UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045994 |
|---|---|
| Receipt number | R000052497 |
| Scientific Title | Effects of baby yoga with physical contact between mother and child on mother's mental health |
| Date of disclosure of the study information | 2021/11/05 |
| Last modified on | 2024/03/28 04:03:50 |
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Basic information
Public title
Effects of baby yoga with physical contact between mother and child on mother's mental health
Acronym
Effects of baby yoga with physical contact between mother and child on mother's mental health
Scientific Title
Effects of baby yoga with physical contact between mother and child on mother's mental health
Scientific Title:Acronym
Effects of baby yoga with physical contact between mother and child on mother's mental health
Region
| Japan |
Condition
Condition
Childcare stress
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify how the mental health of mothers changes due to the implementation of baby yoga that involves physical contact between mothers and children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PSI-SF scores, percentiles
Key secondary outcomes
State-Trait Anxiety Inventory-Form JYZ
Age, height, weight.
Changes in mind and body before and after the intervention.
Child-rearing anxiety felt by COVID-19.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Baby yoga
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
| 5 | months-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants aged 5 months to 1 year, toddlers and their mothers
Key exclusion criteria
The mother is pregnant.
Persons who have difficulty in exercising, such as injuries or illnesses.
Persons with fever of 37.5 or higher on the day.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Murayama |
Organization
Niigata University
Division name
Humanities and Sociology
Zip code
950-2181
Address
8050 Ikarashi 2, Nishi-ku, Niigata City, Niigata Prefecture
TEL
025-262-7076
murayama@ed.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Somei |
Organization
Niigata University
Division name
Graduate School of Contemporary Sociology and Culture
Zip code
950-2181
Address
8050 Ikarashi 2, Nishi-ku, Niigata City, Niigata Prefecture
TEL
08091786112
Homepage URL
z21n403k@mail.cc.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
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
Niigata University Ethics Review Committee
Address
757 Asahimachidori Ichibancho, Chuo-ku, Niigata City, Niigata Prefecture
Tel
025-227-2005
joho@med.niigata-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
| 2021 | Year | 11 | Month | 05 | 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
| 2021 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 07 | 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
| 2021 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052497
