<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04498585</url>
  </required_header>
  <id_info>
    <org_study_id>KEK2020-00039</org_study_id>
    <secondary_id>2020-00039</secondary_id>
    <nct_id>NCT04498585</nct_id>
  </id_info>
  <brief_title>Virtual Reality to Reduce Delirium</brief_title>
  <official_title>Virtual Reality Stimulation to Relax and Reduce the Incidence of Delirium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Delirium has been long considered as a major contributor to cognitive impairments following a&#xD;
      critical illness. Currently, both pharmacologic and non-pharmacologic prevention and&#xD;
      treatment strategies are used in the intensive care unit, despite these strategies remaining&#xD;
      controversial. However, with previous studies showing the feasibility of using virtual&#xD;
      reality (VR) within the critical care setting, the investigators propose to use this&#xD;
      technology to investigate the effect of 360-degree immersive virtual reality stimulation on&#xD;
      the incidence of delirium in the ICU.&#xD;
&#xD;
      Stimulation will be provided for 30 minutes, three times a day, evenly spaced between 7:00 AM&#xD;
      and 7:00 PM, using a commercially available head-mounted display. The investigators&#xD;
      hypothesize that by providing relaxing virtual environments to patients through a&#xD;
      head-mounted display and headphones, the incidence of delirium will be lower compared to the&#xD;
      control group receiving no VR stimulation. Secondary outcomes will include evaluating the&#xD;
      movement patterns and intensity between the intervention and control group, and between&#xD;
      patients with and without delirium, using inertial measurement units and an under mattress&#xD;
      bed sensor. It is hypothesized that it will be possible to detect difference in movement&#xD;
      patterns between groups and identify patterns indicating the presence or absence of delirium.&#xD;
      Secondary objective also include the evaluation of the effect of VR on duration of delirium.&#xD;
      Here it is hypothesized that the duration of delirium will be shorter in participants&#xD;
      receiving the VR stimulation compared to those in the control group. Physiological parameters&#xD;
      (e.g. heart rate, respiration rate, oxygen saturation, etc.) will also be recorded during the&#xD;
      stimulation to further understand what, if any, effect VR has.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Decreased resources due to COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">April 14, 2021</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Delirium</measure>
    <time_frame>Number of incidences during stay in the intensive care unit (to a maximum of 14 days)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pattern of the movements before and during delirium</measure>
    <time_frame>Recorded during entire stay in the ICU (to a maximum of 14 days)</time_frame>
    <description>Movement patterns, measured as acceleration and rotation, will be measured using inertial measurement units. The data will be used to determine if there is a change in pattern or intensity between periods before and during delirium.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of the movements before and during delirium</measure>
    <time_frame>Recorded during entire stay in the ICU (to a maximum of 14 days)</time_frame>
    <description>Movement patterns, measured as acceleration and rotation, will be measured using inertial measurement units. The data will be used to determine if there is a change in intensity between periods before and during delirium.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Delirium</measure>
    <time_frame>Recorded during entire stay in the ICU (to a maximum of 14 days)</time_frame>
    <description>The duration of delirium will be evaluated per 8 hour periods, or as needed, while patients are in the ICU. If the participant is assessed as delirious during any of the assessments during an 8 hour span, the entire period will count as delirious.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cognitive Functioning</measure>
    <time_frame>Compared between functioning at discharge to 6-months post-discharge.</time_frame>
    <description>Cognitive abilities will be measured using the Montreal Cognitive Assessment (MoCA).</description>
  </other_outcome>
  <other_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>Compared between quality pre-admission to 6-months post-discharge.</time_frame>
    <description>Quality of life is examined via the EQ-5D questionnaire (official name, not abbreviated). The five-level version (5L) will be used. The five levels of the scale, scored from 1 to 5 are: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The numbers for the five dimensions are subsequently combined to create a unique 5-digit code which represents the respondent's overall health state. This means an index of 11111 is the best possible health, and 55555 is the worst possible health.</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional Independence</measure>
    <time_frame>Compared between quality pre-admission to 6-months post-discharge.</time_frame>
    <description>Independence is examined using the Functional Independence Measure (FIM).</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart Rate</measure>
    <time_frame>Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).</time_frame>
    <description>Changes in heart rate (beats per minute) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).</time_frame>
    <description>Changes in blood pressure (mmHg) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Respiration Rate</measure>
    <time_frame>Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).</time_frame>
    <description>Changes in respiration rate (breaths per minute) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Oxygen Saturation</measure>
    <time_frame>Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).</time_frame>
    <description>Changes in oxygen saturation (%) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.</description>
  </other_outcome>
  <other_outcome>
    <measure>System Usability Scale</measure>
    <time_frame>Once a day for the duration of the patient's time in the ICU (to a maximum of 14 days).</time_frame>
    <description>The 10-item System Usability Scale is used to collect data on the user's (nurse providing VR stimulation) subjective usability assessments. There are five response options per question; from Strongly disagree (1) to Strongly agree (5). For each odd numbered question, subtract 1 from the score. For each even numbered question, subtract the score from 5. Add up the new values calculated and multiply this total by 2.5. This gives a final score from 0 - 100 (this is not a percentage, but values can be normalized to produce a percentile ranking). A score above 68 is considered above average, and below 68 is below average.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">920</enrollment>
  <condition>Delirium</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who will be receiving standard ICU care and additionally the VR stimulation during their ICU stay.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>VR Stimulation</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Visuo-acoustic stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written Informed Consent (by the patient, relatives, or authorized representative)&#xD;
&#xD;
          -  No severe visual or auditory impairments (strabismus, macular degeneration,&#xD;
             retinopathy)&#xD;
&#xD;
          -  Estimated length of stay &gt;24 hours&#xD;
&#xD;
          -  Can keep eyes open for at least 30 seconds&#xD;
&#xD;
          -  German or French speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known psychotic disorders associated with delusions (e.g. schizophrenia)&#xD;
&#xD;
          -  Recent history of major depression&#xD;
&#xD;
          -  Admission for drug overdose&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self identified gender</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Hänggi, Dr. med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Intensive Care Medicine, University Hospital Bern (Inelspital)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>29492696</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30113379</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28498176</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24401069</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30346242</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25957498</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30665181</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>31921867</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29038450</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11430542</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.</citation>
    <PMID>15817019</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21479777</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8311667</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Virtual Reality</keyword>
  <keyword>Delirium</keyword>
  <keyword>Intensive Care Unit</keyword>
  <keyword>Critical Care</keyword>
  <keyword>Movement Analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators will ask patients to provide informed consent for sharing their anonymized data. Once the study results are published, the investigators will make the de-identified study dataset available for secondary analyses by sharing the dataset upon reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be shared once study results have been published.</ipd_time_frame>
    <ipd_access_criteria>To be determined.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04498585
org study id: KEK2020-00039
secondary id: 2020-00039
nct id: NCT04498585
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of Delirium
time frame: Number of incidences during stay in the intensive care unit (to a maximum of 14 days)
description: 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.
measure: Pattern of the movements before and during delirium
time frame: Recorded during entire stay in the ICU (to a maximum of 14 days)
description: Movement patterns, measured as acceleration and rotation, will be measured using inertial measurement units. The data will be used to determine if there is a change in pattern or intensity between periods before and during delirium.
measure: Intensity of the movements before and during delirium
time frame: Recorded during entire stay in the ICU (to a maximum of 14 days)
description: Movement patterns, measured as acceleration and rotation, will be measured using inertial measurement units. The data will be used to determine if there is a change in intensity between periods before and during delirium.
measure: Duration of Delirium
time frame: Recorded during entire stay in the ICU (to a maximum of 14 days)
description: The duration of delirium will be evaluated per 8 hour periods, or as needed, while patients are in the ICU. If the participant is assessed as delirious during any of the assessments during an 8 hour span, the entire period will count as delirious.
measure: Cognitive Functioning
time frame: Compared between functioning at discharge to 6-months post-discharge.
description: Cognitive abilities will be measured using the Montreal Cognitive Assessment (MoCA).
measure: Health Related Quality of Life
time frame: Compared between quality pre-admission to 6-months post-discharge.
description: Quality of life is examined via the EQ-5D questionnaire (official name, not abbreviated). The five-level version (5L) will be used. The five levels of the scale, scored from 1 to 5 are: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The numbers for the five dimensions are subsequently combined to create a unique 5-digit code which represents the respondent's overall health state. This means an index of 11111 is the best possible health, and 55555 is the worst possible health.
measure: Functional Independence
time frame: Compared between quality pre-admission to 6-months post-discharge.
description: Independence is examined using the Functional Independence Measure (FIM).
measure: Heart Rate
time frame: Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).
description: Changes in heart rate (beats per minute) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.
measure: Blood Pressure
time frame: Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).
description: Changes in blood pressure (mmHg) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.
measure: Respiration Rate
time frame: Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).
description: Changes in respiration rate (breaths per minute) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.
measure: Oxygen Saturation
time frame: Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).
description: Changes in oxygen saturation (%) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.
measure: System Usability Scale
time frame: Once a day for the duration of the patient's time in the ICU (to a maximum of 14 days).
description: The 10-item System Usability Scale is used to collect data on the user's (nurse providing VR stimulation) subjective usability assessments. There are five response options per question; from Strongly disagree (1) to Strongly agree (5). For each odd numbered question, subtract 1 from the score. For each even numbered question, subtract the score from 5. Add up the new values calculated and multiply this total by 2.5. This gives a final score from 0 - 100 (this is not a percentage, but values can be normalized to produce a percentile ranking). A score above 68 is considered above average, and below 68 is below average.
arm group label: Intervention
arm group type: Experimental
description: Participants who will be receiving standard ICU care and additionally the VR stimulation during their ICU stay.
arm group label: Control
arm group type: No Intervention
description: 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.
intervention type: Other
intervention name: VR Stimulation
description: 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.
arm group label: Intervention
other name: Visuo-acoustic stimulation
criteria: 
gender: All
gender based: Yes
gender description: Self identified gender
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthias Hänggi, Dr. med
role: Principal Investigator
affiliation: Department of Intensive Care Medicine, University Hospital Bern (Inelspital)
facility: 
country: Switzerland
citation: 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.
PMID: 29492696
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responsible party type: Sponsor
mesh term: Delirium
sharing ipd: Yes
ipd description: The investigators will ask patients to provide informed consent for sharing their anonymized data. Once the study results are published, the investigators will make the de-identified study dataset available for secondary analyses by sharing the dataset upon reasonable request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be shared once study results have been published.
ipd access criteria: To be determined.