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

• Published in: BMJ open Vol. 12; no. 9; p. e061876
• Main Authors: Vlake, Johan Hendrik, van Bommel, Jasper, Wils, Evert-Jan, Korevaar, Tim IM, Taccone, Fabio, Schut, Anna FC, Elderman, Jan H, Labout, Joost AM, Raben, Adrienne MTJ, Dijkstra, Annemieke, Achterberg, Sefanja, Jurriens, Amber L, Van Mol, Margo MC, Gommers, Diederik, Van Genderen, Michel E
• Format: Journal Article
• Language: English
• Published: London British Medical Journal Publishing Group 20.09.2022; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Protocol
• Subjects: Adult intensive & critical care; Anxiety; Delirium; Informed consent; INTENSIVE & CRITICAL CARE; Intensive Care; Intervention; Mental depression; Mental disorders; Patient satisfaction; Post traumatic stress disorder; Quality of life; Questionnaires; Review boards; Schweitzer, Albert; Scripts; Teaching hospitals; Virtual reality; Belgium; Netherlands
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2022-061876

IntroductionA 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 analysisThis 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 disseminationThe 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 numberNL9812.