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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCHU de Reims

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Standardized family-delivered neurosensory stimulation protocol

    Behavioral

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Standard careActive comparator 1 intervention
Group B: Family-delivered neurosensory stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 90 after critical care discharge or patient's death

Secondary outcomes

1

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.

Time frame
Day 90 after critical care discharge or patient's death
2

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

Time frame
At discharge from critical care, up to 1 year

Other outcomes

Sponsors and contacts

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