UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052556 |
|---|---|
| Receipt number | R000058591 |
| Scientific Title | Examining the effect of picture book reading by seniors on mothers' sense of trust in the community |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/10/20 09:43:22 |
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Basic information
Public title
Examining the effect of picture book reading by seniors on mothers' sense of trust in the community
Acronym
Association between picture book reading and community trust
Scientific Title
Examining the effect of picture book reading by seniors on mothers' sense of trust in the community
Scientific Title:Acronym
Association between picture book reading and community trust
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of picture book reading by senior volunteers on postpartum mothers' sense of trust in the community, loneliness, and anxiety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Social capital of mothers
Key secondary outcomes
Mothers' perceptions of picture book reading, trust in community, social support status, attributes, psychological measures. Senior volunteers' and midwives' impressions and improvements, senior volunteers' trust in the community, frequency of storytelling, attributes, and psychological measures.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Senior volunteers provide picture book reading for mothers who participate in the postpartum care program.
Interventions/Control_2
No picture book reading by senior volunteers to mothers in the postpartum care program.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Mothers participating in the postpartum care program, senior volunteers who provide picture book readings, and midwives who manage the postpartum care program, and those who have given their consent to participate in this study.
Key exclusion criteria
Those who cannot give consent to participate in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Social Participation and Healthy Aging
Zip code
173-0004
Address
3-9-7 Itabashi,Itabashi-ku,Tokyo
TEL
03-6905-6781
fujihira@tmig.or.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Fujihira |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Social Participation and Healthy Aging
Zip code
173-0004
Address
3-9-7 Itabashi,Itabashi-ku,Tokyo
TEL
03-6905-6781
Homepage URL
fujihira@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Suicide Countermeasures Promotion Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-3241
mami_yoshioka@tmghig.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 | 12 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2024 | 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 | 20 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058591
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
