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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015442
Receipt No. R000017955
Scientific Title To assess the effects of i-Pad in assisting induction of anesthesia in children
Date of disclosure of the study information 2014/11/01
Last modified on 2018/05/04

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Basic information
Public title To assess the effects of i-Pad in assisting induction of anesthesia in children
Acronym To assess the effects of i-Pad in assisting induction of anesthesia in children
Scientific Title To assess the effects of i-Pad in assisting induction of anesthesia in children
Scientific Title:Acronym To assess the effects of i-Pad in assisting induction of anesthesia in children
Region
Japan

Condition
Condition children anesthetized for the elective surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects of i-Pad in assisting induction of anesthesia in children by reducing their anxiety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes modified Yale Preoperative Anxiety Scale (mYPAS) at the time of induction of anesthesia
Key secondary outcomes modified Yale Preoperative Anxiety Scale (mYPAS) on the following day after surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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
Maneuver
Interventions/Control_1 distraction with i-Pad video clips
Interventions/Control_2 without distraction with i-Pad video clips
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
6 months-old <=
Age-upper limit
72 months-old >=
Gender Male and Female
Key inclusion criteria ASA 1 or 2 children anesthetized for the elective surgery
Key exclusion criteria ASA 3 or 4 or5
emergency operation
having operative experience
having anesthesia experience
Target sample size 90

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Noriyuki Echigo
Organization Yokohama Rosai Hospital
Division name Department of anesthesiology
Zip code
Address 3211 Kozukue-cho, Kouhoku-ku, Yokohama, Kanagawa 222-0036, Japan
TEL 045-474-8111
Email echigo0408@ybb.ne.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Taikan Nanao
Organization Yokohama Rosai Hospital
Division name Department of anesthesiology
Zip code
Address 3211 Kozukue-cho, Kouhoku-ku, Yokohama, Kanagawa 222-0036, Japan
TEL 045-474-8111
Homepage URL
Email shomuka@yokohamah.rofuku.go.jp

Sponsor
Institute Yokohama Rosai Hospital
Institute
Department

Funding Source
Organization Yokohama Rosai Hospital
Department of anesthesiology
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
2014 Year 11 Month 01 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
2014 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 20 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
2014 Year 10 Month 16 Day
Last modified on
2018 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017955

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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