Clinical trial NCT06642636: ICU-VR Prior to ICU Admission
Official title: Intensive Care Unit-specific Virtual Reality As Preparation for ICU Admission in Lung Transplant Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percieved quality of information provision
timeFrame: Participants will be followed from inclusion until two weeks after ICU admission, when they complete the last questionnaires.
Secondary outcomes:
measure: Patients' perspectives and satisfaction with ICU care and the VR intervention
timeFrame: Participants will be followed from inclusion until two weeks after ICU admission, when they complete the last questionnaires.
measure: PTSD
timeFrame: Participants will be followed from inclusion until two weeks after ICU admission, when they complete the last questionnaires.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
References: