Virtual Reality on the IMC

Virtual Reality Stimulation on the Intermediate Care Unit

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.

Study Overview

• Status: Completed
• Conditions: Feasibility of Virtual Reality Stimulation for Critically Ill Patients
• Intervention / Treatment: Device: Virtual Reality Stimulation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 1010
    • Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Stimulation; 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; 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.; Other Names: Visuo-acoustic stimulation

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Movement Patterns before and after VR stimulation	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.	Recorded during entire stay in the IMC (up to 24 hours)
Movement Intensity before and after VR stimulation	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.	Recorded during entire stay in the IMC (up to 24 hours)
Cognitive Functioning	Cognitive abilities will be measured using the Montreal Cognitive Assessment (MoCA).	Recorded during entire stay in the IMC (up to 24 hours)

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Virtual Reality; Critical Care; Movement Analysis; Intermediate Care Unit
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: KEK2020-00039b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will ask patients to provide informed consent for sharing their anonymized data. Once the study results are published, the investigators will make the de-identified study dataset available for secondary analyses by sharing the dataset upon reasonable request.
• IPD Sharing Time Frame: Data will be shared once study results have been published.
• IPD Sharing Access Criteria: To be determined.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No