Virtual Reality on the IMC

NCT ID: NCT05380700

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-17

Study Completion Date

2022-05-31

Brief Summary

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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

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Conditions

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Feasibility of Virtual Reality Stimulation for Critically Ill Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants receive the intervention
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Virtual Reality Stimulation

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

Group Type EXPERIMENTAL

Virtual Reality Stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Visuo-acoustic stimulation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bern

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Hänggi, Dr. med

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Inselspital

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK2020-00039b

Identifier Type: -

Identifier Source: org_study_id

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