NCT04210635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 21, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

December 23, 2019

Last Update Submit

November 12, 2020

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

ZEN cartOTHER

essential oils + relaxing music + dim light

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Arnault Tzanck

Saint-Laurent-du-Var, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2019

First Posted

December 26, 2019

Study Start

February 21, 2020

Primary Completion

November 11, 2020

Study Completion

November 11, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

FR(1)