UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020933 |
|---|---|
| Receipt number | R000023980 |
| Scientific Title | Effects on Salivary Oxytocin Using a Foot Bath Infused with Clary Sage and Lavender or Jasmine for Inducing Labor. |
| Date of disclosure of the study information | 2016/02/09 |
| Last modified on | 2024/09/06 10:52:36 |
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Basic information
Public title
Effects on Salivary Oxytocin Using a Foot Bath Infused with Clary Sage and Lavender or Jasmine for Inducing Labor.
Acronym
Effects on Salivary Oxytocin Using a Foot Bath with Aromatherapy Essential Oil.
Scientific Title
Effects on Salivary Oxytocin Using a Foot Bath Infused with Clary Sage and Lavender or Jasmine for Inducing Labor.
Scientific Title:Acronym
Effects on Salivary Oxytocin Using a Foot Bath with Aromatherapy Essential 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
NO
Objectives
Narrative objectives1
Comparing the salivary oxytocin change between aroma footbath with A. clary sage and lavender, or B. Jasmin, and footbath C. without any essential oil, and verifying the feasibility of the experimental approach.
Hypotheses:
1. The level of oxytocin after the footbath with A. and B. is higher than before.
2. The increase of oxytocin from before to after footbath with A. and B. is greater than that of foot bath with C.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
The change of salivary oxytocin between before and after foot-bath.
Key secondary outcomes
1. The change of salivary cortisol between before and after foot-bath
2. Uterine contraction
3. Delivery outcomes (spontaneous labor/ oxytocin use to induce labor, gestational week of delivery, the length from experiment to the birth, the delivery mode, oxytocin use to augment labor, gender of the baby)
4. Side effects from using the essential oils(fetal heart rate abnormalities, cutis symptom, premature rupture of membranes, apgar score at 5 minutes, NICU admissions)
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
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Footbath with A. Clary sage and lavender for 20 minutes and saliva collection before and after the footbath.
Interventions/Control_2
Footbath with B. Jasmine for 20 minutes and saliva collection before and after the footbath.
Interventions/Control_3
Footbath with C. no any essential oil for 20 minutes and saliva collection before and after the footbath
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1. 38 weeks of gestation through 40 weeks of gestation
2. Plan to give birth with spontaneous delivery
3. Before the onset of labor
4. Ability to 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. Smokes tobacco
7. Drinks alcoholic
8. Complications of pregnancy
9. Hospital visits or follow up for complication not related to gestation
10. Food or drug allergies
11. Plant allergy or allergic symptoms with aromatherapy
12. Breast feeding child
13. Olfactory disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shigeko |
| Middle name | |
| Last name | Horiuchi |
Organization
St. Luke's International University, Postgraduate School
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
Tokyo Healthcare University
Division name
Chiba Faculty of Nursing
Zip code
273-8710
Address
1-1042-2 Kaijincho nishi, Funabashi-shi, Chiba 273-8710, Japan
TEL
047-495-7751
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
IRB, St. Luke's International University
Address
10-1, Akashicho, Chuo-ku, Tokyo
Tel
03-3543-6391
kenkyurinri@slcn.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
聖路加産科クリニック(東京都)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/1660-4601/20/13/6262
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/1660-4601/20/13/6262
Number of participants that the trial has enrolled
82
Results
cf. https://www.mdpi.com/1660-4601/20/13/6262
Results date posted
| 2024 | Year | 09 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
cf. https://www.mdpi.com/1660-4601/20/13/6262
Participant flow
cf. https://www.mdpi.com/1660-4601/20/13/6262
Adverse events
cf. https://www.mdpi.com/1660-4601/20/13/6262
Outcome measures
cf. https://www.mdpi.com/1660-4601/20/13/6262
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 08 | 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=R000023980
