Study Results
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Basic Information
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SUSPENDED
NA
920 participants
INTERVENTIONAL
2021-04-14
2023-06-30
Brief Summary
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Stimulation will be provided for 30 minutes, three times a day, evenly spaced between 7:00 AM and 7:00 PM, using a commercially available head-mounted display. The investigators hypothesize that by providing relaxing virtual environments to patients through a head-mounted display and headphones, the incidence of delirium will be lower compared to the control group receiving no VR stimulation. Secondary outcomes will include evaluating the movement patterns and intensity between the intervention and control group, and between patients with and without delirium, using inertial measurement units and an under mattress bed sensor. It is hypothesized that it will be possible to detect difference in movement patterns between groups and identify patterns indicating the presence or absence of delirium. Secondary objective also include the evaluation of the effect of VR on duration of delirium. Here it is hypothesized that the duration of delirium will be shorter in participants receiving the VR stimulation compared to those in the control group. Physiological parameters (e.g. heart rate, respiration rate, oxygen saturation, etc.) will also be recorded during the stimulation to further understand what, if any, effect VR has.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention
Participants who will be receiving standard ICU care and additionally the VR stimulation during their ICU stay.
VR Stimulation
Participants in the intervention group will be provided with 30 minutes of relaxing, 360-degree virtual reality stimulation and corresponding sounds, three times a day (morning, midday, evening) everyday during their stay in the ICU, up to a maximum of 14 days.
Control
Patients in the ICU who will be receiving standard ICU care during their ICU stay. Participants in this arm will not be receiving VR stimulation.
No interventions assigned to this group
Interventions
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VR Stimulation
Participants in the intervention group will be provided with 30 minutes of relaxing, 360-degree virtual reality stimulation and corresponding sounds, three times a day (morning, midday, evening) everyday during their stay in the ICU, up to a maximum of 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No severe visual or auditory impairments (strabismus, macular degeneration, retinopathy)
* Estimated length of stay \>24 hours
* Can keep eyes open for at least 30 seconds
* German or French speaking
Exclusion Criteria
* Recent history of major depression
* Admission for drug overdose
18 Years
ALL
No
Sponsors
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University of Bern
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Matthias Hänggi, Dr. med
Role: PRINCIPAL_INVESTIGATOR
Department of Intensive Care Medicine, University Hospital Bern (Inelspital)
Locations
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Inselspital
Bern, , Switzerland
Countries
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References
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Chanques G, Ely EW, Garnier O, Perrigault F, Eloi A, Carr J, Rowan CM, Prades A, de Jong A, Moritz-Gasser S, Molinari N, Jaber S. The 2014 updated version of the Confusion Assessment Method for the Intensive Care Unit compared to the 5th version of the Diagnostic and Statistical Manual of Mental Disorders and other current methods used by intensivists. Ann Intensive Care. 2018 Mar 1;8(1):33. doi: 10.1186/s13613-018-0377-7.
Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
Santos E, Cardoso D, Neves H, Cunha M, Rodrigues M, Apostolo J. Effectiveness of haloperidol prophylaxis in critically ill patients with a high risk of delirium: a systematic review. JBI Database System Rev Implement Rep. 2017 May;15(5):1440-1472. doi: 10.11124/JBISRIR-2017-003391.
Pandharipande PP, Girard TD, Ely EW. Long-term cognitive impairment after critical illness. N Engl J Med. 2014 Jan 9;370(2):185-6. doi: 10.1056/NEJMc1313886. No abstract available.
Girard TD, Exline MC, Carson SS, Hough CL, Rock P, Gong MN, Douglas IS, Malhotra A, Owens RL, Feinstein DJ, Khan B, Pisani MA, Hyzy RC, Schmidt GA, Schweickert WD, Hite RD, Bowton DL, Masica AL, Thompson JL, Chandrasekhar R, Pun BT, Strength C, Boehm LM, Jackson JC, Pandharipande PP, Brummel NE, Hughes CG, Patel MB, Stollings JL, Bernard GR, Dittus RS, Ely EW; MIND-USA Investigators. Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness. N Engl J Med. 2018 Dec 27;379(26):2506-2516. doi: 10.1056/NEJMoa1808217. Epub 2018 Oct 22.
Serafim RB, Bozza FA, Soares M, do Brasil PE, Tura BR, Ely EW, Salluh JI. Pharmacologic prevention and treatment of delirium in intensive care patients: A systematic review. J Crit Care. 2015 Aug;30(4):799-807. doi: 10.1016/j.jcrc.2015.04.005. Epub 2015 Apr 17.
Zayed Y, Barbarawi M, Kheiri B, Banifadel M, Haykal T, Chahine A, Rashdan L, Aburahma A, Bachuwa G, Seedahmed E. Haloperidol for the management of delirium in adult intensive care unit patients: A systematic review and meta-analysis of randomized controlled trials. J Crit Care. 2019 Apr;50:280-286. doi: 10.1016/j.jcrc.2019.01.009. Epub 2019 Jan 12.
Gerber SM, Jeitziner MM, Knobel SEJ, Mosimann UP, Muri RM, Jakob SM, Nef T. Perception and Performance on a Virtual Reality Cognitive Stimulation for Use in the Intensive Care Unit: A Non-randomized Trial in Critically Ill Patients. Front Med (Lausanne). 2019 Dec 10;6:287. doi: 10.3389/fmed.2019.00287. eCollection 2019.
Gerber SM, Jeitziner MM, Wyss P, Chesham A, Urwyler P, Muri RM, Jakob SM, Nef T. Visuo-acoustic stimulation that helps you to relax: A virtual reality setup for patients in the intensive care unit. Sci Rep. 2017 Oct 16;7(1):13228. doi: 10.1038/s41598-017-13153-1.
Bergeron N, Dubois MJ, Dumont M, Dial S, Skrobik Y. Intensive Care Delirium Screening Checklist: evaluation of a new screening tool. Intensive Care Med. 2001 May;27(5):859-64. doi: 10.1007/s001340100909.
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
Linacre JM, Heinemann AW, Wright BD, Granger CV, Hamilton BB. The structure and stability of the Functional Independence Measure. Arch Phys Med Rehabil. 1994 Feb;75(2):127-32.
Naef AC, Jeitziner MM, Gerber SM, Jenni-Moser B, Muri RM, Jakob SM, Nef T, Hanggi M. Virtual reality stimulation to reduce the incidence of delirium in critically ill patients: study protocol for a randomized clinical trial. Trials. 2021 Mar 1;22(1):174. doi: 10.1186/s13063-021-05090-2.
Other Identifiers
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2020-00039
Identifier Type: OTHER
Identifier Source: secondary_id
KEK2020-00039
Identifier Type: -
Identifier Source: org_study_id
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