Feasibility and acceptability of perioperative application of biofeedback-based virtual reality versus active control for pain and anxiety in children and adolescents undergoing surgery: protocol for a pilot randomised controlled trial.
Feasibility and acceptability of perioperative application of biofeedback-based virtual reality versus active control for pain and anxiety in children and adolescents undergoing surgery: protocol for a pilot randomised controlled trial.
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DOI：
10.1136/bmjopen-2022-071274
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发表时间：
2023-01-25
期刊：
影响因子：
2.9
通讯作者：
Olbrecht VA
中科院分区：
文献类型：
--
作者：
Orgil Z;Johnson L;Karthic A;Williams SE;Ding L;Kashikar-Zuck S;King CD;Olbrecht VA
虚拟现实（VR）的当前临床应用通过重定向注意力为患者在急性疼痛事件期间提供短暂的疼痛缓解。生物反馈（BF）是一种身心疗法，可以有效地产生持续的疼痛减轻，但其常规使用存在障碍。结合起来，基于BF的VR（VR-BF）可以增加可访问性，同时增强BF的好处。VR-BF尚未用于围手术期护理，因此，不存在针对VR-BF的定义的治疗方案。本研究的主要目的是评估儿童和青少年围手术期使用VR-BF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。这是一项单中心、随机对照的初步临床试验。将总计70例计划接受手术的患者（12-18岁）随机分配至两个研究组之一（VR-BF或对照组），这些患者预计会导致中度至重度疼痛，住院时间≥1晚。随机分配至VR-BF组的参与者（n=35）将使用ForeVR VR平台在游戏化VR应用程序中进行呼吸。随机分配至对照组的参与者（n=35）将与疼痛反射应用程序“管理我的疼痛”进行互动。主要结局是VR-BF在接受手术的青少年中使用的可行性，通过招募、入组、保留和方案依从性进行评估。次要结局是VR-BF的可接受性和先导性疗效指标，包括疼痛、焦虑和阿片类药物消耗。该方案得到了全国儿童医院机构审查委员会（IRB #00002080）的批准。患者招募将于2023年3月开始。获得所有参与者的书面知情同意书。所有获得的信息将通过科学会议传播，并在同行评审的期刊上发表。将根据请求提供数据，结果将发布在ClinicalTrials.gov. ClinicalTrials.gov登记研究（NCT 04943874）上。
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. 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, Manage My Pain. 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. 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. ClinicalTrials.gov Registry (NCT04943874).
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影响因子：
1.7
作者：
Cravero, Joseph P.;Agarwal, Rita;Wilder, Robert
通讯作者：
Wilder, Robert
影响因子：
4.2
作者：
Chan, Engle Angela;Chung, Joanne W. Y.;Yang, Jiu Yung
通讯作者：
Yang, Jiu Yung
影响因子：
7.4
作者：
Hoffman, HG;Doctor, JN;Furness, TA
通讯作者：
Furness, TA
影响因子：
1.7
作者：
Groenewald, Cornelius B.;Rabbitts, Jennifer A.;Harrison, Tracy E.
通讯作者：
Harrison, Tracy E.
DOI：
10.1002/14651858.cd011118.pub2
发表时间：
2015-03-23
期刊：
The Cochrane database of systematic reviews
影响因子：
--
作者：
Fisher, Emma;Law, Emily;Eccleston, Christopher
通讯作者：
Eccleston, Christopher