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Virtual Reality on the IMC

Primary Purpose

Feasibility of Virtual Reality Stimulation for Critically Ill Patients

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Virtual Reality Stimulation
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Feasibility of Virtual Reality Stimulation for Critically Ill Patients focused on measuring Virtual Reality, Intermediate Care Unit, Critical Care, Movement Analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inselspital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Reality Stimulation

Arm Description

All participants will be receiving the standard care and additionally the VR stimulation during their stay in the intermediate care unit.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 21, 2022
Last Updated
June 16, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT05380700
Brief Title
Virtual Reality on the IMC
Official Title
Virtual Reality Stimulation on the Intermediate Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feasibility of Virtual Reality Stimulation for Critically Ill Patients
Keywords
Virtual Reality, Intermediate Care Unit, Critical Care, Movement Analysis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants receive the intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Stimulation
Arm Type
Experimental
Arm Description
All participants will be receiving the standard care and additionally the VR stimulation during their stay in the intermediate care unit.
Intervention Type
Device
Intervention Name(s)
Virtual Reality Stimulation
Other Intervention Name(s)
Visuo-acoustic stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of providing virtual reality stimulation
Description
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.
Time Frame
Recorded immediately after every VR stimulation
Title
Safety of providing virtual reality stimulation
Description
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.
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.
Secondary Outcome Measure Information:
Title
Heart Rate
Description
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.
Time Frame
Recorded during entire stay in the IMC (up to 24 hours)
Title
Blood Pressure
Description
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.
Time Frame
Recorded during entire stay in the IMC (up to 24 hours)
Title
Respiration Rate
Description
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.
Time Frame
Recorded during entire stay in the IMC (up to 24 hours)
Title
Oxygen Saturation
Description
Changes in oxygen saturation (%) recorded from the patient will be compared from the start of the stimulation to the end of the stimulation period.
Time Frame
Recorded during entire stay in the IMC (up to 24 hours)
Other Pre-specified Outcome Measures:
Title
Movement Patterns before and after VR stimulation
Description
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.
Time Frame
Recorded during entire stay in the IMC (up to 24 hours)
Title
Movement Intensity before and after VR stimulation
Description
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.
Time Frame
Recorded during entire stay in the IMC (up to 24 hours)
Title
Cognitive Functioning
Description
Cognitive abilities will be measured using the Montreal Cognitive Assessment (MoCA).
Time Frame
Recorded during entire stay in the IMC (up to 24 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Hänggi, Dr. med
Organizational Affiliation
Department of Intensive Care Medicine, University Hospital Bern (Inelspital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
1010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Virtual Reality on the IMC

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