Sensory Stimulation Program Delivered by Family Members of Brain-injured Patients in Critical Care: Effect on Relatives' Post-traumatic Stress
Condition(s) studied
Investigational drug(s) / intervention(s)
Standardized family-delivered neurosensory stimulation protocol: A 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.
Study summary
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
Primary outcome measure(s)
- Post-traumatic stress symptoms in relatives at Day 90 — Day 90 after critical care discharge or patient's death
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Marie MULLER | Reims | France |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07456384 on ClinicalTrials.gov ↗ ← All trials in France