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Starting soon Not applicable

Sensory Stimulation Program Delivered by Family Members of Brain-injured Patients in Critical Care: Effect on Relatives' Post-traumatic Stress

NCT07456384 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-05
Last updated
2026-03-06

Condition(s) studied

Stress DisorderPost-traumatic

Investigational drug(s) / intervention(s)

Standardized family-delivered neurosensory stimulation protocol

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
inclusion criteria : * 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. * French-speaking (sufficient proficiency to understand study information and complete questionnaires). exclusion criteria : * 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.

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)

FacilityCityRegionStatus
Marie MULLER Reims France
Official registry record

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