Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Mean Pain Score
研究概览
简要总结
Children with burn injuries experience severe pain intensity during medical procedures despite the increasing doses of analgesics. 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. Virtual reality (VR) has gained growing consideration as a non-pharmacological method as it engages multiple senses and allows interactions with a virtual world. Oculus Rift ® is a new technology in VR that provides more immersiveness, at a relatively low cost, and could probably improve the management of pain and anxiety in burn care. It also has the potential, with appropriate custom software designed for burn pediatric patients, to reduce the cybersickness symptoms (nausea, dizziness) associated with VR. To the knowledge of the investigators, none of the pediatric hospitals across Canada have tested VR as a method of pain and anxiety management in children with burn injuries. Overall hypotheses: VR distraction via Oculus Rift ® could be an effective method to relieve pain, and anxiety, as well as a less traumatizing hospital experience, while promoting a more humanistic care environment by combining new technologies (VR via Oculus Rift ®) to standard analgesic interventions administered to these children. The expected results will have a direct effect on physical (pain) and psychological (anxiety, pain memories) health of the child. In addition, clinical implications may include other indicators of quality of care and economic benefits such as a wider range of motion of burned limbs and reduction in dosage of opioids and anxiolytic drugs administered.
详细描述
- BACKGROUND:
Burn injuries are the leading cause of morbidity and mortality in children. They are associated with a lot of pain that is difficult to treat and can impede recovery, cause high levels of anxiety and alter future pain behaviors, resulting at times in chronic pain, paresthesia, or depression. Pain can also decrease participation in treatments such as physiotherapy resulting in poor health outcomes. Beyond the immediate pain experience, children may develop memories that are accurate, positively or negatively estimated (i.e., remembering more or less pain, respectively, as compared to initial pain reports). The way that children's memories are framed is important for future pain coping and distress at subsequent painful experiences. Moreover, it has been shown that pharmacological and non-pharmacological pain management strategies may buffer children from developing such biases in pain memories. Procedural pain is still largely managed pharmacologically mostly through the use of opioids, benzodiazepines and other pharmacological agents which cause a lot of side effects and do not always provide sufficient pain reduction. In recent years, the effectiveness of multimodal approaches combining medication with non-pharmacological interventions for procedural pain relief has been highlighted. Distraction techniques engaging multiple senses may grab the child's attention more than the techniques that only engage one sense (e.g, music), hence, the increasing interest in more immersive and interactive methods of distraction such as VR.
VR is an active distraction method that allows the user to interact with an immersive environment generated by a computer stimulating different senses. A review of studies on VR, mostly conducted with adult burn patients, showed a 35 to 50% reduction in procedural pain while using VR. However, despite promising results, the use of VR in healthcare settings has been limited, mainly due to its high cost. Reviews have highlighted the need for more research but mostly for the development of more portable, less expensive and more developed VR systems that would promote pain reduction during burn procedures especially for children with burn injuries who are considered one of the most challenging burn populations. However, there has been a breakthrough in technology since 2014 when big scale companies started investing in VR development for commercial gaming. Facebook purchased the Oculus Rift® for mass production allowing access to the latest technology in VR at a relatively low cost. Oculus Rift® is a VR tool that provides a wide field of view, high resolution display, integrated 3D audio and motion detection. In addition, its highly immersive properties could help achieve more analgesia compared to other VR techniques as a review has shown that the sense of presence influences the effectiveness of VR-based analgesia. The sense of presence is a subjective psychological state of consciousness of being in the virtual world whereas immersiveness refers to the physical environment that could be quantified by measuring the field of view or the peripheral vision in the VR goggles. The availability of inexpensive yet highly immersive VR googles such as Oculus Rift® could increase the use of VR in pain management and burn settings while significantly improving its cost effectiveness. A single case study assessed the feasibility of a VR intervention via Oculus Rift® in one child of 11 years old with burn injuries during occupational therapy. The study showed a reduction in pain intensity and pain unpleasantness experienced by the patient, without any side effects. To the knowledge of the investigators, no other studies have tested the distraction via Oculus Rift® for procedural pain management in children with burn injuries undergoing painful physiotherapy treatments. 2. AIM:
The aim of this study is to assess the effect of distraction by VR via Oculus Rift® for the relief of procedural pain, anxiety and decrease memory of pain in children with burn injuries.
Primary Research Question: In children aged 7 to 18 years, who have suffered burn injuries, does VR distraction via Oculus Rift® combined with analgesics provide better pain relief during painful procedures including dressing changes and physiotherapy than standard pharmacological treatment alone?
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
- 7 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suffer from a burn injury requiring wound dressing change or physiotherapy
- •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 dressing change or physiotherapy
- •suffer 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 the use of the Oculus Rift headset
研究组 & 干预措施
Standard pharmacological treatment
Standard pharmacological treatment (including Morphine) according to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and pain clinic nurse.
干预措施: Morphine (Drug)
VR distraction via Oculus Rift
In addition to standard pharmacological treatment, Virtual reality distraction through the use of Oculus Rift® will be used as the experimental intervention.
干预措施: VR distraction via Oculus Rift (Device)
结局指标
主要结局
Mean Pain Score
时间窗: T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)
Numerical Rating Scale (NRS) ranging from 0 to 10; 0=no pain to 10=pain as bad as it could be
次要结局
- Pain Experience(T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session))
- Expected Anxiety(Baseline (T1))
- Experienced Anxiety(T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session))
- Satisfaction Level(T4: 30 minutes after the procedure)
- Side Effects(T4: 30 minutes after the procedure)
- Comfort Level(T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session))
- Pain Memory(24 hours after the procedure (T5))
- Anxiety Memory(24 hours after the procedure (T5))
- Range Of Motion(Baseline (T1); T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session))
研究者
Sylvie Le May
Principal Investigator
St. Justine's Hospital
