Using sensory elements to reduce discomfort in ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hôpital Privé Jacques Cartier
  Massy, France Recruiting

Study contacts

• Study coordinator: Igor LACOMBAT, MD
• Email: igor.lacombat@gmail.com
• Phone: 660406554

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.