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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036166
Receipt No. R000041205
Scientific Title The impact of continued aromatherapy from late pregnancy on mental health: A pilot study
Date of disclosure of the study information 2019/04/20
Last modified on 2019/03/12

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Basic information
Public title The impact of continued aromatherapy from late pregnancy on mental health: A pilot study
Acronym The impact of continued aromatherapy from late pregnancy on mental health: A pilot study
Scientific Title The impact of continued aromatherapy from late pregnancy on mental health: A pilot study
Scientific Title:Acronym The impact of continued aromatherapy from late pregnancy on mental health: A pilot study
Region
Japan

Condition
Condition Pregnant women
Classification by specialty
Obsterics and gynecology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the impact on mental health before and after parturition by continuing aromatherapy from late pregnancy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fear of birth
Key secondary outcomes labor pain
Anxiety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved 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 Self-administered aromatherapy from 38 weeks of pregnancy to 2 weeks after delivery.
Interventions/Control_2 Self-administered aromatherapy using placebo oil from 38 weeks of pregnancy to 2 weeks after delivery.
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
45 years-old >=
Gender Female
Key inclusion criteria 1) Low risk pregnant women after 28 weeks of pregnancy
2) Ability to read and write Japanese
Key exclusion criteria 1) Olfactory disorder
2) Smokes tobacco
3) History Of present illness of mental illness and endocrine disease
4) Food or drug allergies
5) Plant allergy or allergic symptoms with aromatherapy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kaori
Middle name
Last name Takahata
Organization St. Luke's International University, Graduate School
Division name Nursing science
Zip code 104-0044
Address 10-1, akashicho, Chuo-ku, Tokyo, 104-8560, Japan
TEL 03-3543-6391
Email kaoritakahata@slcn.ac.jp

Public contact
Name of contact person
1st name kaori
Middle name
Last name Takahata
Organization St. Luke's International University, Graduate School
Division name Nursing science
Zip code 104-0044
Address 10-1, Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan
TEL 03-3543-6391
Homepage URL
Email kaoritakahata@slcn.ac.jp

Sponsor
Institute St. Luke's International University
Institute
Department

Funding Source
Organization Mother & Child, Inc
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) MEXT KAKENHI (A)(Grant Number:17H01613)

IRB Contact (For public release)
Organization St. Luke's International University
Address 10-1, Akashi-cho, Chuo-ku, Tokyo, 104-8560, Japan
Tel 03-5550-2423
Email kenkyukikaku@luke.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 04 Month 20 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 20 Day
Last follow-up date
2021 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 03 Month 12 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041205

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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