ICU-VR Prior to ICU Admission

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

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 Overview

• Status: Recruiting
• Conditions: Post Intensive Care Syndrome (PICS); PTSD - Post Traumatic Stress Disorder
• Intervention / Treatment: Device: Intensive Care Unit-specific Virtual Reality

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denzel LQ Drop, MD; Phone Number: 0031629659221; Email: d.drop@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus Medical Center
      • Contact: Denzel LQ Drop, MD; Phone Number: 0031629659221; Email: d.drop@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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).
No Intervention: Control; The control group will receive the usual care and no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Participants will be followed from inclusion until two weeks after ICU admission, when they complete the last questionnaires.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Participants will be followed from inclusion until two weeks after ICU admission, when they complete the last questionnaires.

Collaborators and Investigators

• Sponsor: Denzel Drop

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: intensive care unit; critical care; intensive care; virtual reality; intensive care units; lung transplantation; extended reality; ICU-VR
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: NL87675.078.24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No