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Management of Anxiety in Intensive Care Unit Including Olfactotherapy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04210635
Acronym
OCEAN
Enrollment
35
Registered
2019-12-26
Start date
2020-02-21
Completion date
2020-11-11
Last updated
2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Brief 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.

Detailed description

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

Interventions

OTHERZEN cart

essential oils + relaxing music + dim light

Sponsors

Laboratoires Arkopharma
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
measurement of the evolution of anxiety6 hoursThe 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026