About this trial
Severe traumatic brain injuries are common and can lead to major long-term disability. Patients with severe brain injury often require admission to critical care. For relatives, this period is highly distressing: during and after an ICU stay, family members frequently experience anxiety, depression, and post-traumatic stress symptoms.
In recent years, family involvement in critical care has been associated with better communication with the healthcare team and fewer psychological difficulties among relatives. In parallel, findings from neuroscience suggest that early multisensory stimulation (engaging the five senses) may help support brain recovery by promoting neuronal connections during the awakening phase.
This study evaluates whether a standardized neurosensory stimulation program, delivered by trained relatives of brain-injured patients hospitalized in critical care, can reduce post-traumatic stress symptoms in those relatives. We hypothesize that involving relatives in a structured, supervised multisensory stimulation protocol during the patient's awakening phase (before transfer to rehabilitation) will decrease relatives' post-traumatic stress symptoms at 3 months after critical care discharge (or after the patient's death). We also expect potential secondary benefits on patients' awakening and recovery trajectory.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Relative (family member or close person) of an eligible brain-injured patient hospitalized in critical care
Able and willing to provide informed consent to participate.
Available to attend at least three visits during the patient's critical care hospitalization.
Disqualifiers
Non-French-speaking or insufficient French proficiency to complete study procedures/questionnaires.
Insufficient understanding/comprehension of the study procedures, as assessed during the initial interview after explanations by the study nurse.
Trial design
Parallel
Treatments tested in this trial
Standardized family-delivered neurosensory stimulation protocol
BehavioralA structured multisensory stimulation program delivered by trained relatives (reference family member\[s\]) during visits, targeting sight, hearing, touch, smell and (when appropriate) taste. Components: (1) baseline interview to tailor stimulation to patient preferences/habits; (2) training in standardized techniques and safety guidance; (3) supervised implementation with staff support; (4) documentation/traceability of each session.
Treatment groups
Trial outcomes
Primary outcomes
Post-traumatic stress symptoms in relatives at Day 90
Proportion of participating relatives with an Impact of Event Scale-Revised (IES-R) total score ≥30, assessed by telephone, at Day 90 after critical care discharge or patient death.
Secondary outcomes
Anxiety and/or depressive symptoms in relatives at Day 90
Proportion of participating relatives with Hospital Anxiety and Depression Scale (HADS) Anxiety and/or Depression subscale score \> 8 at Day 90 after critical care discharge or patient death, assessed by telephone.
Level of consciousness of the patient at discharge from critical care
Coma Recovery Scale-Revised (CRS-R) total score assessed at discharge from critical care
Sponsors and contacts
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