AnxietyOCEANNCT04210635
Management of Anxiety in Intensive Care Unit Including Olfactotherapy
An observational study of Anxiety, run by Laboratoires Arkopharma at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- ZEN cart
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2020to 11 Nov 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Hospitalized in one of the departments participating in the study
- Presenting moderate to high intensity anxiety (Digital scale ≥ 5);
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The primary endpoint is a numeric scale varying from 0 (no anxiety) to 10 (anxiety maximum).
- Conditions
- Anxiety
- Being tested
- ZEN cart
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEN cartOther
essential oils + relaxing music + dim light
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start21 Feb 2020
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Laboratoires Arkopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210635
- Sponsor's protocol ID
- 2019- A01304-53
- Acronym
- OCEAN
- Status last verified
- Nov 2020
- First submitted
- 23 Dec 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Comprehensive Approach in the Management of Anxiety in Intensive Care Unit Including Olfactotherapy
- ClinicalTrials.gov ID
- NCT04210635
- Acronym / sponsor ID
- OCEAN / 2019- A01304-53
- Conditions
- Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Laboratoires ArkopharmaIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- Hospitalized in one of the departments participating in the study
- Presenting moderate to high intensity anxiety (Digital scale ≥ 5);
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZEN cartessential oils + relaxing music + dim light | Other | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Laboratoires Arkopharma at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of the evolution of anxiety (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.