All India Institute of Medical Sciences, New Delhi