背景:SARS-CoV-2的爆发导致全世界医院和重症监护病房(ICU)的入院人数急剧增加。需要ICU治疗的2019年严重冠状病毒病(COVID-19)患者通常需要长时间的机械通气,预计容易出现心理障碍,如创伤后应激障碍(PTSD),焦虑和抑郁,对生活质量产生负面影响。迄今为止,目前尚无有效的治疗策略.在目前的审判中,我们旨在评估ICU专用虚拟现实(ICU-VR)干预对COVID-19ICU治疗后心理健康和生活质量的影响.
方法:在这个多中心中,随机对照试验,我们的目的是检查COVID-19特异性ICU-VR,出院后3个月,改善心理健康和生活质量。次要目标是,首先,在随访期间,研究心理健康和生活质量的组内变化以及心理健康和生活质量的组间差异,出院后12个月,其次,检查患者对ICU护理和善后护理的满意度和评级,以及患者对ICU-VR的看法。在鹿特丹四家医院的混合外科ICU中接受COVID-19治疗的80名成年患者,荷兰,将在2020年6月29日至12月31日期间纳入并随机(1:1)到早期或晚期ICU-VR。随机分配到早期ICU-VR的患者将在出院后3个月的门诊就诊期间接受ICU-VR干预,而随机进入晚期ICU-VR的患者将在出院后6个月接受ICU-VR。这项研究的主要结果是心理健康,使用修订的事件量表(IES-R)和医院焦虑和抑郁量表(HADS)的影响进行评估,和生活质量,使用欧洲生活质量5维度(EQ-5D)和RAND-36问卷进行评估,出院后6个月。
结论:目前,对于特定疾病的ICU治疗后的心理后遗症,尚无有效的治疗方法。这项研究的结果将提供见解,虚拟现实是否是一种可用于ICU护理以改善心理健康和生活质量的方式,或满意,在ICU治疗特定疾病如COVID-19后。
背景:该试验已于2020年8月14日在荷兰试验登记册上进行了回顾性注册(NL8835)。
BACKGROUND: The SARS-CoV-2 outbreak has resulted in a tremendous increase in hospital and intensive care unit (ICU) admissions all over the world. Patients with severe coronavirus disease 2019 (COVID-19) warranting ICU treatment usually have prolonged mechanical ventilation and are expected to be prone to develop psychological impairments, such as post-traumatic stress disorder (PTSD), anxiety and depression, which negatively impact quality of life. To date, no effective treatment strategy is available. In the current trial, we aim to assess the effect of an ICU-specific virtual reality (ICU-VR) intervention on psychological well-being and quality of life after COVID-19 ICU treatment.
METHODS: In this multicentre, randomized controlled trial, we aim to examine whether COVID-19-specific ICU-VR, offered 3 months after hospital discharge, improves psychological well-being and quality of life. Secondary objectives are, firstly, to examine the intra-group changes in psychological well-being and quality of life and the inter-group differences in psychological well-being and quality of life during follow-up, up to 12 months after hospital discharge, and secondly, to examine patients\' satisfaction with and rating of ICU care and aftercare and patients\' perspectives on ICU-VR. Eighty adult patients treated for COVID-19 in the mixed-surgical ICUs of four hospitals in Rotterdam, the Netherlands, will be included and randomized (1:1) to either early or late ICU-VR between June 29 and December 31, 2020. Patients randomized to early ICU-VR will receive the ICU-VR intervention during an outpatient clinic visit 3 months after hospital discharge, whereas patients randomized to late ICU-VR will receive ICU-VR 6 months after hospital discharge. Primary outcomes of this study are psychological well-being, assessed using the Impact of Event Scale-Revised (IES-R) and the Hospital Anxiety and Depression Scale (HADS), and quality of life, assessed using the European Quality of Life 5 Dimensions (EQ-5D) and RAND-36 questionnaires, up to 6 months after hospital discharge.
CONCLUSIONS: Currently, an effective treatment for psychological sequelae after ICU treatment for specific illnesses is unavailable. Results from this study will provide insight whether virtual reality is a modality that can be used in ICU aftercare to improve psychological well-being and quality of life, or satisfaction, after ICU treatment for specific illnesses such as COVID-19.
BACKGROUND: This trial has been retrospectively registered on the Netherlands Trial Register on August 14, 2020 ( NL8835 ).