UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021075 |
|---|---|
| Receipt number | 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 17:10:40 |
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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
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
mnishida@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Faculty of health Care and Nursing
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024310
