Management of Anxiety in Intensive Care Unit Including Ol... | NCT04210635

Studies
Management of Anxiety in Intensive Care Unit Including Olfactotherapy

NCT04210635

Sponsor

Laboratoires Arkopharma

Status

Completed

Last Update Posted

Nov 13, 2020Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Anxiety

Interventions

ZEN cart

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2020Actual

Primary Completion Date

Nov 11, 2020Actual

Completion Date

Nov 11, 2020Actual

First Submitted Date

Dec 23, 2019

First Submission Date that Met QC Criteria

Dec 23, 2019

First Posted Date

Dec 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2020

Last Update Posted Date

Nov 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Name	Type	Description	Arm Group Labels	Other Names
ZEN cart	Other	essential oils + relaxing music + dim light

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Arnault Tzanck		Saint-Laurent-du-Var			France