UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048932
Receipt number R000054865
Scientific Title A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women.
Date of disclosure of the study information 2022/09/14
Last modified on 2022/09/14 10:12:31

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Basic information

Public title

A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women.

Acronym

A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women.

Scientific Title

A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women.

Scientific Title:Acronym

A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women.

Region

Japan


Condition

Condition

Postpartum depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the effects of continuous use of the childcare support service (communication robot (BOCCO emo)) from pregnancy to postpartum on quality of life and prevent and improve depressive condition, and to conduct a feasibility investigation of the service.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

WHO-5(simplified Japanese version of the WHO-Five Well-being Index) change in total score from baseline to each time point(36 weeks gestation, 1 and 3 months postpartum).

Key secondary outcomes

(1)EPDS(Edinburgh Postnatal Depression Scale) change in total score from baseline to each time point.
(2)Number of consultations with local maternal and child health centers(36 weeks gestation, 1 and 3 months postpartum).
(3)Satisfaction with overall service, continued use, recommendation, frequency of use, intention to pay for service, financial knowledge and insurance consultation needs based on questionnaire responses regarding service, etc.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

The intervention group will receive the communication robot (BOCCO emo) at 30 weeks of pregnancy after consent is confirmed, and the intervention will start as soon as it arrives. The service will continue to be available until 3 months after delivery. In addition to the parenting support services, online counseling (up to 2 times), online midwife/nursery consultation (up to 2 times), and online medical care (free of charge up to the appointment, actual cost for medical care) are also available. The frequency of use and services can be selected according to the preferences of the research subjects.

Interventions/Control_2

The control group will not use the parenting support services.

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


Not applicable

Gender

Female

Key inclusion criteria

Persons who meet all of the following criteria will be considered for this study.
(1) The women who are in the second trimester of pregnancy and pregnant with their first child at the time of obtaining consent.
(2) Persons who agree with the content of this study and have given their consent to participate in the study.
(3) Have a Wi-Fi environment at home and be able to set up the communication robot at home and connect to Wi-Fi throughout the study period.
(4) Persons who are able to download and use the dedicated application on their own smartphones.
(5) Persons who can understand the Japanese language described in the consent document and the questionnaire.

Key exclusion criteria

Persons who meet any of the following criteria will be excluded from this study.
(1) Persons who require a surrogate.
(2) Persons who plan to live with their mother, father, mother-in-law, father-in-law, or supporter during the first 3 months after childbirth.
(3) Persons who are under treatment for depression or psychiatric disorders.
(4) Other persons who are judged to be inappropriate to participate in this study by the principal investigator or co-Investigators.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoshiyuki
Middle name
Last name Tachibana

Organization

National Center for Child Health and Development

Division name

Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine

Zip code

1578535

Address

2-10-1 Okura,Setagaya-ku,Tokyo

TEL

03-3416-0181

Email

tachibana-y@ncchd.go.jp


Public contact

Name of contact person

1st name Miwa
Middle name
Last name Takai

Organization

National Center for Child Health and Development

Division name

Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine

Zip code

1578535

Address

2-10-1 Okura,Setagaya-ku,Tokyo

TEL

03-3416-0181

Homepage URL


Email

boccoemo@ncchd.go.jp


Sponsor or person

Institute

National Center for Child Health and Development

Institute

Department

Personal name



Funding Source

Organization

SUMITOMO LIFE INSURANCE COMPANY

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Review Board, National Center for Child Health and Development

Address

2-10-1 Okura,Setagaya-ku,Tokyo

Tel

03-3416-0181

Email

rinri@ncchd.go.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

国立成育医療研究センター(東京都)


Other administrative information

Date of disclosure of the study information

2022 Year 09 Month 14 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

2022 Year 09 Month 08 Day

Date of IRB

2022 Year 09 Month 08 Day

Anticipated trial start date

2022 Year 09 Month 15 Day

Last follow-up date

2023 Year 12 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

2022 Year 09 Month 14 Day

Last modified on

2022 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054865


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name