UMIN-CTR Clinical Trial

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 Yoshiko Middle name Last name Ogawa
Organization	Teikyo University
Division name	Department of Sport and Medical Science, Faculty of Medical Technology
Zip code	192-0395
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 Yoshiko Middle name Last name Ogawa
Organization	Teikyo University
Division name	Department of Sport and Medical Science, Faculty of Medical Technology
Zip code	192-0395
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	The Ethics Committee of the Teikyo University
Address	2-11-1 Kaga, Itabashi-ku, Tokyo
Tel	+81-3-3964-7256
Email	turb-office@teikyo-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	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	24
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	2018 Year 09 Month 13 Day
Date of IRB	2018 Year 09 Month 13 Day
Anticipated trial start date	2018 Year 11 Month 19 Day
Last follow-up date	2022 Year 04 Month 27 Day
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	2022 Year 06 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039962