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
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
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
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
