Stress DisorderStimulSensReaNCT07456384
Sensory Stimulation Program Delivered by Family Members of Brain-injured Patients in Critical Care: Effect on Relatives' Post-traumatic Stress
A study testing Standardized family-delivered neurosensory stimulation protocol in people with Stress Disorder and Post-traumatic, run by CHU de Reims at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorder, Post-traumatic
- What is being tested?
- Standardized family-delivered neurosensory stimulation protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- May 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Marie MULLER
Reims
Sylvain BRICHET, 03 10 73 69 97 ext. 0033, sbrichet@chu-reims.fr
Emmanuelle RACLOT, 03 26 78 90 59 ext. 0033, eraclot@chu-reims.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Disorder, Post-traumatic
- Being tested
- Standardized family-delivered neurosensory stimulation protocol
- Keywords
- craniocerebral trauma, stress disorders, post-traumatic, anxiety, critical care, sensory stimulation, caregivers
- Medical subject headings
- Stress Disorders, Traumatic, Craniocerebral Trauma, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized family-delivered neurosensory stimulation protocolBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standardized family-delivered neurosensory stimulation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 90 after critical care discharge or patient's death
Secondary outcomes (2)
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.
Measured: 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
Measured: At discharge from critical care, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress DisorderStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456384
- Sponsor's protocol ID
- PL26023
- Acronym
- StimulSensRea
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07456384
- Acronym / sponsor ID
- StimulSensRea / PL26023
- Conditions
- Stress Disorder, Post-traumatic
- Keywords
- craniocerebral trauma, stress disorders, post-traumatic, anxiety, critical care, sensory stimulation, caregivers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Behavioral: Standardized family-delivered neurosensory stimulation protocolParticipants 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. |
| Family-delivered neurosensory stimulation | Experimental | Behavioral: Standardized family-delivered neurosensory stimulation protocolRelatives 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized family-delivered neurosensory stimulation protocolA 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. | Behavioural | Family-delivered neurosensory stimulation, Standard care |
Primary outcome
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.
2 secondary outcomes
Anxiety and/or depressive symptoms in relatives at Day 90
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized family-delivered neurosensory stimulation protocol in people with Stress Disorder and Post-traumatic, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvain BRICHET (03 10 73 69 97 ext. 0033, sbrichet@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic stress symptoms in relatives at Day 90 (time frame: Day 90 after critical care discharge or patient's death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.