Clinical trial NCT06577870: Immersive Sensory Projections for Hospitalized Patients
Official title: Immersive Sensory Projections: Evaluating the Impact of an Immersive Sensory Environment (Visual, Auditory and Olfactory) on Reducing the Overall Discomfort of Patients Hospitalized in the Resuscitation and Continuing Care Units
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hospitalism
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2024-08-29
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, interventional, prospective, randomized, controlled study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: REAnimation Patient Discomfort Questionnaire
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
Study officials:
References: