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 syndroom (angst/post-traumatische stress/depressie); anxiety; depression; post-traumatic stress disoder; 10002861

• Registration Number: NL-OMON54059
• Lead Sponsor: Franciscus Gasthuis & Vlietland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 270

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.
• 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
<p>The primary endpoint is the difference in the severity of PTSD-related symptoms<br /><br>six months after ICU discharge between patients in the control group, patients<br /><br>in the early ICU-VR group, and patients in the late ICU-VR group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondart study endpoints are the severity of PTSD-, anxiety, and<br /><br>depression-related symptoms and the prevlaence of probable PTSD, anxiety and<br /><br>depression up to 12 months after hospital discharge and the overall, mental,<br /><br>and physical health-related quality of life up to 12 months after hospital<br /><br>discharge.</p><br>