UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019615
Receipt number R000022667
Scientific Title Effect of Video Glass and Portable DVD Player for the Management of Preoperative Anxiety in Children.
Date of disclosure of the study information 2015/11/04
Last modified on 2018/03/28 09:43:22

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Basic information

Public title

Effect of Video Glass and Portable DVD Player for the Management of Preoperative Anxiety in Children.

Acronym

Effect of Video Glass and Portable DVD Player for the Management fo Preoperative Anxiety in Children.

Scientific Title

Effect of Video Glass and Portable DVD Player for the Management of Preoperative Anxiety in Children.

Scientific Title:Acronym

Effect of Video Glass and Portable DVD Player for the Management fo Preoperative Anxiety in Children.

Region

Japan


Condition

Condition

Anxiety during preoperative period in children

Classification by specialty

Anesthesiology Operative medicine Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this investigation is to compare the effect of video glass, new device 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 Score: mYPAS
Evaluation time: the timing of general anesthesia induction

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 children.

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

12 years-old >=

Gender

Male and Female

Key inclusion criteria

Children who undergo operation procedure under general anesthesia and whom preoperative physical status are ASA-PS 1 or 2 are included.

Key exclusion criteria

Children who have severe mental and physical disorder, visual and auditorial disturbance are excluded.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirata Naoyuki

Organization

Sapporo Medical University School of Medicine

Division name

Anesthesiology

Zip code


Address

South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Email

naohirata@mac.com


Public contact

Name of contact person

1st name
Middle name
Last name Hirata Naoyuki

Organization

Sapporo Medical University School of Medicine

Division name

Anesthesiology

Zip code


Address

South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Homepage URL


Email

naohirata@mac.com


Sponsor or person

Institute

Department of Anesthesiology, Sapporo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Sapporo Medical University School of Medicine

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

2015 Year 11 Month 04 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2015 Year 10 Month 22 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2018 Year 02 Month 16 Day

Date analysis concluded

2018 Year 02 Month 27 Day


Other

Other related information



Management information

Registered date

2015 Year 11 Month 02 Day

Last modified on

2018 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022667


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name