UMIN-CTR Clinical Trial

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

Pregnant women between 38 and 40 weeks of gestation.

Classification by specialty

Obstetrics and Gynecology	Nursing	Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

shigeko-horiuchi@slcn.ac.jp

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

Email

14dn011@slcn.ac.jp

Institute

St. Luke's International University

Institute

Department

Personal name

Organization

MEXT KAKENHI (B)(Grant Number: 26293475)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Fumiko Yamaji grant in aid for Nursing research

Organization

IRB, St. Luke's International University

Address

10-1, Akashicho, Chuo-ku, Tokyo

Tel

03-3543-6391

Email

kenkyurinri@slcn.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

聖路加産科クリニック(東京都)

Date of disclosure of the study information

2016

Year

02

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

02

Month

08

Day

Last modified on

2022

Year

08

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023980