The primary objective is to assess the effect of ICU-VR, offered early (within two weeks after ICU discharge) or late (three months after ICU discharge during an ICU follow-up clinic), on the severity of PTSD-related symptoms six months after ICU…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
post-intensive care syndroom (angst/post-traumatische stress/depressie)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the difference in the severity of PTSD-related symptoms
six months after ICU discharge between patients in the control group, patients
in the early ICU-VR group, and patients in the late ICU-VR group.
Secondary outcome
The secondart study endpoints are the severity of PTSD-, anxiety, and
depression-related symptoms and the prevlaence of probable PTSD, anxiety and
depression up to 12 months after hospital discharge and the overall, mental,
and physical health-related quality of life up to 12 months after hospital
discharge.
Background summary
Due to advances in critical care medicine, more patients survive their critical
illness. Up to 60% of these Intensive Care Unit (ICU) survivors experience
long-term physical, cognitive and psychological impairments, collectively
referred to as the Post-Intensive Care Syndrome (PICS), adversely impacting the
health-related quality of life (HRQoL). The psychological component of PICS
comprises anxiety-, depression- and posttraumatic stress disorder- (PTSD-)
related complaints and is known to be an important determinant for a decreased
HRQoL. An effective preventive or therapeutic strategy to improve these
impairments is still lacking. We recently demonstrated that an ICU-specific
Virtual Reality (ICU-VR) intervention is safe, feasible, and immersive. Also,
ICU-VR appears to improve psychological recovery, mental HRQoL, and
satisfaction with ICU aftercare in a two-center pilot study.
Study objective
The primary objective is to assess the effect of ICU-VR, offered early (within
two weeks after ICU discharge) or late (three months after ICU discharge during
an ICU follow-up clinic), on the severity of PTSD-related symptoms six months
after ICU discharge. Secondary objectives are to assess the effect of ICU-VR,
offered early of late, on the prevalence of severity of psychological distress
at each follow-up time-point and during follow-up, to determine whether ICU-VR
is most effective when offered early of later after ICU discharge, and to asses
patients* satisfaction with ICU aftercare and patients* perspectives on the
ICU-VR intervention.
Study design
A multicenter, three-armed randomized controlled trial.
Intervention
An Intensive Care Unit-specific Virtual Reality (ICU-VR) intervention, designed
by an interdisciplinary team of intensivists, ICU nurses, a psychiatrist, a
psychologist, and a former ICU patient, to expose patients to the ICU
environment while offering treatment- and department-related information and
reframing delusional memories. During the 12-minute lasting intervention,
patients re-experience different facets of ICU treatment and receive
information on the ICU environment, treatment and workflow.
Study burden and risks
No additional burden is expected. ICU-VR is proven safe and feasible. No safety
issues or adverse events have been reported using ICU-VR nor in other studies
using VR. VR is a non*invasive technique and participants do not have to
undergo extra procedures. In addition, the questionnaire that is being used is
validated and used in multiple clinical studies.
Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL78555.100.21 |
| Other | NL9812 |
| OMON | NL-OMON28097 |