Virtual Reality to Reduce Delirium

NCT04498585 | Suspended DMC

• 2 other identifiers: KEK2020-000392020-00039
• Study Type: interventional
• Target: 920
• Locations: 1 country
• Sites: 1

Brief Summary

Delirium has been long considered as a major contributor to cognitive impairments following a critical illness. Currently, both pharmacologic and non-pharmacologic prevention and treatment strategies are used in the intensive care unit, despite these strategies remaining controversial. However, with previous studies showing the feasibility of using virtual reality (VR) within the critical care setting, the investigators propose to use this technology to investigate the effect of 360-degree immersive virtual reality stimulation on the incidence of delirium in the ICU. 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.

Conditions

Delirium; Cognitive Impairment

Keywords

Virtual Reality; Delirium; Intensive Care Unit; Critical Care; Movement Analysis

Outcome Measures

Primary Outcomes (1)

• Incidence of Delirium

  Delirium will be assessed 3 times a day using the Intensive Care Delirium Screening Checklist. The screening will be conducted by trained critical care nurses. If a score greater than or equal to 4 is recorded, this will count as an incidence of delirium.

  Number of incidences during stay in the intensive care unit (to a maximum of 14 days)

Secondary Outcomes (3)

• Pattern of the movements before and during delirium

  Recorded during entire stay in the ICU (to a maximum of 14 days)

• Intensity of the movements before and during delirium

  Recorded during entire stay in the ICU (to a maximum of 14 days)

• Duration of Delirium

  Recorded during entire stay in the ICU (to a maximum of 14 days)

Other Outcomes (8)

• Cognitive Functioning

  Compared between functioning at discharge to 6-months post-discharge.

• Health Related Quality of Life

  Compared between quality pre-admission to 6-months post-discharge.

• Functional Independence

  Compared between quality pre-admission to 6-months post-discharge.

Study Arms (2)

Intervention

EXPERIMENTAL

Participants who will be receiving standard ICU care and additionally the VR stimulation during their ICU stay.

Other: VR Stimulation

Control

NO INTERVENTION

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.

Interventions

VR Stimulation OTHER

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.

Also known as: Visuo-acoustic stimulation

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self identified gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written Informed Consent (by the patient, relatives, or authorized representative)
• 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

You may not qualify if:

• Known psychotic disorders associated with delusions (e.g. schizophrenia)
• Recent history of major depression
• Admission for drug overdose

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

Location

Related Publications (14)

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  PMID: 29492696 BACKGROUND

• 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.

  PMID: 30113379 BACKGROUND

• 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.

  PMID: 28498176 BACKGROUND

• 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.

  PMID: 24401069 BACKGROUND

• 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.

  PMID: 30346242 BACKGROUND

• 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.

  PMID: 25957498 BACKGROUND

• 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.

  PMID: 30665181 BACKGROUND

• 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.

  PMID: 31921867 BACKGROUND

• 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.

  PMID: 29038450 BACKGROUND

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  PMID: 8311667 BACKGROUND

• 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.

  PMID: 33648572 DERIVED

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Matthias Hänggi, Dr. med

  Department of Intensive Care Medicine, University Hospital Bern (Inelspital)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 4, 2020
• Study Start: April 14, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be shared once study results have been published.
• Access Criteria: To be determined.

Locations

CH (1)