UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036166 |
|---|---|
| Receipt number | 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 | 2022/03/04 11:28:39 |
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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
| Obstetrics 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
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
kaoritakahata@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
JSPS Grant-in-Aid for Research Activity Start-up (Grant Number:20K23174)
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
St. Luke's International University
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, 104-8560, Japan
Tel
03-5550-2423
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
42
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 | 03 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 12 | Day |
Last modified on
| 2022 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041205
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
