UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023555
Receipt No. R000026543
Scientific Title Comparative study of Video Glass and Portable DVD Player on the reduction of preoperative anxiety in children
Date of disclosure of the study information 2016/08/09
Last modified on 2016/08/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparative study of Video Glass and Portable DVD Player on the reduction of preoperative anxiety in children
Acronym Comparative study of Video Glass and Portable DVD Player on the reduction of preoperative anxiety in children
Scientific Title Comparative study of Video Glass and Portable DVD Player on the reduction of preoperative anxiety in children
Scientific Title:Acronym Comparative study of Video Glass and Portable DVD Player on the reduction of preoperative anxiety in children
Region
Japan

Condition
Condition Children who receive general anesthesia
Classification by specialty
Anesthesiology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of video glass and portable DVD player for reducing preoperative anxiety in children.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The modified Yale Preoperative Anxiety Scale: mYPAS
Key secondary outcomes

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 General anesthetic induction is performed with video glass in children.
Interventions/Control_2 General anesthetic induction is performed with portable DVD player in chileren.
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
4 years-old <=
Age-upper limit
7 years-old >=
Gender Male and Female
Key inclusion criteria Children who undergo operation procedure under general anesthesia.
ASA-PS 1 or 2.
Key exclusion criteria Children who have severe mental and physical disoder, visual and auditorial disturbance.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hashimoto Yuki
Organization Tomakomai city hospital
Division name Anesthesiology
Zip code
Address 1-5-20 Shimizu-cho, Tomakomai, Hokkaido
TEL 0144-33-3131
Email yuuki.yuuki423@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hashimoto Yuki
Organization Tomakomai city hospital
Division name Anesthesiology
Zip code
Address 1-5-20 Shimizu-cho, Tomakomai, Hokkaido
TEL 0144-33-3131
Homepage URL
Email yuuki.yuuki423@gmail.com

Sponsor
Institute Tomakomai city hospital
Institute
Department

Funding Source
Organization nothing
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
2016 Year 08 Month 09 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
2016 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 09 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
2016 Year 08 Month 09 Day
Last modified on
2016 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026543

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.