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| Name | Class |
|---|---|
| University of Bern | OTHER |
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The goal of this substudy (main study NCT04498585) is to determine the feasibility of applying virtual reality stimulation to patients in the intermediate care unit. Patients on this ward are generally more awake and alert than patients in the intensive care unit, thereby they are able to provide feedback about their experience. As the intermediate care unit is not without stress, examining the physiological parameters (e.g., heart rate, respiration rate, blood pressure, etc.) could also provide telling information as to the calming effect of virtual reality. The movements of these patients are also recorded using accelerometers which will provide valuable information about the characteristics of the movements that patients make while confined to their beds. These movements can act as a reference for further investigation into movements related to delirium which is a secondary outcome measure of the main study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Stimulation | Experimental | All participants will be receiving the standard care and additionally the VR stimulation during their stay in the intermediate care unit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Stimulation | Device | Participants in the intervention group will be provided with up to 30 minutes of relaxing, 360-degree virtual reality (VR) stimulation and corresponding sounds, twice in 24 hours during their stay on the intermediate care unit. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of providing virtual reality stimulation | To determine the acceptability of providing VR stimulation to patients in the intermediate care (IMC) unit based on 1) the subjective perception of the feedback, and 2) the ability of the stimulation to be maintained for minimum 20 minutes. | Recorded immediately after every VR stimulation |
| Safety of providing virtual reality stimulation | To determine the safety based on the adverse or serious adverse events reported by the medical staff, or the subjective reporting of the participant who received the VR stimulation. | Safety will be determined based on the reporting of adverse or serious adverse events in the 1-hour following the completion of the VR stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Recorded during entire stay in the IMC (up to 24 hours) |
| Blood Pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Patterns before and after VR stimulation | 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 between periods before, during, or after stimulation. | Recorded during entire stay in the IMC (up to 24 hours) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Hänggi, Dr. med | Department of Intensive Care Medicine, University Hospital Bern (Inelspital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital | Bern | 1010 | Switzerland |
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.
Data will be shared once study results have been published.
To be determined.
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All participants receive the intervention
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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.
| Recorded during entire stay in the IMC (up to 24 hours) |
| 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. | Recorded during entire stay in the IMC (up to 24 hours) |
| 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. | Recorded during entire stay in the IMC (up to 24 hours) |
| Movement Intensity before and after VR stimulation |
Movement intensity, 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, during, or after stimulation. |
| Recorded during entire stay in the IMC (up to 24 hours) |
| Cognitive Functioning | Cognitive abilities will be measured using the Montreal Cognitive Assessment (MoCA). | Recorded during entire stay in the IMC (up to 24 hours) |