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NCT Number: NCT06577870

Immersive Sensory Projections for Hospitalized Patients

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location status: Recruiting

Location contact

Igor LACOMBAT, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. REAnimation Patient Discomfort Questionnaire

    Time frame: 2 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Igor LACOMBAT, MD

CONTACT

[email protected]

660406554 ext. +33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study title

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

Acronym: IHP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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