The HORIZON-IC study:The effect of Intensive Care Unit-specific Virtual Reality (ICU-VR) on mental health and health-related quality of life in critical illness survivors.

Recruiting

Conditions: Post-Intensive Care Syndrome, Post-Traumatic Stress Disorder, Anxiety, Depression

Registration Number: NL-OMON28097

Lead Sponsor: Erasmus MC, Rotterdam, the Netherlands & Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands

Brief Summary: Safety in healthy volunteers: https://journals.lww.com/ccejournal/Fulltext/2021/05000/Virtual_Reality_Tailored_to_the_Needs_of_Post_ICU.7.aspx ICU-VR in sepsis survivors: https://journals.lww.com/ccejournal/Fulltext/2021/09000/Virtual_Reality_to_Improve_Sequelae_of_the.20.aspx ICU-VR in COVID-19 survivors: Protocol: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05271-z Case-report: https://www.frontiersin.org/articles/10.3389/fmed.2020.629086/full

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

=18 years old
- ICU-Length of stay =72 hours
- Mechanical ventilation =24 hours
- Able to read and speak in the Dutch language
- Signed informed-consent

Exclusion Criteria

- Documented active, established psychiatric disease (for instance personality disorders, posttraumatic stress disorder, schizophrenia, severe depression). Patients who have suffered from psychiatric diseases in the past can participate.
- A history or a primary neurological impairment necessitating ICU treatment (patients admitted with traumatic brain injury, CVA, stroke, meningitis).
- Decreased cognitive functioning during inclusion, as defined by a Telephone Interview for Cognitive Status (TICS) score less than 27. The Telephone Interview for Cognitive Status (TICS) will be used directly after signing informed consent and is a brief, standardized test for cognitive functioning that was developed for use in situations where in-person cognitive screening is impractical of inefficient (25, 26).
- Active delirium during inclusion
- Lack of formal home address
- Moribund patients at the ICU or hospital ward with a life expectancy <48 hours of receiving palliative care

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the difference in the severity of PTSD-related symptoms six months after ICU discharge between patients in the control group and 1) patients in the early ICU-VR group, and 2) patients in the late ICU-VR group.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are:<br>1) The difference in the severity of PTSD-, anxiety- and depression-related symptoms and the prevalence of probable PTSD throughout follow-up at each follow-up time-point and throughout follow-up.<br>2) The difference in Health-Related Quality of Life at each follow-up time-point and throughout follow-up.<br>3) Patients’ satisfaction with ICU aftercare