Management of Anxiety in Intensive Care Unit Including Olfactotherapy

NCT ID: NCT04210635

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-21

Study Completion Date

2020-11-11

Brief Summary

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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.

Detailed Description

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

Conditions

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Anxiety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ZEN cart

essential oils + relaxing music + dim light

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires Arkopharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Arnault Tzanck

Saint-Laurent-du-Var, , France

Site Status

Countries

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France

Other Identifiers

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2019- A01304-53

Identifier Type: -

Identifier Source: org_study_id