Immersive Sensory Projections for Hospitalized Patients (IHP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hospitalism
• Intervention / Treatment: Procedure: Hospitalization in intensive care or 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.

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Igor LACOMBAT, MD; Phone Number: +33 660406554; Email: igor.lacombat@gmail.com

Study Locations

• France
  • Massy, France, 91300
    • Recruiting
    • Hôpital Privé Jacques Cartier
    • Contact: Igor LACOMBAT, MD; Email: igor.lacombat@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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.
Active Comparator: No immersive sensory projections; Standard (control) group: Patients will not have any Immersion Health Project-type immersive sensory projection in the hospital room.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
REAnimation Patient Discomfort Questionnaire	Overall score on the REAnimation Patient Discomfort Questionnaire at the end-of-study visit	2 months

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-A01322-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No