Intensive Care Unit specific Virtual Reality for family members (ICU-VR-F) of patients in the ICU.

An Intensive Care Unit (ICU) admission of a family member can lead to anxiety,
depression, and induce post-traumatic stress disorder (PTSD) and complicated
grief in family members due to the unknown and often unexpected situation and
worries about the critically ill patient. The inability to visit patients in
the ICU during the COVID-19 pandemic is expected to further increase this risk.
These impairments are part of the so-called Post-Intensive Care Syndrome Family
(PICS-F). To date, there is a lack of effective interventions to ameliorate
PICS-F, although provision of information may be of added value. In the current
trial, we hypothesized that information provision using an Intensive Care Unit
specific Virtual Reality intervention for Family members (ICU-VR-F) can improve
understanding of the ICU and subsequently reduces psychological distress and
improves health-related quality of life (HRQoL) in family members of patients
admitted to the ICU.

Our primary objective is to determine the effect of ICU-VR-F on symptoms of
depression, anxiety and PTSD, and the health-related quality of life (HRQoL) in
family members of ICU patients. The secondary objective is to determine the
effect of ICU-VR-F on the understanding of and satisfaction with ICU care.

A multicentre, clustered randomized trial conducted in one academic and three
teaching hospitals in Rotterdam, the Netherlands.

Family members will be randomized, based on the patient that is admitted, into
two study groups, multiple family members per patient can be included and will
be allocated clustered to the same randomization group. Family members in the
intervention group who are allowed to visit the hospital will receive ICU-VR-F
the first time in the hospital. Furthermore, the intervention group will
receive Intensive Care Unit specific Virtual Reality for Family (ICU-VR-F), a
15-minute lasting information video that can be watched using Virtual Reality
or 2D, using an access link and cardboard VR glasses. The control group will
receive care as usual.

No additional burden is expected. ICU-VR, the patient version of ICU-VR-F, was
previously tested safe in healthy volunteers and sepsis survivors and is
currently used in a trial in survivors of COVID-19. No safety issues or adverse
events have been reported using ICU specific VR content nor in other studies
using VR of an informational video. Patients are asked to fill out
questionnaire for a total of four times.