Virtual Reality on the IMC

Study Overview
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Brief Summary
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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.

Official Title
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Virtual Reality Stimulation on the Intermediate Care Unit

Conditions
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Feasibility of Virtual Reality Stimulation for Critically Ill Patients

Intervention / Treatment
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* Device: Virtual Reality Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Aged ≥18 years No severe visual or auditory impairments (strabismus, macular degeneration, retinopathy) German or French speaking Estimated length of stay (from time of study inclusion) >24 hours Exclusion Criteria: Patients without calotte, with external ventricular drainage or other Intracranial pressure probes Patients with epilepsy Patients with Covid-19

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: All participants receive the intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Stimulation<br>All participants will be receiving the standard care and additionally the VR stimulation during their stay in the intermediate care unit. | Device: Virtual Reality Stimulation<br>* 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.<br>* Other names: Visuo-acoustic stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Intermediate Care Unit, Critical Care, Movement Analysis