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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000021075
Receipt No. R000024310
Scientific Title Difficulty in a life and concern of needs of a child and the family with pediatric surgery diseases about female genitals
Date of disclosure of the study information 2017/12/12
Last modified on 2018/08/22

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Basic information
Public title Difficulty in a life and concern of needs of a child and the family with pediatric surgery diseases about female genitals
Acronym Difficulty in a life and concern of needs of a child and the family with pediatric surgery diseases about female genitals
Scientific Title Difficulty in a life and concern of needs of a child and the family with pediatric surgery diseases about female genitals
Scientific Title:Acronym Difficulty in a life and concern of needs of a child and the family with pediatric surgery diseases about female genitals
Region
Japan

Condition
Condition anorectal malformation
cloaca
Classification by specialty
Nursing Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To describe the concerns and needs in a life of a child with diseases of female genitals and the family
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To clarify the concerns and needs in a life of a child with diseases of female genitals and the family
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 interview
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
10 years-old <
Age-upper limit
40 years-old >=
Gender Female
Key inclusion criteria On the back and the enough understanding which had the enough explanation in case of participation in this research and the subject who could get documentary consent by free will of the subjective person herself
Key exclusion criteria The patient who judged that a study person in charge was unsuitable as a subject
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miyuki Nishida
Organization Juntendo Univercity
Division name Faculuty of health Care and Nursing
Zip code
Address 2-5-1 Takasu Urayasu Chiba
TEL 047-355-3111
Email mnishida@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miyuki Nishida
Organization Juntendo University
Division name Faculty of health Care and Nursing
Zip code
Address 2-5-1 Takasu Urayasu Chiba
TEL 047-355-3111
Homepage URL
Email mnishida@juntendo.ac.jp

Sponsor
Institute Juntendo University
Faculty of health Care and Nursing
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 12 Month 12 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 Suspended
Date of protocol fixation
2016 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 22 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 08 Month 31 Day
Date analysis concluded
2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 02 Month 17 Day
Last modified on
2018 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024310

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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