UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033167
Receipt number 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 2022/06/30 09:11:57

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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 MUNEAKI
Middle name
Last name MATSUBARA

Organization

Faculty of Medicine, University of Tsukuba

Division name

Department of Cardiovascular Surgery

Zip code

305-8575

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 MUNEAKI
Middle name
Last name MATSUBARA

Organization

University of Tsukuba

Division name

Department of Cardiovascular Surgery

Zip code

305-8575

Address

Faculty of Medicine, University of Tsukuba

TEL

029-853-3210

Homepage URL


Email

matsubaram@md.tsukuba.ac.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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

Faculty of Medicine, University of Tsukuba

Address

1-1-1 Tennodai, Tsukuba, Ibaraki

Tel

029-853-3210

Email

matsubaram@md.tsukuba.ac.jp


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

2023 Year 03 Month 31 Day

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

2022 Year 06 Month 30 Day



Link to view the page

Value
https://center6.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