Intensive Care Unit-Specific Virtual Reality for Critically Ill Patients With COVID-19: Multicenter Randomized Controlled Trial.

BACKGROUND: Although psychological sequelae after intensive care unit (ICU) treatment are considered quite intrusive, robustly effective interventions to treat or prevent these long-term sequelae are lacking. Recently, it was demonstrated that ICU-specific virtual reality (ICU-VR) is a feasible and acceptable intervention with potential mental health benefits. However, its effect on mental health and ICU aftercare in COVID-19 ICU survivors is unknown. OBJECTIVE: This study aimed to explore the effects of ICU-VR on mental health and on patients' perceived quality of, satisfaction with, and rating of ICU aftercare among COVID-19 ICU survivors. METHODS: This was a multicenter randomized controlled trial. Patients were randomized to either the ICU-VR (intervention) or the control group. All patients were invited to an COVID-19 post-ICU follow-up clinic 3 months after hospital discharge, during which patients in the intervention group received ICU-VR. One month and 3 months later (4 and 6 months after hospital discharge), mental health, quality of life, perceived quality, satisfaction with, and rating of ICU aftercare were scored using questionnaires. RESULTS: Eighty-nine patients (median age 58 years; 63 males, 70%) were included. The prevalence and severity of psychological distress were limited throughout follow-up, and no differences in psychological distress or quality of life were observed between the groups. ICU-VR improved satisfaction with (mean score 8.7, SD 1.6 vs 7.6, SD 1.6 [ICU-VR vs control]; t64=-2.82, P=.006) and overall rating of ICU aftercare (mean overall rating of aftercare 8.9, SD 0.9 vs 7.8, SD 1.7 [ICU-VR vs control]; t64=-3.25; P=.002) compared to controls. ICU-VR added to the quality of ICU aftercare according to 81% of the patients, and all patients would recommend ICU-VR to other ICU survivors. CONCLUSIONS: ICU-VR is a feasible and acceptable innovative method to improve satisfaction with and rating of ICU aftercare and adds to its perceived quality. We observed a low prevalence of psychological distress after ICU treatment for COVID-19, and ICU-VR did not improve psychological recovery or quality of life. Future research is needed to confirm our results in other critical illness survivors to potentially facilitate ICU-VR's widespread availability and application during follow-up. TRIAL REGISTRATION: Netherlands Trial Register NL8835; https://www.trialregister.nl/trial/8835. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-021-05271-z.

Effect of intensive care unit-specific virtual reality (ICU-VR) to improve psychological well-being in ICU survivors: study protocol for an international, multicentre, randomised controlled trial-the HORIZON-IC study.

INTRODUCTION: A substantial proportion of intensive care unit (ICU) survivors develop psychological impairments after ICU treatment, part of the postintensive care syndrome, resulting in a decreased quality of life. Recent data suggest that an ICU-specific virtual reality intervention (ICU-VR) for post-ICU patients is feasible and safe, improves satisfaction with ICU aftercare, and might improve psychological sequelae. In the present trial, we firstly aim to determine whether ICU-VR is effective in mitigating post-traumatic stress disorder (PTSD)-related symptoms and secondly to determine the optimal timing for initiation with ICU-VR. METHODS AND ANALYSIS: This international, multicentre, randomised controlled trial will be conducted in 10 hospitals. Between December 2021 and April 2023, we aim to include 300 patients who have been admitted to the ICU ≥72 hours and were mechanically ventilated ≥24 hours. Patients will be followed for 12 consecutive months. Patients will be randomised in a 1:1:1 ratio to the early ICU-VR group, the late ICU-VR group, or the usual care group. All patients will receive usual care, including a mandatory ICU follow-up clinic visit 3 months after ICU discharge. Patients in the early ICU-VR group will receive ICU-VR within 2 weeks after ICU discharge. Patients in the late VR group will receive ICU-VR during the post-ICU follow-up visit. The primary objective is to assess the effect of ICU-VR on PTSD-related symptoms. Secondary objectives are to determine optimal timing for ICU-VR, to assess the effects on anxiety-related and depression-related symptoms and health-related quality of life, and to assess patient satisfaction with ICU aftercare and perspectives on ICU-VR. ETHICS AND DISSEMINATION: The Medical Ethics Committee United, Nieuwegein, the Netherlands, approved this study and local approval was obtained from each participating centre (NL78555.100.21). Our findings will be disseminated by presentation of the results at (inter)national conferences and publication in scientific, peer-reviewed journals. TRIAL REGISTRATION NUMBER: NL9812.