Status:
RECRUITING
Immersive Sensory Projections for Hospitalized Patients
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborating Sponsors:
Euraxi Pharma
Conditions:
Hospitalism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the impact of adding three sensory elements (visual, auditory, olfactory) on reducing discomfort in patients hospitalized in the intensive care unit/continuing c...
Detailed Description
The IHP trial is multicenter, interventional, prospective, randomized, controlled, open-label study. The study population consists of adult patients hospitalized in an intensive care or continuing ca...
Eligibility Criteria
Inclusion
- Age ≥ 18 years ;
- Patient hospitalized in intensive care or continuing care unit for an estimated minimum of 48 hours;
- Patient hospitalized for a medical indication (including in the pre-surgical phase) or in the post-surgical phase;
- Patient or support person who speaks and understands French, has understood the research procedures and is able to complete the questionnaires;
- For women of childbearing age (non-menopausal), even for those on contraception: negative pregnancy test (urinary); If positive: completed by a biological test;
- Patient or trusted support person having been informed and having signed an informed consent form to participate in the study.
Exclusion
- Deaf or blind patient;
- Asthmatic patient with background treatment;
- Epileptic patient or known history of convulsion;
- Known allergy or intolerance to essential oils or to a component of essential oils;
- Patient transferred from another intensive care unit;
- Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- Breast-feeding or pregnant women;
- Patient or support person unable to understand information relating to the study (linguistic, psychological, cognitive, etc.);
- Unconscious patient with no relative or support person present;
- Homeless patient;
- Patient with known severe psychiatric illness such as chronic hallucinatory psychosis or paranoid syndrome;
- Patient participating in or being excluded from another clinical trial;
- Patient not covered by a social security scheme.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT06577870
Start Date
May 20 2025
End Date
June 1 2026
Last Update
May 29 2025
Active Locations (1)
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1
Hôpital Privé Jacques Cartier
Massy, France, 91300