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Completed

NCT Number: NCT04210635

Management of Anxiety in Intensive Care Unit Including Olfactotherapy

The OCEAN observational study is a pilot study. The aim is to validate the interest of the intervention of essential oils, relaxing music and dim light on the anxiety of patient who are in the intensive care unit.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Arnault Tzanck

Saint-Laurent-du-Var, France

About this study

The primary endpoint is a numeric scale varying from 0 (no anxiety) to 10 (anxiety maximum).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hospitalized in one of the departments participating in the study
  • Presenting moderate to high intensity anxiety (Digital scale ≥ 5);

Exclusion criteria

  • Having already benefited from the "ZEN cart"
  • Having taken an anxiolytic during the past 48 hours
  • Patient (s) intubated and / or sedated
  • Allergy or known intolerance to one of the essential oils used
  • Respiratory allergies, asthma, or a history of seizures
  • Unable to understand the information note (linguistic reason, or related to his medical condition)
  • Pregnant or lactating woman.

Treatment and study plan

ZEN cart

Other

essential oils + relaxing music + dim light

Primary outcomes

  1. measurement of the evolution of anxiety

    Time frame: 6 hours

    The main objective of this study is to measure the evolution of the patient's anxiety between H0 (start of a "ZEN cart" session) and H6 (end of the "ZEN cart" session).

Sponsors and collaborators

Lead sponsor

Laboratoires Arkopharma

Industry

Registry information

Official study title

Evaluation of a Comprehensive Approach in the Management of Anxiety in Intensive Care Unit Including Olfactotherapy

Acronym: OCEAN

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 26, 2019
Registry last updated
Nov 13, 2020

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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