Intensive Care Unit specific Virtual Reality (ICU-VR) to improve psychological impairments in survivors of COVID-19; a multicentre, randomised controlled trial.

Completed

Conditions: COVID-19, anxiety, depression, post-traumatic stress disorder (PTSD)

Registration Number: NL-OMON20934

Lead Sponsor: Erasmus Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

Above 18 years old
- A positive SARS-CoV-2 PCR with clinical signs of COVID-19 necessitating ICU care
- Able to understand the Dutch language
- Signed informed-consent

Exclusion Criteria

- Documented active, established psychiatric disease (for instance personality disorders or schizophrenia)
- Admitted with or a history of primary neurological impairment necessitating ICU admission to or discharge of the ICU (patients admitted with traumatic brain injury, CVA, stroke, meningitis). Patients with a medical history of delirium are eligible, if symptoms of delirium are not present at the time of inclusion.
- Lack of formal home address

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of ICU-VR, given 3 months after hospital discharge, on the severity and prevalence of psychological sequelae, such as PTSD, anxiety and depression, and the health-related quality of life in ICU patients treated for COVID-19 up to 6 months after discharge, assessed using a between-group analysis.

Secondary Outcome Measures

Name	Time	Method
Satisfactions with and rating of ICU care and aftercare, and perspectives on ICU-VR. Additionally, we explored the effect of ICU-VR, given 6 months after hospital discharge, on the severity and prevalence of psychological sequelae, such as PTSD, anxiety and depression, and the health-related quality of life in ICU patients treated for COVID-19 up to 12 months after discharge, assessed using a within-group analysis.