Immersive Sensory Projections for Hospitalized Patients

NCT ID: NCT06577870

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2026-06-30

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.

Conditions

Hospitalism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Immersive sensory projections

Patients will benefit from an immersive sensory environment in the hospital room. This IHP immersive sensory environment consists of the following elements:

• light frescoes on the theme of nature, of the canopy type, diffused by a generative circadian cycle.
• a soundtrack made up of nature sounds and sounds of life outside the hospital, broadcast in an immersive (moving sounds in the room), random (non-repetitive sounds over time) and generative way.
• essential oils

Group Type: EXPERIMENTAL

Hospitalization in intensive care or continuing care unit

Intervention Type: PROCEDURE

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.

No immersive sensory projections

Standard (control) group: Patients will not have any Immersion Health Project-type immersive sensory projection in the hospital room.

Group Type: ACTIVE_COMPARATOR

Hospitalization in intensive care or continuing care unit

Intervention Type: PROCEDURE

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.

Interventions

Hospitalization 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Privé Jacques Cartier

Massy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Igor LACOMBAT, MD

Role: CONTACT

igor.lacombat@gmail.com

660406554 ext. +33

Facility Contacts

Igor LACOMBAT, MD

Role: primary

igor.lacombat@gmail.com

Other Identifiers

2024-A01322-45

Identifier Type: -

Identifier Source: org_study_id