Using sensory elements to reduce discomfort in ICU patients

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

This study tests if using calming sights, sounds, and smells can help make ICU patients feel more comfortable while they receive their usual care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 208 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche (Academic / other)
• Locations: 1 site (Massy)
• Trial ID: NCT06577870 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of immersive sensory projections, including visual, auditory, and olfactory stimuli, on alleviating discomfort in patients admitted to intensive care or continuing care units. It is a multicenter, interventional, prospective, randomized, controlled, open-label study involving adult patients who are either conscious or under mechanical ventilation. Participants will receive standard care while being monitored by the medical team, and the study will be introduced to them or their trusted support person upon hospital admission.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are hospitalized in intensive care or continuing care units for at least 48 hours.

Not a fit: Patients who are deaf, blind, or have specific medical conditions such as asthma or epilepsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the comfort and overall experience of patients in intensive care settings.

How similar studies have performed: While the specific combination of sensory elements is novel, similar studies have shown that sensory interventions can improve patient comfort in hospital settings.

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.

Where this trial is running

Massy

• Hôpital Privé Jacques Cartier — Massy, France (Recruiting)

Study contacts

• Study coordinator: Igor LACOMBAT, MD

Conditions Hospitalism