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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025786
Receipt No. R000029653
Scientific Title Effects of a "Relaxed Aromatherapy Sheet" Attached to a Microcapsule that Contains Lavender Oil on Sleep
Date of disclosure of the study information 2017/01/23
Last modified on 2017/12/26

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Basic information
Public title Effects of a "Relaxed Aromatherapy Sheet" Attached to a Microcapsule that Contains Lavender Oil on Sleep
Acronym Effects of a "Relaxed Aromatherapy Sheet" Attached to a Microcapsule that Contains Lavender Oil on Sleep
Scientific Title Effects of a "Relaxed Aromatherapy Sheet" Attached to a Microcapsule that Contains Lavender Oil on Sleep
Scientific Title:Acronym Effects of a "Relaxed Aromatherapy Sheet" Attached to a Microcapsule that Contains Lavender Oil on Sleep
Region
Japan

Condition
Condition Healthy females aged 20-29 years
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to determine the effects of a "relaxed aromatherapy sheet" attached to a microcapsule that contains lavender oil on sleep.
Basic objectives2 Others
Basic objectives -Others The objective of this study is to determine the effects of a "relaxed aromatherapy sheet" attached to a microcapsule that contains lavender oil on sleep.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes sleep latency
Key secondary outcomes Objective valuation; total sleep time, sleep efficiency, sleep minutes and wake minutes
Subjective valuation; feeling of sound sleep, perceived sleep quality

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 Subjects use "relaxed aromatherapy sheets" attached to a microcapsule that contains lavender oil when they lie down for sleep for 5 days.
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 The subjects can keep a regular bedtime and awake time hour (variation of error ; one hour)for 10 days
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 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoe Yokono
Organization Niigata university
Division name Faculty of Medicine, School of Health Sciences
Zip code
Address 2-746 Asahimachi-dori, Chuo-ku, Niigata
TEL 025-227-0940
Email 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 Faculty of Medicine, School of Health Sciences
Zip code
Address 2-746 Asahimachi-dori, Chuo-ku, Niigata
TEL 025-227-0940
Homepage URL
Email tyokono@clg.niigata-u.ac.jp

Sponsor
Institute Niigata university,Faculty of Medicine, School of Health Sciences
Institute
Department

Funding Source
Organization Haatohuruatago company
Organization
Division
Category of Funding Organization Profit organization
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 新潟大学

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 23 Day

Related information
URL releasing protocol
Publication of results Partially published

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 11 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 23 Day
Last follow-up date
2017 Year 04 Month 30 Day
Date of closure to data entry
2017 Year 10 Month 31 Day
Date trial data considered complete
2017 Year 10 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 21 Day
Last modified on
2017 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029653

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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