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首页> 外文期刊>Trials >Virtual restorative environment therapy as an adjunct to pain control during burn dressing changes: study protocol for a randomised controlled trial
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Virtual restorative environment therapy as an adjunct to pain control during burn dressing changes: study protocol for a randomised controlled trial

机译：虚拟修复性环境疗法可作为烧伤敷料更改期间疼痛控制的辅助手段：一项随机对照试验的研究方案

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Background The pain of a severe burn injury is often characterised by intense background pain, coupled with severe exacerbations associated with essential procedures such as dressing changes. The experience of pain is affected by patients’ psychological state and can be enhanced by the anxiety, fear and distress caused by environmental and visual inputs. Virtual Reality (VR) distraction has been used with success in areas such as burns, paediatrics and oncology. The underlying principle of VR is that attention is diverted from the painful stimulus by the use of engaging, dynamic 3D visual content and associated auditory stimuli. Functional magnetic resonance imaging (fMRI) studies undertaken during VR distraction from experimental pain have demonstrated enhancement of the descending cortical pain-control system. Methods/Design The present study will evaluate the feasibility of introducing a novel VR system to the Burns Unit at the Queen Elizabeth Hospital Birmingham for dressing changes: virtual restorative environment therapy (VRET). The study will also explore the system’s impact on pain during and after the dressing changes compared to conventional analgesia for ward-based burn dressing changes. A within-subject crossover design will be used to compare the following three conditions: 1. Interactive VRET plus conventional analgesics. 2. Passive VRET with conventional analgesics. 3. Conventional analgesics alone. Using the Monte Carlo method, and on the basis of previous local audit data, a sample size of 25 will detect a clinically significant 33 % reduction in worst pain scores experienced during dressing changes. Discussion The study accrual rate is currently slower than predicted by previous audits of admission data. A review of the screening log has found that recruitment has been limited by the nature of burn care, the ability of burn inpatients to provide informed consent and the ability of patients to use the VR equipment. Prior to the introduction of novel interactive technologies for patient use, the characteristics and capabilities of the target population needs to be evaluated, to ensure that the interface devices and simulations are usable. Trial registration Current Controlled Trials ISRCTN23330756 . Date of Registration 25 February 2014.
机译：背景严重烧伤的疼痛通常以剧烈的背景疼痛为特征，并伴有诸如换药等基本程序的严重加重。疼痛的经历受患者的心理状态影响，而环境和视觉输入引起的焦虑，恐惧和困扰会加剧疼痛的经历。虚拟现实（VR）分散注意力已成功应用于烧伤，儿科和肿瘤学等领域。 VR的基本原理是，通过使用引人入胜的动态3D视觉内容和相关的听觉刺激，将注意力从痛苦的刺激中转移出来。在从实验性疼痛转移VR的过程中进行的功能磁共振成像（fMRI）研究表明，下行皮层疼痛控制系统得到了增强。方法/设计本研究将评估在伯明翰伊丽莎白女王医院Burns病房引入新型VR系统进行换药的可行性：虚拟恢复性环境治疗（VRET）。这项研究还将探讨该系统对换药期间和换药后疼痛的影响，与基于病房的烧伤换药的常规镇痛相比。受试者内部交叉设计将用于比较以下三个条件：1.交互式VRET加常规镇痛药。 2.被动VRET常规止痛药。 3.仅常规镇痛药。使用蒙特卡洛方法，并根据先前的本地审核数据，样本数量为25，将检测出换药期间发生的最坏疼痛评分在临床上明显降低了33％。讨论目前，研究应计率低于先前对入学数据进行审核的预期。审查日志的审查发现，招募受到烧伤护理的性质，烧伤住院患者提供知情同意的能力以及患者使用VR设备的能力的限制。在引入新颖的交互式技术供患者使用之前，需要评估目标人群的特征和能力，以确保接口设备和模拟可用。试用注册电流控制试验ISRCTN23330756。注册日期2014年2月25日。

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