Virtual Reality to Reduce Delirium
Primary Purpose
Delirium, Cognitive Impairment
Status
Suspended
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
VR Stimulation
Sponsored by
About this trial
This is an interventional prevention trial for Delirium focused on measuring Virtual Reality, Delirium, Intensive Care Unit, Critical Care, Movement Analysis
Eligibility 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
Sites / Locations
- Inselspital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Participants who will be receiving standard ICU care and additionally the VR stimulation during their ICU stay.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pattern of the movements before and during delirium
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.
Intensity of the movements before and during delirium
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.
Duration of Delirium
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.
Full Information
NCT ID
NCT04498585
First Posted
July 28, 2020
Last Updated
February 8, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern
1. Study Identification
Unique Protocol Identification Number
NCT04498585
Brief Title
Virtual Reality to Reduce Delirium
Official Title
Virtual Reality Stimulation to Relax and Reduce the Incidence of Delirium
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
Decreased resources due to COVID-19
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Cognitive Impairment
Keywords
Virtual Reality, Delirium, Intensive Care Unit, Critical Care, Movement Analysis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
920 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants who will be receiving standard ICU care and additionally the VR stimulation during their ICU stay.
Arm Title
Control
Arm Type
No Intervention
Arm 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(s)
VR Stimulation
Other Intervention Name(s)
Visuo-acoustic stimulation
Intervention 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.
Primary Outcome Measure Information:
Title
Incidence of Delirium
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.
Time Frame
Number of incidences during stay in the intensive care unit (to a maximum of 14 days)
Secondary Outcome Measure Information:
Title
Pattern of the movements before and during delirium
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.
Time Frame
Recorded during entire stay in the ICU (to a maximum of 14 days)
Title
Intensity of the movements before and during delirium
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.
Time Frame
Recorded during entire stay in the ICU (to a maximum of 14 days)
Title
Duration of Delirium
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.
Time Frame
Recorded during entire stay in the ICU (to a maximum of 14 days)
Other Pre-specified Outcome Measures:
Title
Cognitive Functioning
Description
Cognitive abilities will be measured using the Montreal Cognitive Assessment (MoCA).
Time Frame
Compared between functioning at discharge to 6-months post-discharge.
Title
Health Related Quality of Life
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.
Time Frame
Compared between quality pre-admission to 6-months post-discharge.
Title
Functional Independence
Description
Independence is examined using the Functional Independence Measure (FIM).
Time Frame
Compared between quality pre-admission to 6-months post-discharge.
Title
Heart Rate
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.
Time Frame
Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).
Title
Blood Pressure
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.
Time Frame
Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).
Title
Respiration Rate
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.
Time Frame
Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).
Title
Oxygen Saturation
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.
Time Frame
Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).
Title
System Usability Scale
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.
Time Frame
Once a day for the duration of the patient's time in the ICU (to a maximum of 14 days).
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Self identified gender
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Hänggi, Dr. med
Organizational Affiliation
Department of Intensive Care Medicine, University Hospital Bern (Inelspital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data will be shared once study results have been published.
IPD Sharing Access Criteria
To be determined.
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Virtual Reality to Reduce Delirium
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