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

March 4, 2026 updated by: CHU de Reims

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-traumatic stress symptoms in relatives at Day 90
Time Frame: 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.
Day 90 after critical care discharge or patient's death

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxiety and/or depressive symptoms in relatives at Day 90
Time Frame: Day 90 after critical care discharge or patient's death
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
Time Frame: At discharge from critical care, up to 1 year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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