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VR就绪:一项针对共同制定的精神性干预措施在近期入住重症监护病房患者中进行恢复干预的非随机、单臂、混合方法可行性试验的方案。 (注:原文中“itual ality”可能有误,推测正确表述可能是“spiritualality”之类,按此理解翻译)

VR READY: a protocol for a non-randomised, single-arm, mixed methods, feasibility trial of a coproduced itual ality intervention to i recover in people recently admitted to intensive care.

作者信息

Drew Cheney J G, Smallman Kim, Gill Sarah, Greenstock Craig, Cullen Katherine, Irving Alys, Twose Paul, Battle Ceri, White Domonic, Smalley Michelle, Lynch Ceri

机构信息

Centre For Trials Research, Cardiff University, Cardiff, UK

Centre For Trials Research, Cardiff University, Cardiff, UK.

出版信息

BMJ Open. 2025 Aug 12;15(8):e102688. doi: 10.1136/bmjopen-2025-102688.

Abstract

INTRODUCTION

Post-intensive care syndrome (PICS) describes a cluster of ongoing symptoms experienced by a large proportion of patients previously admitted to critical care. Despite a large rise in survival following critical care, interventions to support recovery and combat PICS are lacking. It has been suggested that the use of digital tools such as virtual reality (VR) may play a useful role in the development of recovery-supporting interventions. We engaged with people with lived experience of critical care admission to coproduce a VR intervention (itual ality to i recover post ICU (VR READY)). Here, we present a protocol for the initial feasibility and acceptability testing of this intervention.

METHODS AND ANALYSIS

This is a single-arm, single-site, non-randomised feasibility trial of VR READY. Up to 25 participants recently admitted to critical care will be recruited to use the VR READY intervention for at least 5 min per day for a period of 14 days. Participants must have capacity to consent and be free from ongoing delirium in order to participate. Outcomes relating to sleep and well-being will be measured at baseline and at day 14 after intervention delivery. The primary outcome is feasibility, which will be assessed according to prespecified criteria. Participants will complete a qualitative interview to assess acceptability of the intervention, trial design and outcomes approximately 1 month after completing the intervention period. No formal statistical analysis of outcomes will be conducted, but these will be summarised descriptively. Interviews will be subjected to reflexive thematic analysis.

ETHICS AND DISSEMINATION

This study received a favourable ethical opinion by North-East York Research Ethics Committee (Ref 23/NE/0113) in June 2024. Study results will be disseminated through the peer review literature, ISRCTN registry and directly to participants, which will be facilitated by the study public and patient involvement steering group.

TRIAL REGISTRATION NUMBER

ISRCTN88854487.

摘要

引言

重症监护后综合征(PICS)描述了很大一部分曾入住重症监护病房的患者所经历的一系列持续症状。尽管重症监护后的生存率大幅提高,但支持康复和对抗PICS的干预措施却很缺乏。有人认为,使用虚拟现实(VR)等数字工具可能在开发支持康复的干预措施中发挥有益作用。我们与有重症监护住院经历的人合作,共同制作了一种VR干预措施(重症监护后恢复的虚拟现实疗法(VR READY))。在此,我们介绍该干预措施初步可行性和可接受性测试的方案。

方法与分析

这是一项针对VR READY的单臂、单中心、非随机可行性试验。将招募多达25名近期入住重症监护病房的参与者,让他们每天使用VR READY干预措施至少5分钟,为期14天。参与者必须有同意的能力且无持续性谵妄才能参与。与睡眠和幸福感相关的结果将在基线时以及干预实施后的第14天进行测量。主要结果是可行性,将根据预先确定的标准进行评估。参与者将在完成干预期约1个月后完成一次定性访谈,以评估干预措施、试验设计和结果的可接受性。不对结果进行正式的统计分析,但将对其进行描述性总结。访谈将进行反思性主题分析。

伦理与传播

本研究于2024年6月获得东北约克研究伦理委员会的有利伦理意见(参考号23/NE/0113)。研究结果将通过同行评审文献、ISRCTN注册库并直接传达给参与者,这将由研究公众和患者参与指导小组提供便利。

试验注册号

ISRCTN88854487。

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