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虚拟现实干预降低择期手术成人术前焦虑的随机临床试验。

Virtual Reality-Based Intervention to Reduce Preoperative Anxiety in Adults Undergoing Elective Surgery: A Randomized Clinical Trial.

机构信息

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.

Department of Pharmacy, Singapore General Hospital, Singapore.

出版信息

JAMA Netw Open. 2023 Oct 2;6(10):e2340588. doi: 10.1001/jamanetworkopen.2023.40588.


DOI:10.1001/jamanetworkopen.2023.40588
PMID:37906193
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10618840/
Abstract

IMPORTANCE: Preoperative anxiety is common among adult patients undergoing elective surgery and is associated with negative outcomes. Virtual reality (VR)-based interventions have been considered simpler, safer, and more effective for reducing anxiety in patients undergoing surgery than conventional care. OBJECTIVE: To examine the effectiveness of a VR-based intervention with preoperative education in reducing preoperative anxiety among adult patients undergoing elective surgery. DESIGN, SETTING, AND PARTICIPANTS: An assessor-blinded prospective randomized clinical trial was conducted to recruit adult patients aged 18 years or older who were scheduled for their first elective surgery procedure under general anesthesia within the next 2 to 4 weeks at a preanesthesia assessment clinic in Hong Kong from July to December 2022. INTERVENTIONS: Participants were randomly assigned to either an intervention group (an 8-minute immersive 360° VR video tour in the operating theater via a head-mounted display console) or a control group (standard care). MAIN OUTCOMES AND MEASURES: The primary outcome of preoperative anxiety was measured using the Amsterdam Preoperative Anxiety and Information Scale (range, 6-30; higher scores indicate greater anxiety), and the secondary outcomes (ie, stress, preparedness, and pain) were assessed by Visual Analog Scale at 3 time points: baseline at beginning of clinical session (T0), at the end of the clinical session immediately after the intervention (T1), and before the surgery (T2). Pain, satisfaction levels, and postoperative length of stay were evaluated after the surgery (T3). Simulation sickness was assessed after the intervention by use of the Simulation Sickness Questionnaire. A generalized estimating equations model was applied to compare changes in outcomes over time. RESULTS: A total of 74 participants (mean [SD] age, 46.34 [14.52] years; 38 men [51.4%] and 36 women [48.6%]) were recruited and randomized to the control group (37 participants) and intervention group (37 participants). Compared with the control group, the VR-based intervention group showed significantly decreased preoperative anxiety at T1 (β, -5.46; 95% CI, -7.60 to -3.32; P < .001) and T2 (β, -5.57; 95% CI, -7.73 to -3.41; P < .001), lower stress at T1 (β, -10.68; 95% CI, -16.00 to -5.36; P < .001) and T2 (β, -5.16; 95% CI, -9.87 to -0.45; P = .03), and higher preparedness at T1 (β, 6.60; 95% CI, 0.97 to 12.19; P = .02). Satisfaction levels were significantly increased in the intervention group vs the control group (mean [SD] score, 81.35 [9.24] vs 65.28 [8.16]; difference, 16.07; 95% CI, 12.00 to 20.15; P < .001). No significant differences in pain and postoperative length of stay were found. CONCLUSIONS AND RELEVANCE: The findings of this study suggest that a VR-based intervention is a feasible and effective way to reduce preoperative anxiety in adult patients undergoing elective surgery. Given the promising results of this study, further study in the form of large-scale, multicenter, randomized clinical trials with broader implementation is warranted. TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR2100051690.

摘要

重要性:术前焦虑在接受择期手术的成年患者中很常见,与负面结果相关。与传统护理相比,基于虚拟现实 (VR) 的干预措施被认为在减轻手术患者焦虑方面更简单、更安全、更有效。

目的:研究基于 VR 的术前教育干预措施在减少择期手术成年患者术前焦虑中的有效性。

设计、设置和参与者:一项评估员设盲的前瞻性随机临床试验,招募了 2022 年 7 月至 12 月期间在香港的一个麻醉前评估诊所接受首次全麻下择期手术的成年患者(年龄 18 岁或以上),预计在未来 2 至 4 周内进行手术。参与者被随机分配到干预组(通过头戴式显示器控制台在手术室进行 8 分钟沉浸式 360° VR 视频游览)或对照组(标准护理)。

主要结果和测量:主要结局是术前焦虑程度,使用阿姆斯特丹术前焦虑和信息量表(范围 6-30;分数越高表示焦虑程度越高)进行评估,次要结局(即压力、准备情况和疼痛)则在 3 个时间点通过视觉模拟量表进行评估:临床会话开始时的基线(T0)、干预结束时立即(T1)和手术前(T2)。手术后(T3)评估疼痛、满意度水平和术后住院时间。手术后通过使用模拟疾病问卷评估模拟疾病。应用广义估计方程模型比较随时间变化的结果。

结果:共招募了 74 名参与者(平均[标准差]年龄,46.34[14.52]岁;38 名男性[51.4%]和 36 名女性[48.6%]),并随机分为对照组(37 名参与者)和干预组(37 名参与者)。与对照组相比,基于 VR 的干预组在 T1(β,-5.46;95%CI,-7.60 至 -3.32;P<0.001)和 T2(β,-5.57;95%CI,-7.73 至 -3.41;P<0.001)时的术前焦虑明显降低,T1(β,-10.68;95%CI,-16.00 至 -5.36;P<0.001)和 T2(β,-5.16;95%CI,-9.87 至 -0.45;P=0.03)时的压力降低,T1(β,6.60;95%CI,0.97 至 12.19;P=0.02)时的准备情况提高。与对照组相比,干预组的满意度明显提高(平均[标准差]评分,81.35[9.24]与 65.28[8.16];差值,16.07;95%CI,12.00 至 20.15;P<0.001)。疼痛和术后住院时间无显著差异。

结论和相关性:本研究结果表明,基于 VR 的干预措施是一种减少择期手术成年患者术前焦虑的可行且有效的方法。鉴于本研究的有希望结果,需要进行更大规模、多中心、随机临床试验,并进行更广泛的实施。

试验注册:中国临床试验注册中心标识符:ChiCTR2100051690。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9220/10618840/191c8be71272/jamanetwopen-e2340588-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9220/10618840/191c8be71272/jamanetwopen-e2340588-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9220/10618840/191c8be71272/jamanetwopen-e2340588-g001.jpg

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本文引用的文献

[1]
Effects of an Immersive Virtual Reality Intervention on Pain and Anxiety Among Pediatric Patients Undergoing Venipuncture: A Randomized Clinical Trial.

JAMA Netw Open. 2023-2-1

[2]
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Neurosurg Rev. 2021-12

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Virtual Reality Intervention Targeting Pain and Anxiety Among Pediatric Cancer Patients Undergoing Peripheral Intravenous Cannulation: A Randomized Controlled Trial.

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Mayo Clin Proc. 2020-6

[10]
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Health Qual Life Outcomes. 2020-3-11

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