ICU-VR Prior to ICU Admission

NCT06642636 | Recruiting

• 1 other identifier: NL87675.078.24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

virtual reality; extended reality; intensive care; intensive care unit; intensive care units; critical care; lung transplantation; ICU-VR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patients' perspectives and satisfaction with ICU care and the VR intervention

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

• PTSD

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

Study Arms (2)

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.

Device: Intensive Care Unit-specific Virtual Reality

Control

NO INTERVENTION

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

Interventions

Intensive Care Unit-specific Virtual Reality 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).

ICU-VR

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Denzel Drop: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

MeSH Terms

Conditions

postintensive care syndrome; Combat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Denzel LQ Drop, MD

CONTACT

0031629659221; d.drop@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: February 28, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

NL (1)