An interventional study of VR Stimulation in Delirium and Cognitive Impairment, sponsored by Insel Gruppe AG, University Hospital Bern. Suspended at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Prevention
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.
1,071 studies on the registry are indexed under Delirium; 239 are open to participants now.
This study's planned enrollment of 920 is above the median of 119 across 608 interventional studies indexed under Delirium.
Browse Delirium studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 737 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Participants who will be receiving standard ICU care and additionally the VR stimulation during their ICU stay.
Other: VR Stimulation
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.
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
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.
Time frame: Number of incidences during stay in the intensive care unit (to a maximum of 14 days)
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.
Time frame: Recorded during entire stay in the ICU (to a maximum of 14 days)
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.
Time frame: Recorded during entire stay in the ICU (to a maximum of 14 days)
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.
Time frame: Recorded during entire stay in the ICU (to a maximum of 14 days)
Cognitive Functioning
Cognitive abilities will be measured using the Montreal Cognitive Assessment (MoCA).
Time frame: Compared between functioning at discharge to 6-months post-discharge.
Health Related Quality of Life
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.
Functional Independence
Independence is examined using the Functional Independence Measure (FIM).
Time frame: Compared between quality pre-admission to 6-months post-discharge.
Heart Rate
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).
Blood Pressure
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).
Respiration Rate
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).
Oxygen Saturation
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).
System Usability Scale
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).
Plan to share: Yes — 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 information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: Data will be shared once study results have been published.
Access criteria: To be determined.
This study is suspended, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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