Post Intensive Care Syndrome (PICS)NCT06642636
ICU-VR Prior to ICU Admission
A study testing Intensive Care Unit-specific Virtual Reality in people with Post Intensive Care Syndrome (PICS) and PTSD - Post Traumatic Stress Disorder, run by Denzel Drop at 1 site in Netherlands.
Trial summary
Rationale: A substantial proportion of the Intensive Care Unit (ICU) survivors develop psychological impairments due to their ICU admission. Several interventions to mitigate these impairments have been explored but lack a proper effect. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Post Intensive Care Syndrome (PICS), PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Intensive Care Unit-specific Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Be on the waiting list for lung transplantation
- Age 18-71 years (maximum age for lung transplantation is 71 years)
- Understand the Dutch language
- Signed informed consent
Who cannot join
- While patients on the waiting list for lung transplantation are intensively monitored and only placed on the waiting list under strict conditions, no additional exclusion criteria above these are identified to exclude specific patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Denzel LQ Drop, MD, 0031629659221, d.drop@erasmusmc.nl
About this study
Official title: Intensive Care Unit-specific Virtual Reality As Preparation for ICU Admission in Lung Transplant Patients
Rationale: A substantial proportion of the Intensive Care Unit (ICU) survivors develop psychological impairments due to their ICU admission. Several interventions to mitigate these impairments have been explored but lack a proper effect. Intensive Care Unit-specific Virtual Reality has proven to be potentially effective in treating PTSD and depression-related sequelae in ICU-survivors.
Objective: To evaluate the contribution in terms of information provision and patients' perspectives of ICU-VR to prepare lung transplant patients for their future ICU admission
Read more
Study design: A monocentre randomized controlled study
Study population: Lung transplant patients who are on the waiting list and understand the Dutch language. Due to the criteria for lung transplantation, these are 18-71 years of age. Participants need to have signed the informed consent formular.
Intervention: The ICU-VR intervention is designed by an interdisciplinary team of intensivists, ICU nurses, a psychiatrist, a psychologist, and a former ICU patient, to expose patients to the ICU environment while offering treatment- and department-related information. During the 12-minute lasting intervention, patients experience different facets of ICU treatment and receive information on the ICU environment, treatment, and workflow. The intervention group will receive this treatment during the appointment with the lung transplantation nurse. The control group will receive the regular hospital preparation care.
Primary endpoints: The primary endpoint will be the difference in information provision of the ICU care of lung transplant patients on the waiting list.
- Being tested
- Intensive Care Unit-specific Virtual Reality
- Keywords
- virtual reality, extended reality, intensive care, intensive care unit, intensive care units, critical care, lung transplantation, ICU-VR
- Medical subject headings
- postintensive care syndrome, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Care Unit-specific Virtual RealityDevice
The Intensive Care specific Virtual Reality (ICU-VR) film is designed so that patients received relevant and truthful information regarding their ICU treatment with the aim to reduce stress and anxiety. The final film lasts approximately 12 minutes. Real ICU nurses and ICU physicians re-enacting a typical day/treatment for a mock patient undergoing ICU treatment. The module will be watched via HMD-VR glasses (PICO G2 VR; Pico Technology, Beijing, China) with the SyncVR Relax \& Distract application (SyncVR, Utrecht, the Netherlands).
| Study group | Role | What they receive |
|---|---|---|
| ICU-VR | Experimental | Regarding the participants in the intervention group, an appointment will be scheduled with a nurse specialist of the department of pulmonology and a researcher to watch the ICU-VR intervention. During this appointment, patients will be allowed to watch the VR video as many times as desired. Receives: Device: Intensive Care Unit-specific Virtual Reality |
| Control | No intervention | The control group will receive the usual care and no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percieved quality of information provision
The primary endpoint will be the difference in the patients' perceived quality of information provision during preparation of the future planned ICU admission between the intervention and control group, measured after ICU admission. This will be assessed using a subset of the Consumer Quality Index-Relatives ICU (CQI-Relatives ICU), carefully tailored to the needs of this study by members of the RATE-XR steering group and currently being used in another randomized controlled trial investigating the effect of ICU-VR on information provision in relatives of ICU patients. The CQI-Relatives ICU was designed according to a robust method developed by the Healthcare Institute of the Netherlands.
Measured: Participants will be followed from inclusion until two weeks after ICU admission, when they complete the last questionnaires.
Secondary outcomes (2)
Patients' perspectives and satisfaction with ICU care and the VR intervention
Patients' perspectives and satisfaction towards the ICU-VR intervention (only in the intervention group) and perspectives and satisfaction towards the preparation for ICU admission, the delivered ICU care, and the ICU aftercare. This will be measured two weeks after the VR session and two weeks after an ICU discharge using a questionnaire, which was based on the Patient Satisfaction Questionnaire and Family Satisfaction with ICU Care tools. This questionnaire is carefully tailored to the needs of the study, in which we also added some items to evaluate patients' perspectives on the ICU-VR intervention. This questionnaire was previously used in another RCT to evaluate the effect of ICU-VR in post-ICU patients and is currently being used in our HORIZON-IC study (as mentioned in the introduction and rationale)
Measured: Participants will be followed from inclusion until two weeks after ICU admission, when they complete the last questionnaires.
PTSD
The severity of PTSD-related symptoms will be expressed as the sum score of the Impact of Event Scale - Revised (IES-R) and the prevalence of probable PTSD will be expressed as the proportion of patients having an IES-R sum score above 23. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It is a revised version of the older version, the 15-item IES. The IES-R contains seven additional items related to the hyperarousal symptoms of PTSD, which are not included in the original IES. Items are rated on a 5-point scale ranging from 0 ('not at al') to 4 ('extremely'). The IES-R yields a total score (ranging from 0 to 88; higher scores indicate more severe symptoms), and subscale scores can also be calculated for the Intrusion, Avoidance and Hyperarousal subscales. The severity and prevalence of PTSD will be assessed two weeks after an ICU discharge.
Measured: Participants will be followed from inclusion until two weeks after ICU admission, when they complete the last questionnaires.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start28 Feb 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care Syndrome (PICS)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Denzel Drop
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Denzel Drop, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642636
- Sponsor's protocol ID
- NL87675.078.24
- Status last verified
- Feb 2025
- First submitted
- 10 Oct 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Unit-specific Virtual Reality As Preparation for ICU Admission in Lung Transplant Patients
- ClinicalTrials.gov ID
- NCT06642636
- Acronym / sponsor ID
- NL87675.078.24
- Keywords
- virtual reality, extended reality, intensive care, intensive care unit, intensive care units, critical care, lung transplantation, ICU-VR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Denzel DropUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
Rationale: A substantial proportion of the Intensive Care Unit (ICU) survivors develop psychological impairments due to their ICU admission. Several interventions to mitigate these impairments have been explored but lack a proper effect. Intensive Care Unit-specific Virtual Reality has proven to be potentially effective in treating PTSD and depression-related sequelae in ICU-survivors.
Objective: To evaluate the contribution in terms of information provision and patients' perspectives of ICU-VR to prepare lung transplant patients for their future ICU admission
Study design: A monocentre randomized controlled study
Study population: Lung transplant patients who are on the waiting list and understand the Dutch language. Due to the criteria for lung transplantation, these are 18-71 years of age. Participants need to have signed the informed consent formular.
Intervention: The ICU-VR intervention is designed by an interdisciplinary team of intensivists, ICU nurses, a psychiatrist, a psychologist, and a former ICU patient, to expose patients to the ICU environment while offering treatment- and department-related information. During the 12-minute lasting intervention, patients experience different facets of ICU treatment and receive information on the ICU environment, treatment, and workflow. The intervention group will receive this treatment during the appointment with the lung transplantation nurse. The control group will receive the regular hospital preparation care.
Primary endpoints: The primary endpoint will be the difference in information provision of the ICU care of lung transplant patients on the waiting list.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU-VR | Experimental | Device: Intensive Care Unit-specific Virtual RealityRegarding the participants in the intervention group, an appointment will be scheduled with a nurse specialist of the department of pulmonology and a researcher to watch the ICU-VR intervention. During this appointment, patients will be allowed to watch the VR video as many times as desired. |
| Control | No intervention | –The control group will receive the usual care and no intervention. |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Be on the waiting list for lung transplantation
- Age 18-71 years (maximum age for lung transplantation is 71 years)
- Understand the Dutch language
- Signed informed consent
Key exclusion criteria (1 listed)
- While patients on the waiting list for lung transplantation are intensively monitored and only placed on the waiting list under strict conditions, no additional exclusion criteria above these are identified to exclude specific patients.
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 |
|---|---|---|
| Intensive Care Unit-specific Virtual RealityThe Intensive Care specific Virtual Reality (ICU-VR) film is designed so that patients received relevant and truthful information regarding their ICU treatment with the aim to reduce stress and anxiety. The final film lasts approximately 12 minutes. Real ICU nurses and ICU physicians re-enacting a typical day/treatment for a mock patient undergoing ICU treatment. The module will be watched via HMD-VR glasses (PICO G2 VR; Pico Technology, Beijing, China) with the SyncVR Relax \& Distract application (SyncVR, Utrecht, the Netherlands). | Device | ICU-VR |
Primary outcome
Percieved quality of information provision
Time frame: Participants will be followed from inclusion until two weeks after ICU admission, when they complete the last questionnaires.
The primary endpoint will be the difference in the patients' perceived quality of information provision during preparation of the future planned ICU admission between the intervention and control group, measured after ICU admission. This will be assessed using a subset of the Consumer Quality Index-Relatives ICU (CQI-Relatives ICU), carefully tailored to the needs of this study by members of the RATE-XR steering group and currently being used in another randomized controlled trial investigating the effect of ICU-VR on information provision in relatives of ICU patients. The CQI-Relatives ICU was designed according to a robust method developed by the Healthcare Institute of the Netherlands.
2 secondary outcomes
Patients' perspectives and satisfaction with ICU care and the VR intervention
Time frame: Participants will be followed from inclusion until two weeks after ICU admission, when they complete the last questionnaires.
PTSD
Time frame: Participants will be followed from inclusion until two weeks after ICU admission, when they complete the last questionnaires.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Care Unit-specific Virtual Reality in people with Post Intensive Care Syndrome (PICS) and PTSD - Post Traumatic Stress Disorder, run by Denzel Drop at 1 site in Netherlands.
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 1 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: looking for participants now, as of the sponsor's last update on 4 Mar 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denzel LQ Drop, MD (0031629659221, d.drop@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percieved quality of information provision (time frame: Participants will be followed from inclusion until two weeks after ICU admission, when they complete the last questionnaires.). 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 4 Mar 2025.