Virtual Reality on the IMC

NCT05380700 | Completed DMC

• 1 other identifier: KEK2020-00039b
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Feasibility of Virtual Reality Stimulation for Critically Ill Patients

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Heart Rate

  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)

• Oxygen Saturation

  Recorded during entire stay in the IMC (up to 24 hours)

Other Outcomes (3)

• Movement Patterns before and after VR stimulation

  Recorded during entire stay in the IMC (up to 24 hours)

• Movement Intensity before and after VR stimulation

  Recorded during entire stay in the IMC (up to 24 hours)

• Cognitive Functioning

  Recorded during entire stay in the IMC (up to 24 hours)

Study Arms (1)

Virtual Reality Stimulation

EXPERIMENTAL

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

Interventions

Virtual Reality Stimulation DEVICE

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.

Also known as: Visuo-acoustic stimulation

Virtual Reality Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Aged ≥18 years
• No severe visual or auditory impairments (strabismus, macular degeneration, retinopathy)
• German or French speaking

You may not qualify if:

• Patients without calotte, with external ventricular drainage or other Intracranial pressure probes
• Patients with epilepsy
• Patients with Covid-19

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Inselspital

Bern, 1010, Switzerland

Location

Study Officials

• Matthias Hänggi, Dr. med

  Department of Intensive Care Medicine, University Hospital Bern (Inelspital)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants receive the intervention

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: May 19, 2022
• Study Start: January 17, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Data will be shared once study results have been published.
• Access Criteria: To be determined.

Locations

CH (1)