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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017830
Receipt No. R000020654
Scientific Title Longitudinal Changes of Salivary Oxytocin and Salivary Cortisol after Inhalation of Clary Sage Essential Oil Vapors: Preliminary Study
Date of disclosure of the study information 2015/06/08
Last modified on 2016/02/08

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Basic information
Public title Longitudinal Changes of Salivary Oxytocin and Salivary Cortisol after Inhalation of Clary Sage Essential Oil Vapors: Preliminary Study
Acronym Longitudinal changes of Oxytocin after Clary Sage Oil
Scientific Title Longitudinal Changes of Salivary Oxytocin and Salivary Cortisol after Inhalation of Clary Sage Essential Oil Vapors: Preliminary Study
Scientific Title:Acronym Longitudinal changes of Oxytocin after Clary Sage Oil
Region
Japan

Condition
Condition Pregnant women between 38 and 40 weeks of gestation
Classification by specialty
Obsterics and gynecology Nursing Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 1) To examine the longitudinal changes of salivary oxytocin and salivary cortisol after inhalation of clary sage essential oil vapor.
2) To verify and confirm the feasibility of the experimental approach.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Salivary oxytocin 10 minutes before intervention and 15, 30, 60 minutes after intervention
Key secondary outcomes Salivary cortisol 10 minutes before intervention and 15, 30, 60 minutes after intervention,
Polymorphisms of oxytocin receptor

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Interventions:
Vapor bubbles are produced from clary sage essential oil dissolved in propylene glycol by an air pump. Subjects inhale the vapor for 20 minutes through a tube and funnel near their nostrils
Interventions/Control_2 Control:
Subjects inhale the air pumped with only propylene glycol for 20 minutes through tube and funnel near their nostrils
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
25 years-old <=
Age-upper limit
35 years-old >=
Gender Female
Key inclusion criteria 1. Low risk singleton pregnant women who are 38 weeks of gestation through 40 weeks of gestation
2. Plan to give birth with spontaneous delivery
3. Before the onset of labor
4. Asian and can read and write Japanese

Key exclusion criteria 1. Experienced prolonged pregnancy
2. Previous caesarian section
3. Recurrent miscarriages (3 consecutive)
4. Medical history of treatment of infertility
5. Planned induced labor or cesarean section
6. Planned analgesia
7. Smokes tobacco
8. Alcoholic
9. Complications of pregnancy
10. Takes medication not to related to gestation
11. Hospital visits for complication not related to gestation
12. Medical history that needs treatment or follow up
13. Some allergies of food or drug
14. Plant allergy or allergic symptoms with aromatherapy
15. Breast feeding child
16. Olfactory disorder
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeko Horiuchi
Organization St. Luke's International University
Division name Nursing science, Women's Health & Midwifery
Zip code
Address 10-1, Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan
TEL 03-3543-6391
Email shigeko-horiuchi@slcn.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuriko Tadokoro
Organization St. Luke's International University, Postgraduate School
Division name Nursing science, Women's Health & Midwifery
Zip code
Address 3-8-5, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL 03-6226-6361
Homepage URL
Email 14dn011@slcn.ac.jp

Sponsor
Institute St. Luke's International University
Institute
Department

Funding Source
Organization MEXT KAKENHI (B)(Grant Number: 26293475)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Fumiko Yamaji grant in aid for Nursing research

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
2015 Year 06 Month 08 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
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 09 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
2015 Year 08 Month 31 Day
Date trial data considered complete
2015 Year 08 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 06 Day
Last modified on
2016 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020654

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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