Effect of intensive care unit-specific virtual reality (ICU-VR) to improve psychological well-being and quality of life in COVID-19 ICU survivors: a study protocol for a multicentre, randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 22; no. 1; p. 328
• Main Authors: Vlake, Johan H, Van Bommel, Jasper, Wils, Evert-Jan, Korevaar, Tim I M, Hellemons, Merel E, Schut, Anna F C, Labout, Joost A M, Schreuder, Lois L H, Gommers, Diederik, Van Genderen, Michel E
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 05-05-2021; BioMed Central; BMC
• Subjects: Adult; Anxiety; Care and treatment; Clinical trials; Consent; Coronavirus disease 2019 (COVID-19); Coronaviruses; COVID-19; Depression; Depression, Mental; Hospitals; Humans; Intensive care; Intensive Care Units; Intervention; Mental depression; Multicenter Studies as Topic; Netherlands; Ostomy; Outpatient care facilities; Patients; Post traumatic stress disorder; Post-intensive care syndrome (PICS); Post-traumatic stress disorder (PTSD); Psychotherapy; Quality of Life; Randomized Controlled Trials as Topic; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Study Protocol; Subsidies; Survivors; Technology application; Testing; Virtual Reality; Netherlands; SARS-CoV-2; Post-traumatic stress disorder (PTSD); Virtual reality; Depression; Post-intensive care syndrome (PICS); Anxiety; Health-related quality of life (HRQoL); Randomized controlled trial; Coronavirus disease 2019 (COVID-19)
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-021-05271-z

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.
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.
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.
This trial has been retrospectively registered on the Netherlands Trial Register on August 14, 2020 ( NL8835 ).