Feasibility of Virtual Reality Stimulation for Critically Ill PatientsNCT05380700
Virtual Reality on the IMC
A study testing Virtual Reality Stimulation in people with Feasibility of Virtual Reality Stimulation for Critically Ill Patients, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Feasibility of Virtual Reality Stimulation for Critically Ill Patients
- What is being tested?
- Virtual Reality Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Jan 2022to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients without calotte, with external ventricular drainage or other Intracranial pressure probes
- Patients with epilepsy
- Patients with Covid-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Virtual Reality Stimulation
- Keywords
- Virtual Reality, Intermediate Care Unit, Critical Care, Movement Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality StimulationDevice
Also called Visuo-acoustic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Recorded during entire stay in the IMC (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start17 Jan 2022
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility of Virtual Reality Stimulation for Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the intervention
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Matthias Hänggi, Dr. med, Principal investigator, Department of Intensive Care Medicine, University Hospital Bern (Inelspital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380700
- Sponsor's protocol ID
- KEK2020-00039b
- Status last verified
- Jun 2022
- First submitted
- 21 Feb 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Stimulation on the Intermediate Care Unit
- ClinicalTrials.gov ID
- NCT05380700
- Acronym / sponsor ID
- KEK2020-00039b
- Keywords
- Virtual Reality, Intermediate Care Unit, Critical Care, Movement Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the intervention
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Stimulation | Experimental | Device: Virtual Reality StimulationAll participants will be receiving the standard care and additionally the VR stimulation during their stay in the intermediate care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patients without calotte, with external ventricular drainage or other Intracranial pressure probes
- Patients with epilepsy
- Patients with Covid-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality StimulationAlso: Visuo-acoustic stimulationParticipants 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. | Device | Virtual Reality Stimulation |
Primary outcome
Acceptability of providing virtual reality stimulation
Time frame: Recorded immediately after every VR 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
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.
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.
4 secondary outcomes
Heart Rate
Time frame: Recorded during entire stay in the IMC (up to 24 hours)
Blood Pressure
Time frame: Recorded during entire stay in the IMC (up to 24 hours)
Respiration Rate
Time frame: Recorded during entire stay in the IMC (up to 24 hours)
Oxygen Saturation
Time frame: Recorded during entire stay in the IMC (up to 24 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Hänggi, Dr. med principal investigator
Department of Intensive Care Medicine, University Hospital Bern (Inelspital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Stimulation in people with Feasibility of Virtual Reality Stimulation for Critically Ill Patients, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of providing virtual reality stimulation (time frame: Recorded immediately after every VR stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022; AzTrials last refreshed its copy on 3 Nov 2026.