UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052638 |
|---|---|
| Receipt number | R000060064 |
| Scientific Title | Development of an application to connect infant mat-typed device and the effect of device use on reducing mothers' childrearing anxiety. |
| Date of disclosure of the study information | 2023/10/27 |
| Last modified on | 2023/10/27 16:27:25 |
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Basic information
Public title
Development of an application to connect infant mat-typed device and the effect of device use on reducing mothers' childrearing anxiety.
Acronym
Development of infant mat-typed device and connected application and their effectiveness in childrearing.
Scientific Title
Development of an application to connect infant mat-typed device and the effect of device use on reducing mothers' childrearing anxiety.
Scientific Title:Acronym
Development of infant mat-typed device and connected application and their effectiveness in childrearing.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Nursing | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop an infant mat-typed device capable of monitoring the biometric data and its connected application software and to verify their effectiveness in reducing mothers' childraring anxiety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mood Status
Key secondary outcomes
Depression, Quality of sleep
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants in the intervention group will use the developed mat-type device and linked app for one month.
Interventions/Control_2
Participants in the control group will not use the device and app.
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
1.Mothers raising 3-6 month-old children.
2. The Participants who have agreed to participate in this study.
3.The participants who attend all survey.
Key exclusion criteria
1. Mothers who do not live with their eligible children.
2.Mothers who are unable to participate in the survey because of the subject child's or their own illness.
3.Those who do not have sufficient ability in Japanese to participate in this survey.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Watanabe |
Organization
Osaka University
Division name
Graduate School of Medicine, Health Science
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2520
watanabe@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Watanabe |
Organization
Osaka University
Division name
Graduate School of Medicine, Health Science
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2520
Homepage URL
watanabe@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Aoyama Gakuin University, Kobe University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Research Review Committee
Address
2-2 Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.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
| 2023 | Year | 10 | Month | 27 | 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
| 2023 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2023 | Year | 10 | Month | 27 | Day |
Last modified on
| 2023 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060064
