Skip to main content
Clinical Trials/NCT05380700
NCT05380700
Completed
Not Applicable

Virtual Reality Stimulation on the Intermediate Care Unit

Insel Gruppe AG, University Hospital Bern1 site in 1 country40 target enrollmentJanuary 17, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Feasibility of Virtual Reality Stimulation for Critically Ill Patients
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
40
Locations
1
Primary Endpoint
Acceptability of providing virtual reality stimulation
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 17, 2022
End Date
May 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Acceptability of providing virtual reality stimulation

Time Frame: Recorded immediately after every VR 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.

Safety of providing virtual reality stimulation

Time Frame: 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.

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.

Secondary Outcomes

  • Heart Rate(Recorded during entire stay in the IMC (up to 24 hours))
  • Oxygen Saturation(Recorded during entire stay in the IMC (up to 24 hours))
  • Blood Pressure(Recorded during entire stay in the IMC (up to 24 hours))
  • Respiration Rate(Recorded during entire stay in the IMC (up to 24 hours))

Study Sites (1)

Loading locations...

Similar Trials