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Recruitment status Completed
Unique ID issued by UMIN UMIN000008607
Receipt No. 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

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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
Obsterics 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email msumi-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010118


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