Management of Anxiety in Intensive Care Unit Including Olfactotherapy (OCEAN)

November 12, 2020 updated by: Laboratoires Arkopharma

Evaluation of a Comprehensive Approach in the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Laurent du Var, France
        • Institut Arnault Tzanck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The target population is made up of adult patients (aged over 18) hospitalized in the intensive care unit and expressing a complaint or presenting a state of anxiety during their hospitalization.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Arkopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2020

Primary Completion (Actual)

November 11, 2020

Study Completion (Actual)

November 11, 2020

Study Registration Dates

First Submitted

December 23, 2019

First Submitted That Met QC Criteria

December 23, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019- A01304-53

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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