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

NCT07456384 | Not Yet Recruiting

• 1 other identifier: PL26023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress Disorder; Post-traumatic

Keywords

craniocerebral trauma; stress disorders; post-traumatic; anxiety; critical care; sensory stimulation; caregivers

Outcome Measures

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.

  Day 90 after critical care discharge or patient's death

Secondary Outcomes (2)

• Anxiety and/or depressive symptoms in relatives at Day 90

  Day 90 after critical care discharge or patient's death

• Level of consciousness of the patient at discharge from critical care

  At discharge from critical care, up to 1 year

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Participants receive standard critical care. Patient stimulation is performed according to usual practice by the healthcare team (e.g., during routine morning nursing care). Relatives are welcomed according to standard visiting policies; no structured family-delivered neurosensory stimulation protocol is implemented.

Behavioral: Standardized family-delivered neurosensory stimulation protocol

Family-delivered neurosensory stimulation

EXPERIMENTAL

Relatives deliver a standardized neurosensory (multisensory) stimulation protocol to the brain-injured patient during the early awakening phase after sedation cessation, under supervision of the healthcare team. The intervention includes an interview to identify reference relative(s) and patient habits, structured training on stimulation of the five senses, and traceability of stimulation activities performed at each visit.

Behavioral: Standardized family-delivered neurosensory stimulation protocol

Interventions

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.

Family-delivered neurosensory stimulation; Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Marie MULLER

Reims, France

Location

MeSH Terms

Conditions

Stress Disorders, Traumatic; Craniocerebral Trauma; Anxiety Disorders

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Central Study Contacts

Sylvain BRICHET

CONTACT

03 10 73 69 97; sbrichet@chu-reims.fr

Emmanuelle RACLOT

CONTACT

03 26 78 90 59; eraclot@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants are assigned to one of two or more groups in parallel for the duration of the study

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: March 6, 2026

Record last verified: 2026-02

Locations

FR (1)