虚拟现实对妇科手术患者焦虑和疼痛的影响(VRAP-G);随机对照试验

Kreijveld Bj, Bekkers Ipw, E. Mulder, Wassen Mmlh
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摘要

背景:缺乏术后急性疼痛管理与发病率增加、恢复时间延长、阿片类药物使用增加以及随后的医疗费用增加有关。越来越多的证据表明,虚拟现实(VR)在减轻急性疼痛方面是有效的。减少术后疼痛和多模式镇痛的替代方法对于术后急性疼痛管理和减少阿片类药物的使用及其不良反应是必要的。本研究的目的是探讨VR对妇科择期手术后疼痛的影响。方法和设计:该研究涉及一项非盲、单中心、随机对照试验。符合入选标准并在Zuyderland医疗中心接受选择性妇科手术的合格女性将被随机分配参加。研究人群将被随机分为干预组(VR组)或标准护理组。除了通常的标准护理外,干预组可以在术前和术后选择沉浸式引导放松VR体验或互动VR体验。随机分配到标准护理组的参与者将只接受通常的标准护理,包括术前和术后护理。主要结果是用数字评定量表(NRS)测量术后疼痛。每组共有30名患者。这意味着总共有60名女性将被纳入这项研究。次要结果是:;评估两组患者术前和术后的焦虑、疼痛灾难、镇痛药的使用、住院时间,并探讨VR使用的耐受性、可行性和满意度。讨论:这项研究将深入了解在接受妇科手术的女性中,VR是否是减少术后疼痛和随后阿片类药物使用的有效方法。
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The Effect of Virtual Reality on Anxiety and Pain in Patients Undergoing Gynecological Surgery (VRAP-G); a Randomized Controlled Trial
Background: Lack of postoperative acute pain management is associated with increased morbidity, longer recovery time, more opioid use and subsequently increased health care costs. There is increasing evidence that Virtual Reality (VR) is effective in the reduction of acute pain. Alternative methods to reduce postoperative pain and multimodal analgesia are necessary for acute postoperative pain management and to reduce opioid use and their adverse effects. The aim of this study is to explore the effect of VR on pain in the postoperative period after elective gynecological surgery. Methods and Design: The study concerns a non-blinded, single center, randomized controlled trial. Eligible women fulfilling the inclusion criteria and receive elective gynecological surgery in the Zuyderland Medical Center will be randomized for participation. The study population will be randomly divided into the intervention group (VR-group) or the standard care- group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the pre- and postoperative period additional to the usual standard care. The participants randomized to the standard caregroup will receive only the usual standard care pre-and postoperative. The primary outcome is postoperative pain measured on a Numeric Rating Scale (NRS). A total of 30 patients have to be included in each group. This means that a total of 60 women will have to be included in this study. Secondary outcomes are; evaluating pre-and postoperative anxiety, pain catastrophizing, analgesic use, length of hospital stay between both groups and to explore tolerability, feasibility and satisfaction of VR use. Discussion: This study will provide insight as to whether in women who receive gynecological surgery, VR is an effective method to reduce postoperative pain and subsequently opioid use.
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