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Virtual Reality on the IMC

Virtual Reality Stimulation on the Intermediate Care Unit

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05380700
Enrollment
40
Registered
2022-05-19
Start date
2022-01-17
Completion date
2022-05-31
Last updated
2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feasibility of Virtual Reality Stimulation for Critically Ill Patients

Keywords

Virtual Reality, Intermediate Care Unit, Critical Care, Movement Analysis

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.

Interventions

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.

Sponsors

University of Bern
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

All participants receive the intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of providing virtual reality stimulationRecorded immediately after every VR stimulationTo 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 stimulationSafety 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

MeasureTime frameDescription
Blood PressureRecorded 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.
Heart RateRecorded 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.
Respiration RateRecorded 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.
Oxygen SaturationRecorded 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.

Other

MeasureTime frameDescription
Movement Intensity before and after VR stimulationRecorded during entire stay in the IMC (up to 24 hours)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.
Movement Patterns before and after VR stimulationRecorded during entire stay in the IMC (up to 24 hours)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.
Cognitive FunctioningRecorded during entire stay in the IMC (up to 24 hours)Cognitive abilities will be measured using the Montreal Cognitive Assessment (MoCA).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026