Management of Anxiety in Intensive Care Unit Including Olfactotherapy

Anxiety Clinical Trial

— OCEAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210635
• Other study ID #: 2019- A01304-53
• Status: Completed
• Start date: February 21, 2020
• Est. completion date: November 11, 2020

Study information

• Verified date: November 2020
• Source: Laboratoires Arkopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 11, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• ZEN cart
essential oils + relaxing music + dim light

Locations

Country	Name	City	State
France	Institut Arnault Tzanck	Saint-Laurent du Var

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Arkopharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of the evolution of anxiety	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