ICU-VR Prior to ICU Admission

NCT ID: NCT06642636

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Post Intensive Care Syndrome (PICS); PTSD - Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ICU-VR

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.

Group Type: EXPERIMENTAL

Intensive Care Unit-specific Virtual Reality

Intervention Type: DEVICE

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).

Control

The control group will receive the usual care and no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intensive Care Unit-specific Virtual Reality

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 71 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Denzel Drop

OTHER

Sponsor Role: lead

Responsible Party

Denzel Drop

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Denzel LQ Drop, MD

Role: CONTACT

d.drop@erasmusmc.nl

0031629659221

Facility Contacts

Denzel LQ Drop, MD

Role: primary

d.drop@erasmusmc.nl

0031629659221

Other Identifiers

NL87675.078.24

Identifier Type: -

Identifier Source: org_study_id