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Virtual Reality to Reduce Delirium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04498585
Recruitment Status : Not yet recruiting
First Posted : August 4, 2020
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment Phase
Delirium Cognitive Impairment Other: VR Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 920 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Virtual Reality Stimulation to Relax and Reduce the Incidence of Delirium
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Intervention
Participants who will be receiving standard ICU care and additionally the VR stimulation during their ICU stay.
Other: 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 Name: Visuo-acoustic stimulation

No Intervention: 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.



Primary Outcome Measures :
  1. Incidence of Delirium [ Time Frame: Number of incidences during stay in the intensive care unit (to a maximum of 14 days) ]
    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.


Secondary Outcome Measures :
  1. Pattern of the movements before and during delirium [ Time Frame: Recorded during entire stay in the ICU (to a maximum of 14 days) ]
    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.

  2. Intensity of the movements before and during delirium [ Time Frame: Recorded during entire stay in the ICU (to a maximum of 14 days) ]
    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.

  3. Duration of Delirium [ Time Frame: Recorded during entire stay in the ICU (to a maximum of 14 days) ]
    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.


Other Outcome Measures:
  1. Cognitive Functioning [ Time Frame: Compared between functioning at discharge to 6-months post-discharge. ]
    Cognitive abilities will be measured using the Montreal Cognitive Assessment (MoCA).

  2. Health Related Quality of Life [ Time Frame: Compared between quality pre-admission to 6-months post-discharge. ]
    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.

  3. Functional Independence [ Time Frame: Compared between quality pre-admission to 6-months post-discharge. ]
    Independence is examined using the Functional Independence Measure (FIM).

  4. Heart Rate [ Time Frame: Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days). ]
    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.

  5. Blood Pressure [ Time Frame: Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days). ]
    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.

  6. Respiration Rate [ Time Frame: Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days). ]
    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.

  7. Oxygen Saturation [ Time Frame: Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days). ]
    Changes in oxygen saturation (%) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.

  8. 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). ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self identified gender
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498585


Contacts
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Contact: Marie-Madlen Jeitziner, RN, PhD + 41 (0)31 632 19 53 Marie-Madlen.Jeitziner@insel.ch
Contact: Aileen Naef, MSc +41 31 664 08 16 aileen.naef@artorg.unibe.ch

Locations
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Switzerland
Inselspital
Bern, Switzerland, 3010
Contact: Marie-Madlen Jeitziner, PhD    +41 31 632 19 53    Marie-Madlen.Jeitziner@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
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Principal Investigator: Matthias Hänggi, Dr. med Department of Intensive Care Medicine, University Hospital Bern (Inelspital)
Publications:

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04498585    
Other Study ID Numbers: KEK2020-00039
2020-00039 ( Other Identifier: Ethics Committee of the Canton of Bern )
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be shared once study results have been published.
Access Criteria: To be determined.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Virtual Reality
Delirium
Intensive Care Unit
Critical Care
Movement Analysis
Additional relevant MeSH terms:
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Delirium
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases