Department of Clinical Research Services, Nationwide Children's Hospital, Columbus, Ohio, USA.
Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, Ohio, USA.
BMJ Open. 2023 Jan 25;13(1):e071274. doi: 10.1136/bmjopen-2022-071274.
INTRODUCTION: Current clinical applications of virtual reality (VR) provide patients with transient pain relief during acutely painful events by redirecting attention. Biofeedback (BF) is a mind-body therapy that effectively produces sustained pain reduction, but there are obstacles to its routine use. Combined, BF-based VR (VR-BF) may increase accessibility while enhancing the benefits of BF. VR-BF has yet to be employed in perioperative care, and as such, no defined treatment protocol for VR-BF exists. The primary aim of this study is to assess the feasibility of the perioperative use of VR-BF in children and adolescents. The secondary aims are to assess the acceptability of VR-BF and to collect pilot efficacy data. METHODS AND ANALYSIS: This is a single-centre, randomised controlled pilot clinical trial. A total of 70 patients (12-18 years) scheduled for surgery anticipated to cause moderate to severe pain with ≥1 night of hospital admission will be randomised to one of two study arms (VR-BF or control). Participants randomised to VR-BF (n=35) will use the ForeVR VR platform to engage their breathing in gamified VR applications. Participants randomised to control (n=35) will interact with a pain reflection app, . The primary outcome is feasibility of VR-BF use in adolescents undergoing surgery as assessed through recruitment, enrolment, retention and adherence to the protocol. Secondary outcomes are acceptability of VR-BF and pilot efficacy measures, including pain, anxiety and opioid consumption. ETHICS AND DISSEMINATION: The protocol was approved by the Nationwide Children's Hospital Institutional Review Board (IRB #STUDY00002080). Patient recruitment begins in March 2023. Written informed consent is obtained for all participants. All information acquired will be disseminated via scientific meetings and published in peer-reviewed journals. Data will be available per request and results will be posted on ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04943874).
简介:当前虚拟现实(VR)在临床上的应用通过转移注意力为患者提供了短暂的急性疼痛缓解。生物反馈(BF)是一种身心治疗方法,可有效减轻持续性疼痛,但在常规应用中存在障碍。将 BF 与 VR 相结合(VR-BF)可能会增加其可及性,同时增强 BF 的益处。VR-BF 尚未应用于围手术期护理,因此,目前尚无 VR-BF 的既定治疗方案。本研究的主要目的是评估 VR-BF 在儿童和青少年围手术期应用的可行性。次要目的是评估 VR-BF 的可接受性并收集初步疗效数据。
方法和分析:这是一项单中心、随机对照的初步临床试验。共有 70 名(12-18 岁)预计接受中等至重度疼痛手术且至少住院一晚的患者将被随机分为两个研究组(VR-BF 或对照组)。被随机分配到 VR-BF 组(n=35)的参与者将使用 ForeVR VR 平台在游戏化 VR 应用中进行呼吸训练。被随机分配到对照组(n=35)的参与者将与疼痛反射应用程序进行互动。主要结果是评估青少年接受手术时 VR-BF 使用的可行性,评估指标包括招募、入组、保留和遵守方案的情况。次要结果是 VR-BF 的可接受性和初步疗效指标,包括疼痛、焦虑和阿片类药物的使用。
伦理和传播:该方案已获得全美儿童医院机构审查委员会(IRB#STUDY00002080)的批准。患者招募于 2023 年 3 月开始。所有参与者均获得书面知情同意。所有获取的信息将通过科学会议进行传播,并发表在同行评议的期刊上。根据要求提供数据,结果将发布在 ClinicalTrials.gov 上。
试验注册号:ClinicalTrials.gov 注册表(NCT04943874)。
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