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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000040422
Receipt No. R000046129
Scientific Title The relationship between the relaxing effect of the yuzu scent and sleep.
Date of disclosure of the study information 2020/06/01
Last modified on 2020/06/04

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Basic information
Public title The relationship between the relaxing effect of the yuzu scent and sleep.
Acronym The relationship between the relaxing effect of the yuzu scent and sleep.
Scientific Title The relationship between the relaxing effect of the yuzu scent and sleep.
Scientific Title:Acronym The relationship between the relaxing effect of the yuzu scent and sleep.
Region
Japan

Condition
Condition Healthy students
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between the relaxing effect of the scent of yuzu and sleep.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Salivary amylase level and questionnaire for assessing sleep
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Sleep under the scent of yuzu
Interventions/Control_2 Sleep in an unscented situation
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
20 years-old <=
Age-upper limit
24 years-old >=
Gender Male and Female
Key inclusion criteria 1. Those who receive an appropriate explanation of the purpose and content of the study, are able to consent, voluntarily request to participate after gaining a full understanding, and are able to consent to participation in this survey in writing.
2. Healthy individuals
Key exclusion criteria 1. Individuals who do not like the citrus scent.
2. Individuals taking drugs that affect the autonomic nervous system.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Shunji
Middle name
Last name Mizobuchi
Organization Kochi Medical School, Kochi University
Division name Clinical nursing
Zip code 783-8505
Address Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL 088-880-2564
Email mizoshun@kochi-u.ac.jp

Public contact
Name of contact person
1st name shunji
Middle name
Last name Mizobuchi
Organization Kochi University
Division name Clinical nursing, Kochi Medical School
Zip code 783-8505
Address Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL 088-880-2564
Homepage URL
Email mizoshun@kochi-u.ac.jp

Sponsor
Institute Kochi University
Institute
Department

Funding Source
Organization Kochi University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kochi Medical School, Center for Next Generation Medicine
Address Kohasu,Oko-cho,Nankoku-city,Kochi,Japan
Tel 088-880-2719
Email im62@kochi-u.ac.jp

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
2020 Year 06 Month 01 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 Terminated
Date of protocol fixation
2020 Year 05 Month 30 Day
Date of IRB
2020 Year 05 Month 26 Day
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2020 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 17 Day
Last modified on
2020 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046129

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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