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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033167
Receipt No. R000037825
Scientific Title The effect of preparatory support by heart team on children undergoing cardiac surgery
Date of disclosure of the study information 2018/06/27
Last modified on 2018/06/27

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Basic information
Public title The effect of preparatory support by heart team on children undergoing cardiac surgery
Acronym Preparation support before cardiac surgery
Scientific Title The effect of preparatory support by heart team on children undergoing cardiac surgery
Scientific Title:Acronym Preparation support before cardiac surgery
Region
Japan

Condition
Condition Child undergoing cardiac surgery
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy of preparation support in children after cardiac operation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effect of preparation program
Key secondary outcomes Understanding of medical condition, Ability to deal with unusual problem, Feeling, Pain level

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Perform preparations during the perioperative period
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
7 years-old <=
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria 1) Child undergoing cardiac surgery
2) The guardian of the child who is willing to participate in a preparation program, and able to give informed consent to participation
Key exclusion criteria A child who is prohibited from preparation program by doctors
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Muneaki Matsubara
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Cardiovascular Surgery
Zip code
Address 1-1-1, Tennodai, Tsukuba, Ibaraki
TEL 029-853-3210
Email matsubaram@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Muneaki Matsubara
Organization University of Tsukuba
Division name Department of Cardiovascular Surgery
Zip code
Address 1-1-1, Tennodai, Tsukuba, Ibaraki
TEL 029-853-3210
Homepage URL
Email matsubaram@md.tsukuba.ac.jp

Sponsor
Institute Department of Cardiovascular Surgery, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization Department of Cardiovascular Surgery, Faculty of Medicine, University of Tsukuba
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 06 Month 27 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
2018 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 07 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
2018 Year 06 Month 27 Day
Last modified on
2018 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037825

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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