Distraction in the Emergency Using Virtual Reality for Intravenous Needs in Children to Improve Comfort (DEVINCI): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Self-reported pain during the procedure: Verbal Numerical Rating Scale (VNRS)
研究概览
简要总结
Venipuncture is a frequently performed painful and anxiogenic procedure in the paediatric emergency department (PED). Topical anesthetic creams are used to reduce pain, but additional modalities can modulate the nociceptive experience and distress associated with venipuncture. Distraction can improve a patient's experience by mitigating their ability to focus on the painful sensory input. Through its immersive nature, virtual reality (VR) has the potential to distract patients from a 'real world' negative experience such as venipuncture. Given the potential for short- and long-term consequences of poorly controlled pain and distress in children, healthcare professionals must optimize patient comfort during medically required procedures. The aim of this pilot pragmatic RCT study is to determine the feasibility, acceptability and preliminary effect of a VR device (head-mounted Oculus Rift® (OR)) for pain and distress reduction associated with venipuncture in the PED.
详细描述
INTRODUCTION Pain management of venipuncture in the Paediatric Emergency Department (PED)
Inadequate pain management in paediatrics is known to have significant short and long-term consequences, such as negative memories, and greater pain perception during future procedures. This can in turn lead to chronic healthcare avoidance, with potential implications for increased morbidity. Suboptimal comfort plan is still consistently reported in the literature Venipuncture is a frequently performed painful and anxiogenic procedure in the paediatric emergency department (PED). It is among the most important causes of pain in paediatric wards. This can be distressing for children, parents and healthcare workers (HCW). Indeed, venipuncture is the leading cause of pain among hospitalized children. Up to 51% of pre-adolescents reported high levels of distress associated with this procedure. Many children reported moderate to severe procedural pain during their hospitalization according to recent studies. Moreover, physiologic evidence of distress has been reported in caregivers as they witness ED-based venipuncture in their child. Improved pain and distress management during venipuncture can also significantly decrease distress in ED nurses performing the procedure. It is therefore imperative to minimize the pain and distress associated with venipuncture, especially in a stressful environment such as the PED. Therefore, multimodal approaches are proposed, with combined strategies such as the four essential components by Friedrichsdorf, which include the use of topical anaesthetics, sucrose in neonate, comfortable positioning and distraction.
Pharmacological intervention: Topical anesthetics To reduce the discomfort generated by a venipuncture, the use of a topical anaesthetic cream is recommended prior to needle procedures, with options including EMLA ®, amethocaine and lidocaine. These products have shown favourable results when the cream is applied prior to venipuncture and IV cannulation. In the department, this strategy was introduced in 2013 and is available through a collective order for nurses to use. The cream can be applied by a triage nurse suspecting that the child will require venipuncture, or by the physician whose management plan includes a needle puncture. Unfortunately, despite no real disadvantage to its application, this is a strategy often forgotten by the treating team. At the study institution, the investigators use Maxilene®. Its application is shorter than EMLA, only requiring a 30 minute wait, which is often less than the time lapse, in the study PED, between the prescription of a venipuncture and the actual intervention. Moreover, the anesthetic cream has been proven to improve procedure success on first attempt and to shorten procedure time, compared to placebo. Despite these advantages, this strategy remains scarcely used as mentioned above.
Physical intervention: Comfort Position Due to their developmental characteristics, it is often difficult for children to rationally understand the indication for venipuncture. Immobilization is therefore used in many instances - up to 74% of the time according to a previous report - for intravenous (IV) placement or blood procuration. However, child restrain should be avoided as much as possible. Despite the use of topical anesthetics, venipuncture remains a traumatic experience for many children who are restrained. For this reason, a sitting position is encouraged in the literature to increase the comfort of paediatric patients during venipuncture.
Psychological intervention: Distraction Given the significant distress associated with venipuncture despite improvement with the use of topical anesthetics and positioning, other psychological adjuncts to pain management are important components of pain and distress management related to needle procedures. Psychological interventions are recognized strategies for pain and distress management in this setting, given their simplicity, practicality, and at a relatively low cost. Side effects are usually absent to minimal. Distraction is one such modality, based on the gate control theory, which improves a patient's experience by mitigating their ability to focus on the painful sensory input. Modalities such as the hide and find games ''I spy'', video games, bubbles, cartoons, ''stress balls'', and other sensory modalities have been used as adjuncts to pain management during venipuncture in children. The choice of modality depends on the setting and on the child's developmental age. Effective distraction techniques focus on children empowerment through attention to their preferences, using either active (eg. electronic games, ''I spy'' games) or passive (eg. music, video on television or tablet) distraction. In the study department, distraction strategies have been improved in the recent years by the Equipe Analgésie Urgence (EAU) team creating giant hide and find games in the procedure rooms and introducing electronic tablets for use during procedures. Further, members of the study team also studied other interventions done to distract children during painful procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prescription of a venipuncture (IV line placement or diagnostic venipuncture) by an attending physician
排除标准
- •Unstable patient or urgent procedure required
- •Cognitive impairment that would render interaction with the VR game and/or answer to the study questionaires unfeasable.
- •Diagnosis of epilepsy or any other condition precluding use of VR technology.
- •A parent is unavailable to provide consent for participation in the study.
研究组 & 干预措施
Virtual Reality Group
Patients in this group will be offered virtual reality distraction through the use of OR in addition to standard of care.
干预措施: Virtual Reality goggle (Oculus Rift ® Helmet) (Behavioral)
Standard of care group
Patients in this group will receive standard care, including the proposition to use topical anesthetic cream prior to venipuncture attempt, usual distraction and positioning proposed by the treating nurse.
结局指标
主要结局
Self-reported pain during the procedure: Verbal Numerical Rating Scale (VNRS)
时间窗: This outcome will be measured within 2 minutes of the end of the procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used) by asking the child to rate their level of pain during the procedure.
The primary outcome of this study is the mean pain score felt during the procedure (self-report of pain level during the procedure) measured by the Verbal Numerical Rating Scale (VNRS). The VNRS consists of pain scale from 0 (no pain) to 10 (extreme pain). It is a well-established, valid, and reliable tool for the self-report of pain intensity in children as young as 6 years of age. This scale is widely used as it requires a lower degree of abstraction and less resources when compared to the Visual Analog Scale (VAS). The VNRS requires no physical tools, which explains its wide use in older children and adults with acute pain.
次要结局
- Hetero-evaluation (by research nurse) of procedure-related distress(Measured during the procedure (period between the start of physical restraint or needle/catheter insertion until needle/catheter removal from vein and end of physical restraint in patients where it was used))
- Baseline pain score: Verbal Numerical Rating Scale (VNRS)(Measured following recruitment and at most 10 minutes before the start of the procedure (before the start of physical restraint or needle/catheter insertion))
- Auto-evaluation of post procedure-related distress(Measured within 5 minutes following the end of the procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used))
- Auto-evaluation of baseline procedure-related distress(Measured following recruitment and at most 10 minutes before the start of the procedure (before the start of physical restraint or needle/catheter insertion))
- Evaluation of overall pain management during venipuncture, with respect to pain relief, side effects, physical recovery, and emotional recovery.(Measured within 5 minutes following the end procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used))
研究者
Esli Osmanlliu
Fellow, Pediatric Emergency Medicine
St. Justine's Hospital
