UMIN-CTR Clinical Trial

Basic information
Public title	A study on psychological effects of mothers and children by postpartum life intervention
Acronym	Postpartum female life intervention
Scientific Title	A study on psychological effects of mothers and children by postpartum life intervention
Scientific Title:Acronym	Postpartum female life intervention
Region	Japan

Condition
Condition	healthy women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We conduct intervention by horticultural therapy for healthy women after childbirth and We will clarify the effects on mental health and cognitive function of mothers caused by horticultural intervention and psychological effects on mothers' children who received intervention. Furthermore, it aims to clarify the possibility as an effective psychological support method for improving postpartum depression.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	change rate of EPDS score
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	horticultural therapy intervention (2 months)
Interventions/Control_2
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	18 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	- Women within 1 year after childbirth - The native Japanese language - Those who agree in writing to participate in this study
Key exclusion criteria	- Women who passed one year or more after childbirth - Japanese is not a native language - Those who judge that the research director is inappropriate for participation - Those who can not obtain consent to participate in this study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yuka Middle name Last name Kotozaki
Organization	Iwate Tohoku Medical Megabank Organization, Iwate Medical University
Division name	Division of Clinical Research and Epidemiology
Zip code	0283694
Address	2-1-1, Nishitokuta, Yahaba, Iwate, 028-3694, Japan
TEL	019-651-5110
Email	kotoyuka@iwate-med.ac.jp

Public contact
Name of contact person	1st name Yuka Middle name Last name Kotozaki
Organization	Iwate Tohoku Medical Megabank Organization, Iwate Medical University
Division name	Division of Clinical Research and Epidemiology
Zip code	0283694
Address	2-1-1, Nishitokuta, Yahaba, Iwate, 028-3694, Japan
TEL	019-651-5110
Homepage URL
Email	kotoyuka@iwate-med.ac.jp

Sponsor
Institute	Iwate Medical University
Institute
Department

Funding Source
Organization	Private school foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Iwate Medical University
Address	2-1-1, Nishitokuta, Yahaba, Iwate, 028-3694, Japan
Tel	0196515110
Email	kotoyuka@iwate-med.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	2018 Year 10 Month 01 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	2018 Year 07 Month 05 Day
Date of IRB	2018 Year 09 Month 24 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2019 Year 05 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	2018 Year 09 Month 30 Day
Last modified on	2020 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038098