UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037398
Receipt number R000042638
Scientific Title The relation between using clary sage essential oil infused in a footbath and the timing of labor onset: a randomized feasibility study
Date of disclosure of the study information 2019/07/17
Last modified on 2020/07/17 09:11:31

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Basic information

Public title

Using clary sage essential oil infused in a footbath and the timing of labor onset

Acronym

Clary sage essential oil infused in a footbath and the timing of labor onset

Scientific Title

The relation between using clary sage essential oil infused in a footbath and the timing of labor onset: a randomized feasibility study

Scientific Title:Acronym

Clary sage essential oil infused in a footbath and the timing of labor onset

Region

Japan


Condition

Condition

Post-term delivery

Classification by specialty

Obstetrics and Gynecology Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the feasibility of the randomized pilot study aimed to examine the effects on the readiness to labor onset.

Basic objectives2

Others

Basic objectives -Others

The feasibility of the randomized pilot study aimed to examine the effects on the readiness to labor onset.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The feasibility of the randomized pilot study (Demand, acceptability, implementation, practicality, process, resources, and management).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Using clary sage and lavender essential oils infused in a footbath for 20 minutes, twice a day.

Interventions/Control_2

Usual care

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Low risk pregnant women who are more than or 39 weeks of gestation before labor onset and plan to give birth with spontaneous vaginal delivery.

Key exclusion criteria

High risk pregnancy (multiple pregnancy, history of caesarian section and stillbirth, complications of pregnancy or fetus)
Olfactory disorder
Mental disorder
Allergy with plants or aromatherapy
Some allergies of food or drug

Target sample size

30


Research contact person

Name of lead principal investigator

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

TEL

047-495-7751

Email

y-tadokoro@thcu.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

TEL

047-495-7751

Homepage URL


Email

y-tadokoro@thcu.ac.jp


Sponsor or person

Institute

Tokyo Healthcare University

Institute

Department

Personal name



Funding Source

Organization

JSPS KAKENHI

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Healthcare University

Address

4 Chome-1-17 Higashigotanda, Shinagawa City, Tokyo

Tel

03-5421-7655

Email

kenkyo@thcu.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

2019 Year 07 Month 17 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

2019 Year 06 Month 14 Day

Date of IRB

2019 Year 06 Month 14 Day

Anticipated trial start date

2019 Year 07 Month 18 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 07 Month 17 Day

Last modified on

2020 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042638


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name