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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035051
Receipt No. R000039962
Scientific Title Does aromatherapy during sleep using aromatized patch reduce physiological and psychological stress?
Date of disclosure of the study information 2018/11/28
Last modified on 2018/11/28

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Basic information
Public title Does aromatherapy during sleep using aromatized patch reduce physiological and psychological stress?
Acronym Does aromatherapy during sleep using aromatized patch reduce physiological and psychological stress?
Scientific Title Does aromatherapy during sleep using aromatized patch reduce physiological and psychological stress?
Scientific Title:Acronym Does aromatherapy during sleep using aromatized patch reduce physiological and psychological stress?
Region
Japan

Condition
Condition Healty adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate whether aromatherapy during sleep using aromatized patch can reduce physiological and psychological stress
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Salivary cortisol after 1-nignt and 7-night intervention
Key secondary outcomes Salivary amylase, Profile of Mood States 2nd Edition (POMS 2), OSA sleep inventory MA version and pulse rate right after getting up after 1-nignt and 7-night intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Intervention group: Put an lavender-aromatized patch on nightwear and sleep over 7 nights
Interventions/Control_2 Control group: Put a fragrance-free patch on nightwear and sleep over 7 nights
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adult
Key exclusion criteria person who do aromatherapy routinely
smoker
women who are or may be pregnant
nursing mother
person who work the night shift
person who are receiving some medical treatment at present
person who take some sleeping drug
person who have allergies to lavender or orange
person who have allergic reaction or feeling of unwellness to aromatherapy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ogawa Yoshiko
Organization Teikyo University
Division name Department of Sport and Medical Science, Faculty of Medical Technology
Zip code
Address 359 Otsuka, Hachioji-shi, Tokyo, 192-0395 Japan
TEL +81-42-690-2769
Email yogawa@main.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ogawa Yoshiko
Organization Teikyo University
Division name Department of Sport and Medical Science, Faculty of Medical Technology
Zip code
Address 359 Otsuka, Hachioji-shi, Tokyo, 192-0395 Japan
TEL +81-42-690-2769
Homepage URL
Email yogawa@main.teikyo-u.ac.jp

Sponsor
Institute Department of Sport and Medical Science, Faculty of Medical Technology, Teikyo University
Institute
Department

Funding Source
Organization Teikyo 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
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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 28 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 28 Day
Last modified on
2018 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039962

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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