Hospitalism
Conditions
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 care unit.
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 care unit for medical or surgical reasons, conscious or unconscious under mechanical ventilation. All patients participating in the study will be managed according to usual practices in intensive care and continuing care units. All patients and their relatives will be monitored and supported by the medical team as in normal practice. The study will be offered to the patient or a close relative/trusted person on admission to hospital.
Interventions
PROCEDUREHospitalization in intensive care or continuing care unit
Hospitalization in intensive care or continuing care unit for medical reasons or surgery, conscious or unconscious under mechanical ventilation. Resuscitation patients are then cared for in a continuing care unit.
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Euraxi Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Open-label study
Intervention model description
Multicenter, interventional, prospective, randomized, controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| REAnimation Patient Discomfort Questionnaire | 2 months | Overall score on the REAnimation Patient Discomfort Questionnaire at the end-of-study visit |
Countries
France
Contacts
CONTACTIgor LACOMBAT, MD
Outcome results
None listed