Cognitive Impairment, Delirium
Conditions
Keywords
Virtual Reality, Delirium, Intensive Care Unit, Critical Care, Movement Analysis
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.
Interventions
OTHERVR 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.
Sponsors
University of Bern
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Delirium | 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
| Measure | Time frame | Description |
|---|---|---|
| Pattern of the movements before and during delirium | 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. |
| Intensity of the movements before and during delirium | 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. |
| Duration of Delirium | 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
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 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. |
| Respiration Rate | 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. |
| Cognitive Functioning | Compared between functioning at discharge to 6-months post-discharge. | Cognitive abilities will be measured using the Montreal Cognitive Assessment (MoCA). |
| System Usability Scale | 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. |
| Oxygen Saturation | 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. |
| Health Related Quality of Life | 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. |
| Functional Independence | Compared between quality pre-admission to 6-months post-discharge. | Independence is examined using the Functional Independence Measure (FIM). |
| Heart Rate | 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. |
Countries
Switzerland
Outcome results
None listed