UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017830 |
|---|---|
| Receipt number | 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 | 2024/09/06 11:03:21 |
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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
| Obstetrics 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 | Shigeko |
| Middle name | |
| Last name | Horiuchi |
Organization
St. Luke's International University
Division name
Nursing science, Women's Health & Midwifery
Zip code
104-0044
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan
TEL
03-3543-6391
shigeko-horiuchi@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Tadokoro |
Organization
St. Luke's International University, Postgraduate School
Division name
Nursing science, Women's Health & Midwifery
Zip code
104-0045
Address
3-8-5, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL
03-6226-6361
Homepage URL
14dn011@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
MEXT KAKENHI (B)(Grant Number: 26293475)
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Research Ethics Committee, St.Luke's International University
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan
Tel
03-3543-6391
-
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
Published
Result
URL related to results and publications
https://bmcresnotes.biomedcentral.com/articles/10.1186/s13104-017-3053-3
Number of participants that the trial has enrolled
11
Results
Oxytocin level increased in 2 participants, decreased in 2, and was unmeasurable in 2. Uterine contraction was not observed in both groups. Regarding practicality, 3 of the 11 participants could not collect sufficient saliva. The cortisol level decreased in both groups. The protocol had no negative effects. Regarding acceptability, burden of the protocol was not observed.
Results date posted
| 2024 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cf.https://bmcresnotes.biomedcentral.com/articles/10.1186/s13104-017-3053-3
Participant flow
Cf.https://bmcresnotes.biomedcentral.com/articles/10.1186/s13104-017-3053-3
Adverse events
Cf.https://bmcresnotes.biomedcentral.com/articles/10.1186/s13104-017-3053-3
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
| 2015 | Year | 05 | Month | 29 | Day |
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
| 2024 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020654
