UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008607 |
|---|---|
| Receipt number | R000010118 |
| Scientific Title | Effectiveness of yoga on healthy pregnant women in Japan : quasi-experimental study. |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2015/08/03 13:53:17 |
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Basic information
Public title
Effectiveness of yoga on healthy pregnant women in Japan : quasi-experimental study.
Acronym
Effectiveness of yoga on healthy pregnant women.
Scientific Title
Effectiveness of yoga on healthy pregnant women in Japan : quasi-experimental study.
Scientific Title:Acronym
Effectiveness of yoga on healthy pregnant women.
Region
| Japan |
Condition
Condition
Healthy pregnant women
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of integrated yoga on pregnancy and birth outcomes and the quality of life in healtyh pregnant women.
Basic objectives2
Others
Basic objectives -Others
Immediate stress reduction effect of yoga during pregnancy: One group pre-posttest using salivary cortisol and alpha-amylase
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mental health
Key secondary outcomes
oxidative stress
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Yoga program
Interventions/Control_2
Usual care
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Healthy singleton pregnant women without pregnant complications.
Key exclusion criteria
Pregnant women are illiterate in Japanese.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayo Matsuzaki |
Organization
The University of Tokyo
Division name
Division of Health Sciences & Nursing, Graduate school of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL
03-5841-3396
msumi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayo Matsuzaki |
Organization
The University of Tokyo
Division name
Division of Health Sciences & Nursing, Graduate school of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL
03-5841-3396
Homepage URL
msumi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | 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
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
| 2012 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 03 | Day |
Last modified on
| 2015 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010118
| Research Plan | |
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| 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 |
