Measuring and reducing patient discomfort during intensive care
Official title: Reported Experience Measurement on Reducing Patient Discomfort in Intensive Care
Run by Almaviva Sante · NCT07525284 · Data updated 2026-11-12
This program tests whether a tailored, multi-component feedback program using the IPREA questionnaire can reduce traumatic experiences and later PTSD symptoms for adults discharged after at least three days in intensive care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1242 (estimated) |
| Sponsor | Almaviva Sante Academic / other |
| Locations | 1 site (Aubagne, France) |
| Status | Recruiting |
| Started | December 19, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07525284 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who were hospitalized in intensive care for at least three calendar days, discharged alive, speak French, can complete the IPREA questionnaire, and are covered by a social security scheme are ideal candidates.
✕Probably not a fit
Patients who cannot complete the IPREA questionnaire, those under legal protection or detained by judicial/administrative order, individuals hospitalized without consent, and pregnant or breastfeeding women are excluded and unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The program implements the IPREA 16-item discomfort questionnaire at ICU discharge and provides immediate, simple feedback to caregivers plus monthly comparative unit-level reports to drive practice change. A doctor/non-medical caregiver team leads the intervention and promotes specific reminders and adjustments in routine care based on reported patient discomforts. The approach builds on the IPREA3 model of systematic measurement and feedback to reduce overall discomfort scores during ICU stays. The current implementation seeks to broaden that model and examine downstream effects on anxiety, depression, and post-intensive care syndrome symptoms.
Why it matters
Potential benefit: If successful, the program could reduce traumatic ICU experiences, lower subsequent PTSD/anxiety/depression rates, and improve recovery and quality of life after intensive care.
How similar studies have gone: A prior IPREA3 study (Kalfon et al., 2017) showed that a similar tailor-made, multi-component program significantly reduced overall ICU discomfort scores, though long-term effects on PTSD/PICS remain less well established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hôpital Privé La Casamance
Aubagne, France, France Recruiting
Study contacts
- Study coordinator: Pierre KALFON, MD
- Email: pierrekalfon@sfr.fr
- Phone: + 33 6 38 39 24 18
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.