Einzeltreffer — DigiBib

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.

Discussion: 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.

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

Titel:	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.
Autor/in / Beteiligte Person:	Vlake, JH ; Van Bommel, J ; Wils, EJ ; Korevaar, TIM ; Hellemons, ME ; Schut, AFC ; Labout, JAM ; Schreuder, LLH ; Gommers, D ; Van Genderen, ME
Link:	Volltext (PDF) View record at Springer (Volltext)
Zeitschrift:	Trials, Jg. 22 (2021-05-05), Heft 1, S. 328
Veröffentlichung:	[London] : BioMed Central, 2006-, 2021
Medientyp:	academicJournal
ISSN:	1745-6215 (electronic)
DOI:	10.1186/s13063-021-05271-z
Schlagwort:	Adult Humans Intensive Care Units Multicenter Studies as Topic Netherlands Quality of Life Randomized Controlled Trials as Topic SARS-CoV-2 Survivors COVID-19 Virtual Reality
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Clinical Trial Protocol; Journal Article Language: English [Trials] 2021 May 05; Vol. 22 (1), pp. 328. <i>Date of Electronic Publication: </i>2021 May 05. MeSH Terms: COVID-19* ; Virtual Reality* ; Adult ; Humans ; Intensive Care Units ; Multicenter Studies as Topic ; Netherlands ; Quality of Life ; Randomized Controlled Trials as Topic ; SARS-CoV-2 ; Survivors References: Crit Care. 2019 Jun 11;23(1):213. (PMID: 31186070) ; Cochrane Database Syst Rev. 2014 Dec 09;(12):CD010468. (PMID: 25488158) ; Crit Care Med. 2018 Sep;46(9):1393-1401. (PMID: 29787415) ; Behav Res Ther. 2003 Dec;41(12):1489-96. (PMID: 14705607) ; JAMA. 2019 Feb 19;321(7):665-675. (PMID: 30776295) ; Intensive Care Med. 2019 Jun;45(6):806-814. (PMID: 30840124) ; J Intensive Care. 2018 Jan 08;6:2. (PMID: 29340154) ; J Affect Disord. 2019 Oct 1;257:698-709. (PMID: 31382122) ; BMC Health Serv Res. 2017 Jan 24;17(1):77. (PMID: 28118840) ; Cochrane Database Syst Rev. 2018 Oct 13;10:CD012471. (PMID: 30316199) ; Med Educ Online. 2013 Jul 23;18:21747. (PMID: 23883565) ; JAMA. 2020 Apr 7;323(13):1239-1242. (PMID: 32091533) ; Psychosom Med. 2008 May;70(4):512-9. (PMID: 18434495) ; Crit Care Med. 2001 Mar;29(3):573-80. (PMID: 11373423) ; Crit Care Med. 2008 Oct;36(10):2801-9. (PMID: 18766108) ; Front Psychiatry. 2019 Jul 19;10:505. (PMID: 31379623) ; Curr Psychiatry Rep. 2010 Aug;12(4):298-305. (PMID: 20535592) ; Lancet. 2020 Feb 15;395(10223):470-473. (PMID: 31986257) ; Crit Care Med. 2011 Jan;39(1):112-8. (PMID: 21037472) ; Crit Care. 2019 Dec 16;23(1):411. (PMID: 31842929) ; Crit Care. 2005 Apr;9(2):R96-109. (PMID: 15774056) ; Patient Educ Couns. 2014 Jun;95(3):406-13. (PMID: 24746926) ; Eur J Psychotraumatol. 2019 Aug 19;10(1):1654782. (PMID: 31489138) ; Cochrane Database Syst Rev. 2018 Nov 02;11:CD012701. (PMID: 30388297) ; Front Psychol. 2019 Sep 10;10:1758. (PMID: 31551840) ; Am J Respir Crit Care Med. 2020 Apr 15;201(8):P15-P16. (PMID: 32293204) ; Crit Care Med. 2019 Feb;47(2):273-279. (PMID: 30431494) ; Health Econ. 1993 Oct;2(3):217-27. (PMID: 8275167) ; Crit Care Explor. 2021 May 12;3(5):e0388. (PMID: 34079940) ; Acta Psychiatr Scand. 1983 Jun;67(6):361-70. (PMID: 6880820) ; Cyberpsychol Behav. 2007 Oct;10(5):722-4. (PMID: 17927544) ; J Transl Int Med. 2017 Jun 30;5(2):90-92. (PMID: 28721340) ; N Engl J Med. 2011 Apr 7;364(14):1293-304. (PMID: 21470008) ; Addict Behav. 2008 Aug;33(8):1039-47. (PMID: 18501524) ; JAMA. 2019 Jul 16;322(3):229-239. (PMID: 31310299) ; Crit Care Med. 2012 Feb;40(2):502-9. (PMID: 21946660) ; J Intensive Care. 2020 Jan 09;8:6. (PMID: 31938546) ; Lancet. 2020 Feb 15;395(10223):497-506. (PMID: 31986264) ; JAMA. 2020 Apr 28;323(16):1545-1546. (PMID: 32167538) ; Health Policy. 1990 Dec;16(3):199-208. (PMID: 10109801) ; Lancet. 2020 Feb 15;395(10223):507-513. (PMID: 32007143) ; Minerva Anestesiol. 2015 Feb;81(2):135-44. (PMID: 24824957) ; Nurs Crit Care. 2021 Mar;26(2):102-108. (PMID: 32734674) ; Crit Care Med. 2015 Mar;43(3):642-53. (PMID: 25513784) ; Psychol Med. 2013 Dec;43(12):2657-71. (PMID: 23438256) ; Value Health. 2016 Jun;19(4):343-52. (PMID: 27325326) ; Chin Med J (Engl). 2020 May 5;133(9):1025-1031. (PMID: 32044814) ; Ann Surg. 2017 Jun;265(6):1068-1073. (PMID: 27906757) Contributed Indexing: Keywords: Anxiety; Coronavirus disease 2019 (COVID-19); Depression; Health-related quality of life (HRQoL); Post-intensive care syndrome (PICS); Post-traumatic stress disorder (PTSD); Randomized controlled trial; SARS-CoV-2; Virtual reality Entry Date(s): Date Created: 20210506 Date Completed: 20210617 Latest Revision: 20240402 Update Code: 20240402 PubMed Central ID: PMC8097671

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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.