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Recruiting NCT06642636

ICU-VR Prior to ICU Admission

No phase Interventional Post Intensive Care Syndrome (PICS) PTSD - Post Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intensive Care Unit-specific Virtual Reality.
Who it may be relevant to
Registry conditions: Post Intensive Care Syndrome (PICS), PTSD - Post Traumatic Stress Disorder. Basic parameters: 18 years — 71 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Intensive Care Unit-specific Virtual Reality As Preparation for ICU Admission in Lung Transplant Patients

Overview

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.

Interventions

  • 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 applicat

Primary outcome measures

  • 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.]
Secondary outcome measures (2)
  • 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.]

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Netherlands · 1 center
  • Erasmus Medical Center — Rotterdam

Identifiers

NCT: NCT06642636 · NL87675.078.24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗