Virtual Reality Distraction for Procedural Pain Management in Children With Burn Injuries: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Mean Pain Score
研究概览
简要总结
Procedural pain is the most intense and often undertreated pain associated with burn injuries. The use of analgesics does not always provide optimal relief and is accompanied by several side effects. Indeed, children with burn injuries still experience severe pain intensity during procedures despite the fact that doses of analgesics used with this population has almost doubled in the last twenty years. Current guidelines on pediatric procedural pain management recommend the combination of non-pharmacological and pharmacological interventions to enhance pain management and decrease the numerous side effects of analgesics. Distraction has been identified among the most effective non-pharmacological interventions for pain as it diverts the child's attention to an attractive element, hindering the perception of the painful stimuli. Virtual reality is a method of active distraction that offers the child a multi-sensory immersive interaction that found many applications for pain management in adult patients. However, very few studies have tested the efficacy of distraction by virtual reality on procedural pain and anxiety in children with burn injuries.
This RCT follows a pilot study (NCT02794103) aimed at assessing the feasibility of a virtual reality prototype developed specifically for the hydrotherapy room of children under seven years old for the relief of procedural pain in children with burn injuries. The aim of the RCT will be to evaluate the effectiveness of the virtual reality prototype in relieving procedural pain in children from 6 months to 7 years old undergoing hydrotherapy session for burn injuries.
详细描述
BACKGROUND:
Preliminary data from the pilot study showed that the virtual reality prototype installed around the tank in the hydrotherapy room is a feasible and acceptable method of distraction that doesn't interfere with the work of healthcare professionals and could be used as a non-pharmacological method for pain management. A clinical trial is needed to assess the effectiveness of this intervention for procedural pain relief. The pilot study was also informative about the feasibility of the study design and the measurement used. The methods section was modified and adapted consequently for the upcoming trial.
METHODS:
Design: Within-subject/crossover study design. Each child will serve as their own control and will receive both standard and experimental treatment during the same hydrotherapy session through a randomized order.
Sample and Setting: Convenience sampling on the surgical-trauma burn unit at CHU Ste-Justine, of children admitted to the unit or to the day hospital for a burn injury. The intervention will take place in the hydrotherapy room of the CHU Ste-Justine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suffer from a burn injury requiring a hydrotherapy session
- •presence of a consenting parent who can understand, read and write either French or English
排除标准
- •Requiring intensive care
- •Having a diagnosed cognitive impairment
- •Are unconscious or intubated during the hydrotherapy sessions
- •Suffering from epilepsy (considering the nature of the intervention)
- •Allergic to opioids or other analgesics used for standard pharmacological treatment
- •Having burn injuries on the face preventing them from looking at the VR screen
- •Will be excluded in posteriori from analysis children sedated for more than 50% of the time during one or both study sequences (score of 3 or 4 on the University of Michigan Sedation Scale).
研究组 & 干预措施
Standard pharmacological treatment
干预措施: Standard Pharmacological Treatment (Other)
Virtual Reality distraction
干预措施: Virtual Reality Prototype (Device)
结局指标
主要结局
Mean Pain Score
时间窗: T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
French version of the Face, Legs, Activity, Cry and Consolability (FLACC)
次要结局
- Comfort(T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session))
- Sedation(T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session))
- Mean Pain Score - Observational/Behavioral Complementary measure(T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session))
- Analgesic requirement(T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session))
- Health professionals' satisfaction level(T4: immediately after the procedure before leaving the hydrotherapy room)
研究者
Sylvie Le May
RN, PhD, Professor, Université de Montréal
St. Justine's Hospital