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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027669
Receipt No. R000031693
Scientific Title Invention of a respiration-linked tablet game system for supporting pediatric anesthesia induction
Date of disclosure of the study information 2017/06/07
Last modified on 2018/06/18

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Basic information
Public title Invention of a respiration-linked tablet game system for supporting pediatric anesthesia induction
Acronym Invention of a respiration-linked tablet game system for supporting pediatric anesthesia induction
Scientific Title Invention of a respiration-linked tablet game system for supporting pediatric anesthesia induction
Scientific Title:Acronym Invention of a respiration-linked tablet game system for supporting pediatric anesthesia induction
Region
Japan

Condition
Condition children who are supposed to receive general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To access the efficacies of the respiration-linked tablet game system in reducing children's preoperative anxiety and obtaining smoother induction of general anesthesia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effect that the respiration-linked tablet game system has on the duration to induce general anesthesia in children.
Key secondary outcomes Effect that the respiration-linked tablet game system has on children's anxiety and parent's satisfaction.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Make children to use the respiration-linked tablet game system during the inhalational induction of general anesthesia.
Interventions/Control_2 Make children to watch some cartoon movies during the inhalational induction of general anesthesia.
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
1 years-old <=
Age-upper limit
6 years-old >=
Gender Male and Female
Key inclusion criteria Child who is supposed to receive inhalational induction of general anesthesia for their elective surgery, American Society of Anesthesiology physical status 1 or 2,
Key exclusion criteria Patients with cancer, mental retardation, neuromuscular disease.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kitamura Yuji
Organization Chiba University Hospital
Division name Department of Anesthesiology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL 043-222-7171
Email yuji.kitamura@chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kitamura Yuji
Organization Chiba University Hospital
Division name Department of Anesthesiology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL 043-222-7171
Homepage URL
Email yuji.kitamura@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization N/A
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
2017 Year 06 Month 07 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 Terminated
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 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
2017 Year 06 Month 07 Day
Last modified on
2018 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031693

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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