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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021700
Receipt No. R000025037
Scientific Title Mixed methods outcome evalute of coaching on stress-cognition in mothers with young children
Date of disclosure of the study information 2016/12/31
Last modified on 2016/03/31

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Basic information
Public title Mixed methods outcome evalute of coaching on stress-cognition in mothers with young children
Acronym Mixed methods outcome evalute of coaching
Scientific Title Mixed methods outcome evalute of coaching on stress-cognition in mothers with young children
Scientific Title:Acronym Mixed methods outcome evalute of coaching
Region
Japan

Condition
Condition health
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to evaluate mixed methods outcome of a coaching program on stress-cognition in normal healthy mothers with young children.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes stress-cognition(qualitively)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 The intervention comprise five sessions. One session is 120 minutes.
Interventions/Control_2 The intervention comprise five sessions. One session is 120 minutes.
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 Female
Key inclusion criteria Mothers of young children aged 3 months to 6 years in Japan.
Key exclusion criteria No applicable
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ohahsi Junko
Organization Kyoto Prefectural University of Medicine
Division name Graduate School of Nursing
Zip code
Address 465 Kajii-cho Kawaramachi Agaru Hirokoji Kamigyo-ku Kyoto
TEL 075-212-5440
Email johashi@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ohahsi Junko
Organization Kyoto Prefectural University of Medicine
Division name Graduate School of Nursing
Zip code
Address 465 Kajii-cho Kawaramachi Agaru Hirokoji Kamigyo-ku Kyoto
TEL 075-212-5440
Homepage URL
Email johashi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine Graduate School of Nursing
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 31 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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 31 Day
Last modified on
2016 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025037

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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