Ireland
--:--IST
Recruiting Not applicable

ICU-VR Prior to ICU Admission

NCT06642636 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Denzel Drop
Phase
Not applicable
Started
2025-02-28
Last updated
2025-03-04

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Intensive Care Unit-specific Virtual Reality

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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
71 Years
Healthy volunteers
No
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 Exclusion Criteria: 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.

Primary outcome measure(s)

  • Percieved quality of information provision — 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.

Trial sites (1)

FacilityCityRegionStatus
Erasmus Medical Center Rotterdam South Holland Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06642636 on ClinicalTrials.gov ↗ ← All trials in the Netherlands