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Virtual reality for relatives of ICU patients (ICU-VR-F) to improve psychological sequelae.
NL-OMON; 2021-01-25; TrialID: NL-OMON23834
Clinical Trial Register | ICTRP | ID: ictrp-NL-OMON23834
ABSTRACT

Condition

Post-Intensive Care Syndrome Family (PICS-F), post-traumatic stress disorder, anxiety, depression

Intervention

The ICU-VR-F module was adapted to a prior designed patient VR module to match the need of relatives. The current VR module was designed with the aim to show relatives relevant and truthful information regarding their ICU treatment. The point of view for the camera was the field of vision of the mock patient lying in a hospital bed. Based on focus group meetings and previous studies, the following information was included in the module 1) an introduction by an intensivist and an ICU nurse to welcome the patient to the ICU and VR environment explaining daily movements at an ICU, 2) explanation of monitors and noises in an ICU room, 3) information regarding mechanical ventilation, intubation and tracheal tube suction, 4) necessity of central/peripheral lines and IV/drips, 5) information and necessity of the treatment team and ICU workflow.
After randomization, participants in the intervention group will receive ICU-VR using head-mounted display VR (Oculus Go, Irvine, CA, CE R-CMM-OC8-MH-A), followed by the possibility to watch the ICU-VR-F module again whenever desirable via cardboard VR glasses through an access link. The number of sessions via the cardboard VR glasses will be noted. Participants who are not allowed to visit the hospital due to COVID-19 regulations, i.e., mandatory self-quarantine, inability to visit the ICU, or a limited number of visitors, will only receive ICU-VR-R using cardboard VR glasses.

Primary 

outcome:

The primary endpoint is the effect of ICU-VR-F on PTSD, anxiety, depression, and quality of life in relatives of ICU patients up to six months after ICU discharge. PTSD will be assessed using the impact of event scale-revised (IES-R), anxiety and depression using the hospital anxiety and depression scale (HADS), and quality of life using the RAND-36.

Criteria

Inclusion criteria • =18 years old
• First/second degree relatives (spouses, sibling, parent, children), responsible for decision making, sharing the same household (in absence of next of kin), or close friend (in absence of other relatives)
• Able to understand the Dutch language
• In possession of a smartphone/tablet compatible to watch ICU-VR-F at home
• Signed informed-consent

Exclusion criteria • Lack of a formal home address
Family members of patients with an ICU-LOS <72 hours
Relatives of patients who decease during ICU treatment will retrospectively be excluded from the main

analysis:

Collection: Clinical trial registers Database: ICTRP Topics: Long Covid Year: 2021 Document Type: Clinical Trial Register

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Collection: Clinical trial registers Database: ICTRP Topics: Long Covid Year: 2021 Document Type: Clinical Trial Register