UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025787 |
|---|---|
| Receipt number | R000028081 |
| Scientific Title | Detection of Sleep-improving Essential Oil Volume Present in a Microcapsule |
| Date of disclosure of the study information | 2017/01/21 |
| Last modified on | 2017/01/21 13:09:02 |
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Basic information
Public title
Detection of Sleep-improving Essential Oil Volume Present in a Microcapsule
Acronym
Detection of Sleep-improving Essential Oil Volume Present in a Microcapsule
Scientific Title
Detection of Sleep-improving Essential Oil Volume Present in a Microcapsule
Scientific Title:Acronym
Detection of Sleep-improving Essential Oil Volume Present in a Microcapsule
Region
| Japan |
Condition
Condition
Healthy adult females
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to detect the smell sensitivity threshold volume of essential oil present in a microcapsule. This primary study aimed to determine the effects of a "relaxed aromatherapy sheet" attached to a microcapsule that contains lavender oil on sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency of rolling over in bed when subjects detected whiff in the relaxed aromatherapy sheets.
Key secondary outcomes
Feeling by rolling over in bed when subjects detected whiff in the relaxed aromatherapy sheets.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
a "relaxed aromatherapy sheet" attached to small or moderate amount of microcapsules that contains lavender oil.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Healty
Key exclusion criteria
1.Difficult smelling
2.Difficult resting supine and lateral position
3.Cognitive impairment
4.A person with a history of allergies (gelatin, lavender)
5.A feeling of unwellness (cold)
6.Disorder of sleep
7.Physically and mentally sick
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoe Yokono |
Organization
Niigata University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
Address
2-746 Asahimachi-dori, Chuo-ku, Niigata
TEL
025-227-0940
tyokono@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoe Yokono |
Organization
Niigata University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
Address
2-746 Asahimachi-dori, Chuo-ku, Niigata
TEL
025-227-0940
Homepage URL
tyokono@clg.niigata-u.ac.jp
Sponsor or person
Institute
School of Health Sciences, Faculty of Medicine, Niigata University
Institute
Department
Personal name
Funding Source
Organization
Haatohuruatago Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
新潟大学
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 21 | 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
| 2016 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 21 | Day |
Last modified on
| 2017 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028081
