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

Johan Hendrik Vlake, Jasper van Bommel, Evert Jan Wils, Tim Im Korevaar, Fabio Taccone, Anna Fc Schut, Jan H. Elderman, Joost Am Labout, Adrienne Mtj Raben, Annemieke Dijkstra, Sefanja Achterberg, Amber L. Jurriens, Margo Mc Van Mol, Diederik Gommers, Michel E. Van Genderen*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

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.

Original languageEnglish
Article numbere061876
JournalBMJ Open
Volume12
Issue number9
DOIs
Publication statusPublished - 20 Sept 2022

Bibliographical note

Funding Information:
This study was supported by DSW (for the HORIZON-IC project; no grant number available), Stichting Theia (grant number: 2020286), Stichting SGS (grant number: 2020355) and BeterKeten (for the HORIZON-IC project; no grant number available). The funding sources had no role in the design of the study and collection, analysis, and interpretation of data nor in writing the manuscript.

Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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