UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034331
Receipt number R000038098
Scientific Title A study on psychological effects of mothers and children by postpartum life intervention
Date of disclosure of the study information 2018/10/01
Last modified on 2020/04/01 09:29:48

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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 or person

Institute

Iwate Medical University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038098


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name