{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:27:52Z","timestamp":1792787272591,"version":"4.5.0"},"reference-count":37,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2025,1,15]],"date-time":"2025-01-15T00:00:00Z","timestamp":1736899200000},"content-version":"unspecified","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"the Science and Technology Project of Shenzhen","award":["JCYJ20230807142300002"],"award-info":[{"award-number":["JCYJ20230807142300002"]}]},{"DOI":"10.13039\/501100002858","name":"the China Postdoctoral Science Foundation","doi-asserted-by":"crossref","award":["2023M731551"],"award-info":[{"award-number":["2023M731551"]}],"id":[{"id":"10.13039\/501100002858","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,10,30]]},"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Delirium is a common acute cognitive impairment characterised by confusion, disorientation and attention deficits, particularly prevalent in intensive care unit (ICU) settings. Given its significant impact on patients, caregivers and healthcare resources, preventing delirium in patients in the ICU is of paramount importance. This is the first randomised-controlled trial designed to evaluate the effects of a virtual reality-based sensory stimulation intervention on preventing delirium in ICU patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      We employed a paired randomisation method to match eligible participants based on a validated delirium risk scoring model for patients in the ICU. The study will commence in September 2024 and conclude in June 2026. A consecutive sample of 198 patients in the ICU admitted to the study setting will be recruited. Eligible participants will be randomly allocated to receive either virtual reality-based sensory stimulation in addition to usual care or usual care alone. The virtual reality-based sensory stimulation intervention will last for up to 14 days, with all interventions administered by a research team. We define delirium-free days over a 14-day period as the primary outcome. The secondary outcomes will include delirium incidence, duration and severity; patients\u2019 psychological well-being (post-traumatic stress disorder, sleep quality and ICU memory); patients\u2019 clinical outcomes and other outcomes (quality of life, independence and cognitive function). Data will be collected at baseline, post-intervention and 6\u2009months post-intervention. Two independent t-tests or Wilcoxon-Mann-Whitney tests will be used for continuous variables, while \u03c7\n                      <jats:sup>2<\/jats:sup>\n                      or Fisher\u2019s exact tests will be employed for categorical variables. The analysis will adhere to both the intention-to-treat and per-protocol principles. Additionally, mixed-effects models and subgroup analysis will be planned.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This protocol was approved by the Research Ethics Committee of Shenzhen Hospital of Southern Medical University (NYSZYYEC20230068). All participants or their family caregivers will provide written informed consent. Results will be disseminated through scientific publications, and presentations at local and international conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06153472\">NCT06153472<\/jats:ext-link>\n                      . Trial registration date: 22 November 2023.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-083966","type":"journal-article","created":{"date-parts":[[2025,1,16]],"date-time":"2025-01-16T04:00:35Z","timestamp":1737000035000},"page":"e083966","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Effectiveness of a virtual reality-based sensory stimulation intervention in preventing delirium in intensive care units: a randomised-controlled trial protocol"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06153472","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1820-5867","authenticated-orcid":false,"given":"Surui","family":"Liang","sequence":"first","affiliation":[{"name":"Tung Wah College, Kowloon, Hong Kong"},{"name":"Shenzhen Hospital of Southern Medical University, Shenzhen, Guangdong, 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The dreams project: improving the intensive care patient experience with virtual reality. Available: https:\/\/arxiv.org\/abs\/1906.11706 [Accessed 13 Oct 2023]."},{"key":"2025081402522244000_15.1.e083966.17","article-title":"Improving the Intensive Care Patient Experience With Virtual Reality-A Feasibility Study","volume":"2","author":"Ong","year":"2020","journal-title":"Crit Care Explor"},{"key":"2025081402522244000_15.1.e083966.18","doi-asserted-by":"crossref","first-page":"503","DOI":"10.1089\/cyber.2009.0308","article-title":"Restorative effects of virtual nature settings","volume":"13","author":"Valtchanov","year":"2010","journal-title":"Cyberpsychol Behav Soc Netw"},{"key":"2025081402522244000_15.1.e083966.19","doi-asserted-by":"publisher","DOI":"10.1080\/10937404.2016.1196155"},{"key":"2025081402522244000_15.1.e083966.20","doi-asserted-by":"crossref","DOI":"10.1038\/s41598-017-01242-0","article-title":"Effectiveness of Immersive Videos in Inducing Awe: An Experimental Study","volume":"7","author":"Chirico","year":"2017","journal-title":"Sci Rep"},{"key":"2025081402522244000_15.1.e083966.21","doi-asserted-by":"crossref","DOI":"10.1186\/1472-6963-6-11","article-title":"Referral from secondary care and to aftercare in a tertiary care university hospital in Japan","volume":"6","author":"Toyabe","year":"2006","journal-title":"BMC Health Serv Res"},{"key":"2025081402522244000_15.1.e083966.22","doi-asserted-by":"publisher","DOI":"10.1001\/jama.289.22.2983"},{"key":"2025081402522244000_15.1.e083966.23","doi-asserted-by":"crossref","first-page":"1423","DOI":"10.1016\/j.ijnurstu.2015.04.021","article-title":"The effects of a tailored intensive care unit delirium prevention protocol: A randomized controlled trial","volume":"52","author":"Moon","year":"2015","journal-title":"Int J Nurs Stud"},{"key":"2025081402522244000_15.1.e083966.24","doi-asserted-by":"crossref","first-page":"221","DOI":"10.1111\/nicc.12288","article-title":"A post cardiac surgery intervention to manage delirium involving families: a randomized pilot study","volume":"22","author":"Mailhot","year":"2017","journal-title":"Nurs Crit Care"},{"key":"2025081402522244000_15.1.e083966.25","doi-asserted-by":"crossref","first-page":"234","DOI":"10.1016\/j.hrtlng.2017.05.002","article-title":"Delirium prevention in critically ill adults through an automated reorientation intervention \u2013 A pilot randomized controlled trial","volume":"46","author":"Munro","year":"2017","journal-title":"Heart Lung"},{"key":"2025081402522244000_15.1.e083966.26","unstructured":"Zou J . Reliability and Validity Test of Chinese Version of CAM-ICU and Comparison with Other Scales. Huazhong University of Science and Technology, 2012."},{"key":"2025081402522244000_15.1.e083966.27","doi-asserted-by":"crossref","first-page":"851","DOI":"10.1097\/CCM.0000000000002368","article-title":"The CAM-ICU-7 Delirium Severity Scale: A novel delirium severity instrument for use in the Intensive Care Unit","volume":"45","author":"Khan","year":"2017","journal-title":"Crit Care Med"},{"key":"2025081402522244000_15.1.e083966.28","unstructured":"Weathers FW , Litz BT , Herman DS , et al . The PTSD Checklist (PCL): Reliability, Validity, and Diagnostic Utility. 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