UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022028 |
|---|---|
| Receipt number | 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 16:48:55 |
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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
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
miya.takuya@pref.saitama.lg.jp
Sponsor or person
Institute
Division of Emergency Medicine, Fujisawa City Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025388
