Clinical trial NCT05380700: Virtual Reality on the IMC
Official title: Virtual Reality Stimulation on the Intermediate Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility of Virtual Reality Stimulation for Critically Ill Patients
Keywords: Virtual Reality
Intermediate Care Unit
Critical Care
Movement Analysis
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2022-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive the intervention
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of providing virtual reality stimulation
timeFrame: Recorded immediately after every VR stimulation
measure: Safety of providing virtual reality stimulation
timeFrame: 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 outcomes:
measure: Heart Rate
timeFrame: Recorded during entire stay in the IMC (up to 24 hours)
measure: Blood Pressure
timeFrame: Recorded during entire stay in the IMC (up to 24 hours)
measure: Respiration Rate
timeFrame: Recorded during entire stay in the IMC (up to 24 hours)
measure: Oxygen Saturation
timeFrame: Recorded during entire stay in the IMC (up to 24 hours)
Other outcomes:
measure: Movement Patterns before and after VR stimulation
timeFrame: Recorded during entire stay in the IMC (up to 24 hours)
measure: Movement Intensity before and after VR stimulation
timeFrame: Recorded during entire stay in the IMC (up to 24 hours)
measure: Cognitive Functioning
timeFrame: Recorded during entire stay in the IMC (up to 24 hours)
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Department of Intensive Care Medicine, University Hospital Bern (Inelspital)
name: Matthias Hänggi, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: