PTSD - Post Traumatic Stress DisorderPREMREANCT07525284
Reported Experience Measurement on Reducing Patient Discomfort in Intensive Care
A study testing PREMREA program in people with PTSD - Post Traumatic Stress Disorder, run by Almaviva Sante at 1 site in France.
Trial summary
Hospitalisation in intensive care is always traumatic and can lead to a long rehabilitation process, slowed down by symptoms of anxiety and/or depression, and/or post-traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- PREMREA program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,242 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2025to 31 Dec 2027
- 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
- Patient, male or female, aged ≥ 18 years
- Patient discharged alive from intensive care
- Patient hospitalised in intensive care for at least three calendar days
- Patient affiliated with or beneficiary of a social security scheme
- Patient who speaks French and has signed an informed consent form
Who cannot join
- Patients whose situation is incompatible with completing the IPREA questionnaire
- Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision
- Patients hospitalised without consent
- Pregnant and/or breastfeeding women
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, 1 recruiting
- Recruiting
Hôpital Privé La Casamance
Aubagne, France, 13400
Pierre KALFON, MD, + 33 6 38 39 24 18, pierrekalfon@sfr.fr
About this study
Hospitalisation in intensive care is always traumatic and can lead to a long rehabilitation process, slowed down by symptoms of anxiety and/or depression, and/or post-traumatic stress disorder (PTSD). These psychiatric disorders, or post-intensive care syndrome (PICS), can persist for several years after hospitalisation in intensive care and cause functional disability. They are associated with the use of psychotropic drugs and mental health services, and impair health-related quality of life.
This research is based on the hypothesis that the traumatic nature of intensive care hospitalisation can be reduced by implementing programmes to improve intensive care hospitalisation conditions, promoting changes in the practices of all healthcare professionals involved in intensive care.
Read more
IPREA3 study (Kalfon et al, 2017) demonstrated that implementation of a tailor-made, multi-component programme, led by a doctor/non-medical caregiver significantly reduced the overall discomfort score (derived from the IPREA questionnaire) perceived by patients hospitalised in an intensive care unit with sufficient experience in applying this programme, having used it for at least 5 months (Kalfon et al, 2017) .
The originality and interest of this research, in comparison with the IPREA3 study, lie in the following aspects:
- the use of the most recent version of the IPREA questionnaire,
- the questionnaire was completed by the patient themselves without the intervention of a caregiver (self-administration)
- the fact that new care practices, aimed at humanising a stay in intensive care and making the experience of a stay in intensive care less traumatic, were described after the publication of the IPREA3 study a
- a longer programme learning period of 9 months (compared to 5 months during the IPREA3 study)
- the launch of the PREMREA programme with a conference led by a patient expert
Read the detailed description
Hospitalisation in intensive care is always traumatic and can lead to a long rehabilitation process, slowed down by symptoms of anxiety and/or depression, and/or post-traumatic stress disorder (PTSD). These psychiatric disorders, or post-intensive care syndrome (PICS), can persist for several years after hospitalisation in intensive care and cause functional disability. They are associated with the use of psychotropic drugs and mental health services, and impair health-related quality of life.
This research is based on the hypothesis that the traumatic nature of intensive care hospitalisation can be reduced by implementing programmes to improve intensive care hospitalisation conditions, promoting changes in the practices of all healthcare professionals involved in intensive care.
IPREA3 study (Kalfon et al, 2017) demonstrated that implementation of a tailor-made, multi-component programme, led by a doctor/non-medical caregiver duo and based on:
- a systematic assessment by the caregiver in charge of the patient on the day of discharge from intensive care of any discomfort experienced during the entire stay, based on a specific questionnaire (Inconforts des Patients de REAnimation - IPREA - comprising 16 items of discomfort (Kalfon et al, 2010),
- immediate feedback to caregivers with reminders of simple predetermined measures,
- monthly comparative feedback to promote a positive spirit of emulation among participating intensive care units, significantly reduced the overall discomfort score (derived from the IPREA questionnaire) perceived by patients hospitalised in an intensive care unit with sufficient experience in applying this programme, having used it for at least 5 months (Kalfon et al, 2017) .
The originality and interest of this research, in comparison with the IPREA3 study, lie in the following aspects:
- the use of the most recent version of the IPREA questionnaire, which includes 18 discomfort items
- the questionnaire was completed by the patient themselves without the intervention of a caregiver (self-administration) to avoid potential bias associated with the administration of the questionnaire by a caregiver from the unit in which the patient was hospitalised
- the fact that new care practices, aimed at humanising a stay in intensive care and making the experience of a stay in intensive care less traumatic, were described after the publication of the IPREA3 study and then applied without assessing the impact on patient perception as measured using the IPREA questionnaire
- a longer programme learning period of 9 months (compared to 5 months during the IPREA3 study) to allow healthcare teams to better assimilate the changes to care practices decided upon during monthly feedback sessions
- the launch of the PREMREA programme with a conference led by a patient expert to raise awareness among intensive care teams
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- PREMREA program
- Keywords
- PTSD, IPREA questionnaire
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREMREA programOther
PREMREA is a tailor-made, multi-component program led by a doctor/non-medical caregiver duo, consisting of the following elements:
- Systematic completion of the 18-item IPREA questionnaire by the patient on the day of discharge.
- Monthly feedback to all intensive care staff presenting the monthly results of the department and other participating departments, led by the doctor/non-medical caregiver duo.
- Implementation of specific measures in the department, decided collectively and coordinated by the doctor/non-medical caregiver duo, and monitoring of these measures.
| Study group | Role | What they receive |
|---|---|---|
| Arm PREMREA + | Experimental | Patients in this arm will benefit from measures taken from PREMREA program Receives: Other: PREMREA program |
| Arm PREMREA - | No intervention | Patients in this arm do not benefit from measures taken from PREMREA program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall discomfort score
Overall discomfort score is obtained from the 18-item IPREA questionnaire. It consists of 18 pre-established items describing the most common sources of discomfort in intensive care : noise, excessive light, discomfort related to unfamiliar bedding, lack of sleep, thirst, hunger, cold, heat, pain, restriction of autonomy due to cables and infusion lines, lack of privacy, anxiety, isolation, limited visits from loved ones, lack of a telephone, insufficient information about current health status, difficulty breathing, depression (Baumstarck et al, 2019). For each of the 18 discomfort items, the patient gives a score between 0 (no discomfort at all) and 10 (maximum discomfort imaginable). The overall discomfort score is calculated as the average of the 18 discomfort scores multiplied by 10, resulting in a score between 0 and 100
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start19 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almaviva Sante
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525284
- Sponsor's protocol ID
- 2025-A01796-43
- Acronym
- PREMREA
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reported Experience Measurement on Reducing Patient Discomfort in Intensive Care
- ClinicalTrials.gov ID
- NCT07525284
- Acronym / sponsor ID
- PREMREA / 2025-A01796-43
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- PTSD, IPREA questionnaire
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,242 participants (estimated)
- Lead sponsor
- Almaviva SanteUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Apr 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.
Hospitalisation in intensive care is always traumatic and can lead to a long rehabilitation process, slowed down by symptoms of anxiety and/or depression, and/or post-traumatic stress disorder (PTSD). These psychiatric disorders, or post-intensive care syndrome (PICS), can persist for several years after hospitalisation in intensive care and cause functional disability. They are associated with the use of psychotropic drugs and mental health services, and impair health-related quality of life.
This research is based on the hypothesis that the traumatic nature of intensive care hospitalisation can be reduced by implementing programmes to improve intensive care hospitalisation conditions, promoting changes in the practices of all healthcare professionals involved in intensive care.
IPREA3 study (Kalfon et al, 2017) demonstrated that implementation of a tailor-made, multi-component programme, led by a doctor/non-medical caregiver significantly reduced the overall discomfort score (derived from the IPREA questionnaire) perceived by patients hospitalised in an intensive care unit with sufficient experience in applying this programme, having used it for at least 5 months (Kalfon et al, 2017) .
The originality and interest of this research, in comparison with the IPREA3 study, lie in the following aspects:
- the use of the most recent version of the IPREA questionnaire,
- the questionnaire was completed by the patient themselves without the intervention of a caregiver (self-administration)
- the fact that new care practices, aimed at humanising a stay in intensive care and making the experience of a stay in intensive care less traumatic, were described after the publication of the IPREA3 study a
- a longer programme learning period of 9 months (compared to 5 months during the IPREA3 study)
- the launch of the PREMREA programme with a conference led by a patient expert
Detailed description
Hospitalisation in intensive care is always traumatic and can lead to a long rehabilitation process, slowed down by symptoms of anxiety and/or depression, and/or post-traumatic stress disorder (PTSD). These psychiatric disorders, or post-intensive care syndrome (PICS), can persist for several years after hospitalisation in intensive care and cause functional disability. They are associated with the use of psychotropic drugs and mental health services, and impair health-related quality of life.
This research is based on the hypothesis that the traumatic nature of intensive care hospitalisation can be reduced by implementing programmes to improve intensive care hospitalisation conditions, promoting changes in the practices of all healthcare professionals involved in intensive care.
IPREA3 study (Kalfon et al, 2017) demonstrated that implementation of a tailor-made, multi-component programme, led by a doctor/non-medical caregiver duo and based on:
- a systematic assessment by the caregiver in charge of the patient on the day of discharge from intensive care of any discomfort experienced during the entire stay, based on a specific questionnaire (Inconforts des Patients de REAnimation - IPREA - comprising 16 items of discomfort (Kalfon et al, 2010),
- immediate feedback to caregivers with reminders of simple predetermined measures,
- monthly comparative feedback to promote a positive spirit of emulation among participating intensive care units, significantly reduced the overall discomfort score (derived from the IPREA questionnaire) perceived by patients hospitalised in an intensive care unit with sufficient experience in applying this programme, having used it for at least 5 months (Kalfon et al, 2017) .
The originality and interest of this research, in comparison with the IPREA3 study, lie in the following aspects:
- the use of the most recent version of the IPREA questionnaire, which includes 18 discomfort items
- the questionnaire was completed by the patient themselves without the intervention of a caregiver (self-administration) to avoid potential bias associated with the administration of the questionnaire by a caregiver from the unit in which the patient was hospitalised
- the fact that new care practices, aimed at humanising a stay in intensive care and making the experience of a stay in intensive care less traumatic, were described after the publication of the IPREA3 study and then applied without assessing the impact on patient perception as measured using the IPREA questionnaire
- a longer programme learning period of 9 months (compared to 5 months during the IPREA3 study) to allow healthcare teams to better assimilate the changes to care practices decided upon during monthly feedback sessions
- the launch of the PREMREA programme with a conference led by a patient expert to raise awareness among intensive care teams
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm PREMREA + | Experimental | Other: PREMREA programPatients in this arm will benefit from measures taken from PREMREA program |
| Arm PREMREA - | No intervention | –Patients in this arm do not benefit from measures taken from PREMREA program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient, male or female, aged ≥ 18 years
- Patient discharged alive from intensive care
- Patient hospitalised in intensive care for at least three calendar days
- Patient affiliated with or beneficiary of a social security scheme
- Patient who speaks French and has signed an informed consent form
Key exclusion criteria (4 listed)
- Patients whose situation is incompatible with completing the IPREA questionnaire
- Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision
- Patients hospitalised without consent
- Pregnant and/or breastfeeding women
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 |
|---|---|---|
| PREMREA programPREMREA is a tailor-made, multi-component program led by a doctor/non-medical caregiver duo, consisting of the following elements: * Systematic completion of the 18-item IPREA questionnaire by the patient on the day of discharge. * Monthly feedback to all intensive care staff presenting the monthly results of the department and other participating departments, led by the doctor/non-medical caregiver duo. * Implementation of specific measures in the department, decided collectively and coordinated by the doctor/non-medical caregiver duo, and monitoring of these measures. | Other | Arm PREMREA + |
Primary outcome
Overall discomfort score
Time frame: 3 months
Overall discomfort score is obtained from the 18-item IPREA questionnaire. It consists of 18 pre-established items describing the most common sources of discomfort in intensive care : noise, excessive light, discomfort related to unfamiliar bedding, lack of sleep, thirst, hunger, cold, heat, pain, restriction of autonomy due to cables and infusion lines, lack of privacy, anxiety, isolation, limited visits from loved ones, lack of a telephone, insufficient information about current health status, difficulty breathing, depression (Baumstarck et al, 2019). For each of the 18 discomfort items, the patient gives a score between 0 (no discomfort at all) and 10 (maximum discomfort imaginable). The overall discomfort score is calculated as the average of the 18 discomfort scores multiplied by 10, resulting in a score between 0 and 100
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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 PREMREA program in people with PTSD - Post Traumatic Stress Disorder, run by Almaviva Sante 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 4 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: looking for participants now, as of the sponsor's last update on 13 Apr 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 Pierre KALFON, MD (+ 33 6 38 39 24 18, pierrekalfon@sfr.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall discomfort score (time frame: 3 months). 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 13 Apr 2026.