UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042619 |
|---|---|
| Receipt number | R000048637 |
| Scientific Title | Effects of parent-child dance on mother's child-rearing stress and mother-child center of gravity sway |
| Date of disclosure of the study information | 2020/12/02 |
| Last modified on | 2021/02/26 12:29:30 |
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Basic information
Public title
Effects of parent-child dance on mother's child-rearing stress and mother-child center of gravity sway
Acronym
Effects of parent-child dance on mother's child-rearing stress and mother-child center of gravity sway
Scientific Title
Effects of parent-child dance on mother's child-rearing stress and mother-child center of gravity sway
Scientific Title:Acronym
Effects of parent-child dance on mother's child-rearing stress and mother-child center of gravity sway
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 the effect of dancing together with the mother and child on the child-rearing stress of the mother and the sway of the center of gravity of the mother and child.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PSI-SF scores, percentiles
Key secondary outcomes
Changes in age, height, weight, and before and after the intervention in the questionnaire. Total locus length and outer peripheral area of center of gravity sway measurement.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Dance-(wash-out period)- Light exercise.
Dance or light exercise is performed once a week for about2 0 minutes, for a total of 4 times.
Interventions/Control_2
Light exercise-(wash-out period)-dance.
Dance or light exercise is performed once a week for about 20 minutes, for a total of 4 times.
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
| 2 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Female
Key inclusion criteria
31-35 years old, part-timer, healthy mother of nuclear family and their child. The standard is that the child is 2.3 years old, a girl, and has no siblings.
Key exclusion criteria
The mother is pregnant. Persons who have difficulty in exercising, such as injuries or illnesses.
Target sample size
60
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
z19j024h@mail.cc.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2020 | Year | 12 | Month | 02 | 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
22
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
| 2020 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 02 | Day |
Last modified on
| 2021 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048637
| 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 |
