UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of essential oil on delirium in ICU: a randomized controlled study.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Takuya Miya
Organization	Fujisawa City Hospital
Division name	Fujisawa City Hospital
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	Takuya Miya
Organization	Fujisawa City Hospital
Division name	Division of Emergency Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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