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

Evaluation of the Impact of a Standardized Neurosensory Stimulation Protocol Delivered by Relatives of Brain-injured Patients Hospitalized in Critical Care on Post-traumatic Stress in Those Relatives

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Disorder; Post-traumatic
• Intervention / Treatment: Behavioral: Standardized family-delivered neurosensory stimulation protocol

Detailed Description

Traumatic brain injury is a major public health issue, with a substantial number of severe cases requiring critical care management. Beyond the patient's neurological prognosis, critical care admission for brain injury exposes relatives to intense stressors and is associated with anxiety, depressive symptoms, and post-traumatic stress symptoms. Published studies have reported wide but consistently high rates of post-traumatic stress symptoms among relatives of ICU patients.

Family-centered approaches in intensive care have been increasingly promoted. Prior research has suggested that involving family members in care processes can improve communication with the clinical team and may reduce psychological distress among relatives. Building on this rationale, the present study aims to integrate relatives of brain-injured patients into an early, structured care activity: standardized neurosensory stimulation.

The intervention is grounded in neuroscientific principles supporting early stimulation during the awakening phase, with the intent to provide repeated sensory inputs that may help maintain and strengthen neuronal networks. To translate these principles into critical care practice, a standardized protocol of multisensory stimulation by relatives of brain-injured patients has been developed.

The study is conducted in a surgical and trauma ICU setting, with patient trajectories potentially including step-down surgical high-dependency care. Participants (i.e. patients and their relatives willing to participate) are enrolled shortly after cessation of sedation, during the early awakening period. Participants are randomized to one of two parallel groups: (1) usual care, where stimulation occurs according to standard clinical practice led by the care team and relatives follow standard visiting procedures; or (2) a standardized family-delivered neurosensory stimulation program. In the intervention group, the program includes several key components: an interview with relatives to identify the reference family member(s) and to collect relevant information on the patient's habits and preferences; presentation of the standardized stimulation protocol and training of the relative(s) in practical methods to stimulate the five senses, with an emphasis on adapting stimulation to the patient's condition; structured traceability of stimulation activities performed during visits.

Relatives are followed up after the critical care period to assess psychological outcomes, and patients' level of awakening is monitored during critical care stay and discharge. Overall, the study evaluates whether a standardized, supervised, family-delivered neurosensory stimulation approach can reduce relatives' post-traumatic stress symptoms and potentially support patient recovery during the transition from awakening in critical care to rehabilitation.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvain BRICHET; Phone Number: 0033 03 10 73 69 97; Email: sbrichet@chu-reims.fr
• Study Contact Backup: Name: Emmanuelle RACLOT; Phone Number: 0033 03 26 78 90 59; Email: eraclot@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Marie Muller
    • Contact: Sylvain BRICHET; Phone Number: 0033 03 10 73 69 97; Email: sbrichet@chu-reims.fr
    • Contact: Emmanuelle RACLOT; Phone Number: 0033 03 26 78 90 59; Email: eraclot@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care; 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; 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.
Experimental: Family-delivered neurosensory stimulation; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 90 after critical care discharge or patient's death
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	At discharge from critical care, up to 1 year

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: critical care; anxiety; caregivers; craniocerebral trauma; stress disorders; post-traumatic; sensory stimulation
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Trauma, Nervous System; Anxiety Disorders; Stress Disorders, Traumatic; Craniocerebral Trauma
• Other Study ID Numbers: PL26023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No