Immersive Sensory Projections for Hospitalized Patients

NCT06577870 | Recruiting

• 1 other identifier: 2024-A01322-45
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospitalism

Outcome Measures

Primary Outcomes (1)

• REAnimation Patient Discomfort Questionnaire

  Overall score on the REAnimation Patient Discomfort Questionnaire at the end-of-study visit

  2 months

Study Arms (2)

Immersive sensory projections

EXPERIMENTAL

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

No immersive sensory projections

ACTIVE COMPARATOR

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

Interventions

Hospitalization in intensive care or continuing care unit 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.

Immersive sensory projections; No immersive sensory projections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital Privé Jacques Cartier

Massy, 91300, France

RECRUITING

MeSH Terms

Interventions

Hospitalization; Critical Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Igor LACOMBAT, MD

CONTACT

660406554; igor.lacombat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, interventional, prospective, randomized, controlled study

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: May 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)