NCT07525284 Reported Experience Measurement on Reducing Patient Discomfort in Intensive Care
| NCT ID | NCT07525284 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Almaviva Sante |
| Condition | PTSD - Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,242 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,242 participants in total. It began in 2025-12-19 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07525284 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PTSD - Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07525284 currently recruiting?
Yes, NCT07525284 is actively recruiting participants. Contact the research team at pierrekalfon@sfr.fr for enrollment information.
Where is the NCT07525284 trial being conducted?
This trial is being conducted at Aubagne, France.
Who is sponsoring the NCT07525284 clinical trial?
NCT07525284 is sponsored by Almaviva Sante. The trial plans to enroll 1,242 participants.
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