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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022028
Receipt No. R000025388
Scientific Title Effects of essential oil on delirium in ICU: a randomized controlled study.
Date of disclosure of the study information 2016/04/22
Last modified on 2016/04/22

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Basic information
Public title Effects of essential oil on delirium in ICU: a randomized controlled study.
Acronym Effects of essential oil on delirium in ICU
Scientific Title Effects of essential oil on delirium in ICU: a randomized controlled study.
Scientific Title:Acronym Effects of essential oil on delirium in ICU
Region
Japan

Condition
Condition delirium
Classification by specialty
Psychiatry Intensive care medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluated the effects of essential oil on delirium in ICU
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes a total Intensive Care Delirium Screening Checklist (ICDSC) score of >=4 and hyperactive in ICU staying
Key secondary outcomes a total ICDSC score of >=4 in ICU staying, dosage of sadatives, duration of mechanical ventilation, ICU length of stay, hospital length of stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 three drops of essential oil around the head at every 18:00 in a private room of ICU
Interventions/Control_2 normal care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria any patients admitted to ICU in emergency medical center of Fujisawa City Hospital
Key exclusion criteria children, pregnant women, use of non invasive ventilation, rejection of patients or families
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Miya
Organization Fujisawa City Hospital
Division name Fujisawa City Hospital
Zip code
Address 2-6-1 Fujisawa, Kanagawa 251-8550, Japan
TEL 0466-25-3111
Email miya.takuya@pref.saitama.lg.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Miya
Organization Fujisawa City Hospital
Division name Division of Emergency Medicine
Zip code
Address 2-6-1 Fujisawa, Kanagawa 251-8550, Japan
TEL 0466-25-3111
Homepage URL
Email miya.takuya@pref.saitama.lg.jp

Sponsor
Institute Division of Emergency Medicine, Fujisawa City Hospital
Institute
Department

Funding Source
Organization Division of Emergency Medicine, Fujisawa City Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 04 Month 30 Day
Date trial data considered complete
2016 Year 05 Month 15 Day
Date analysis concluded
2016 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 22 Day
Last modified on
2016 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025388

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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