Post-traumatic Stress DisorderExpe-ReaNCT07339891
Experience of Staying in Intensive Care and Impact on Quality of Life
An observational study of Post-traumatic Stress Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
It now seems well established that post-traumatic stress disorder following a stay in intensive care is one of the factors that affects patients' quality of life after they leave hospital. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2025to 23 Jun 2026
- Phase
- Observational
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patient (≥ 18 years) having a stay in intensive care > 48 hours
Who may be able to join
- Adult patient (≥ 18 years)
- Stay in intensive care > 48 hours
Who cannot join
- Admission to intensive care following scheduled surgery.
- Readmission to intensive care (previous admission within the 30 days prior).
- Patient under legal guardianship
- Inability to complete a questionnaire
- Poor reading and/or speaking comprehension of French
- Patient under guardianship or conservatorship.
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
Service de Réanimation Chirurgicale - CHU de Strasbourg - France
Strasbourg, 67091
Coralie PAUZET, MD, 33 3 69 55 05 57, coralie.pauzet@chru-strasbourg.fr
Coralie Pauzet, MD
About this study
It now seems well established that post-traumatic stress disorder following a stay in intensive care is one of the factors that affects patients' quality of life after they leave hospital.
Several qualitative and quantitative studies suggest that there are several factors associated with the onset of this post-traumatic stress disorder, including the absence of memory of the stay in intensive care. With this in mind, some intensive care units (in France and abroad) are implementing measures to improve the patient experience during their stay, particularly to compensate for this lack of memory: several studies show a link between the introduction of intensive care unit logbooks and a decrease in the incidence of post-traumatic stress disorder after returning home.
The aim of this research project is to measure the experience of the stay in intensive care and its possible impact on quality of life. It is therefore part of a process of implementing measures within general and cardiovascular surgical intensive care units, aimed at better assessing and improving the quality of life of patients after a stay in intensive care.
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Post-traumatic stress disorder, Stay in intensive care
- Medical subject headings
- Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
ICE questionnaire score
ICE (Impact Confidence Experience) questionnaire score:
The scores for each letter (I, C, E) are added together or averaged.
The higher the score, the better. This indicates a positive experience, trust, and a significant impact.
Simple example:
- Impact = 8/10 → The service was very helpful.
- Trust = 9/10 → I trust this team.
- Experience = 7/10 → My experience was quite good.
Average ICE score = (8 + 9 + 7) ÷ 3 = 8/10
Measured: Between 1 and 3 days after discharge from the intensive care unit.
Quality of life questionnaire score (SF36)
The SF-36 is a health questionnaire consisting of 36 questions.
Each dimension receives a score from 0 to 100:
- 100 = very good quality of life
- 0 = very poor quality of life
Measured: Day 30 after discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start23 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completion23 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339891
- Sponsor's protocol ID
- 9771
- Acronym
- Expe-Rea
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of Staying in Intensive Care and Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT07339891
- Acronym / sponsor ID
- Expe-Rea / 9771
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Post-traumatic stress disorder, Stay in intensive care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 23 Jun 2026 (estimated)
- First posted
- 14 Jan 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.
It now seems well established that post-traumatic stress disorder following a stay in intensive care is one of the factors that affects patients' quality of life after they leave hospital.
Several qualitative and quantitative studies suggest that there are several factors associated with the onset of this post-traumatic stress disorder, including the absence of memory of the stay in intensive care. With this in mind, some intensive care units (in France and abroad) are implementing measures to improve the patient experience during their stay, particularly to compensate for this lack of memory: several studies show a link between the introduction of intensive care unit logbooks and a decrease in the incidence of post-traumatic stress disorder after returning home.
The aim of this research project is to measure the experience of the stay in intensive care and its possible impact on quality of life. It is therefore part of a process of implementing measures within general and cardiovascular surgical intensive care units, aimed at better assessing and improving the quality of life of patients after a stay in intensive care.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patient (≥ 18 years) having a stay in intensive care > 48 hours
Key inclusion criteria (2 listed)
- Adult patient (≥ 18 years)
- Stay in intensive care > 48 hours
Key exclusion criteria (6 listed)
- Admission to intensive care following scheduled surgery.
- Readmission to intensive care (previous admission within the 30 days prior).
- Patient under legal guardianship
- Inability to complete a questionnaire
- Poor reading and/or speaking comprehension of French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICE questionnaire score
Time frame: Between 1 and 3 days after discharge from the intensive care unit.
ICE (Impact Confidence Experience) questionnaire score: The scores for each letter (I, C, E) are added together or averaged. The higher the score, the better. This indicates a positive experience, trust, and a significant impact. Simple example: * Impact = 8/10 → The service was very helpful. * Trust = 9/10 → I trust this team. * Experience = 7/10 → My experience was quite good. Average ICE score = (8 + 9 + 7) ÷ 3 = 8/10
Quality of life questionnaire score (SF36)
Time frame: Day 30 after discharge from hospital
The SF-36 is a health questionnaire consisting of 36 questions. Each dimension receives a score from 0 to 100: * 100 = very good quality of life * 0 = very poor quality of life
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 14 Jan 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?
An observational study of Post-traumatic Stress Disorder, run by University Hospital, Strasbourg, France 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 2 inclusion and 6 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 14 Jan 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 Coralie PAUZET, MD (33 3 69 55 05 57, coralie.pauzet@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICE questionnaire score (time frame: Between 1 and 3 days after discharge from the intensive care unit.). The study lists 2 primary outcomes in all. 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 14 Jan 2026.