Virtual Reality on the IMC
- Conditions
- Feasibility of Virtual Reality Stimulation for Critically Ill Patients
- Interventions
- Device: Virtual Reality Stimulation
- Registration Number
- NCT05380700
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- Patients without calotte, with external ventricular drainage or other Intracranial pressure probes
- Patients with epilepsy
- Patients with Covid-19
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Virtual Reality Stimulation Virtual Reality Stimulation All participants will be receiving the standard care and additionally the VR stimulation during their stay in the intermediate care unit.
- Primary Outcome Measures
Name Time Method Acceptability of providing virtual reality stimulation 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 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 Outcome Measures
Name Time Method Heart Rate Recorded during entire stay in the IMC (up to 24 hours) 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.
Oxygen Saturation Recorded during entire stay in the IMC (up to 24 hours) Changes in oxygen saturation (%) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.
Blood Pressure Recorded during entire stay in the IMC (up to 24 hours) 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.
Respiration Rate Recorded during entire stay in the IMC (up to 24 hours) 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.
Trial Locations
- Locations (1)
Inselspital
🇨🇭Bern, Switzerland