Eijlers Robin, Legerstee Jeroen S, Dierckx Bram, Staals Lonneke M, Berghmans Johan, van der Schroeff Marc P, Wijnen Rene Mh, Utens Elisabeth Mwj
Department of Child and Adolescent Psychiatry/Psychology, Erasmus University Medical Center (Erasmus MC) Sophia Children's Hospital, Rotterdam, Netherlands.
Department of Anesthesiology, Erasmus University Medical Center (Erasmus MC) Sophia Children's Hospital, Rotterdam, Netherlands.
JMIR Res Protoc. 2017 Sep 11;6(9):e174. doi: 10.2196/resprot.7617.
Preoperative anxiety in children is highly prevalent and is associated with adverse outcomes. Existing psychosocial interventions to reduce preoperative anxiety are often aimed at distraction and are of limited efficacy. Gradual exposure is a far more effective way to reduce anxiety. Virtual reality (VR) provides a unique opportunity to gradually expose children to all aspects of the operating theater.
The aims of our study are (1) to develop a virtual reality exposure (VRE) tool to prepare children psychologically for surgery; and (2) to examine the efficacy of the VRE tool in a randomized controlled trial (RCT), in which VRE will be compared to care as usual (CAU).
The VRE tool is highly realistic and resembles the operating room environment accurately. With this tool, children will not only be able to explore the operating room environment, but also get accustomed to general anesthesia procedures. The PREoperative Virtual reality Intervention to Enhance Wellbeing (PREVIEW) study will be conducted. In this single-blinded RCT, 200 consecutive patients (aged 4 to 12 years) undergoing elective day care surgery for dental, oral, or ear-nose-throat problems, will be randomly allocated to the preoperative VRE intervention or CAU. The primary outcome is change in child state anxiety level between baseline and induction of anesthesia. Secondary outcome measures include child's postoperative anxiety, emergence delirium, postoperative pain, use of analgesics, health care use, and pre- and postoperative parental anxiety.
The VRE tool has been developed. Participant recruitment began March 2017 and is expected to be completed by September 2018.
To our knowledge, this is the first RCT evaluating the effect of a VRE tool to prepare children for surgery. The VRE intervention is expected to significantly diminish preoperative anxiety, postoperative pain, and the use of postoperative analgesics in pediatric patients. The tool could create a less stressful experience for both children and their parents, in line with the modern emphasis on patient- and family-centered care.
Netherlands Trial Registry: NTR6116; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6116 (Archived by WebCite at http://www.webcitation.org/6ryke7aep).
儿童术前焦虑非常普遍，且与不良后果相关。现有的减轻术前焦虑的心理社会干预措施通常旨在分散注意力，效果有限。逐步暴露是减轻焦虑的一种更为有效的方法。虚拟现实（VR）为让儿童逐步接触手术室的各个方面提供了独特的机会。
我们研究的目的是（1）开发一种虚拟现实暴露（VRE）工具，让儿童在心理上为手术做好准备；（2）在一项随机对照试验（RCT）中检验VRE工具的效果，在该试验中，将VRE与常规护理（CAU）进行比较。
VRE工具高度逼真，准确模拟手术室环境。借助该工具，儿童不仅能够探索手术室环境，还能习惯全身麻醉程序。将开展术前虚拟现实干预以促进健康（PREVIEW）研究。在这项单盲RCT中，200名连续的患者（年龄4至12岁）因牙科、口腔或耳鼻喉问题接受择期日间手术，将被随机分配到术前VRE干预组或CAU组。主要结局是从基线到麻醉诱导期间儿童状态焦虑水平的变化。次要结局指标包括儿童术后焦虑、苏醒期谵妄、术后疼痛、镇痛药使用情况、医疗保健利用情况以及术前和术后父母焦虑。
VRE工具已开发完成。参与者招募于2017年3月开始，预计2018年9月完成。
据我们所知，这是第一项评估VRE工具让儿童为手术做好准备效果的RCT研究。预计VRE干预将显著减轻儿科患者术前焦虑、术后疼痛以及术后镇痛药的使用。该工具可为儿童及其父母创造压力较小的体验，符合现代对以患者和家庭为中心的护理的重视。
荷兰试验注册库：NTR6116；http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6116（由WebCite存档于http://www.webcitation.org/6ryke7aep）
