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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034803
Receipt No. R000039671
Official scientific title of the study The effectiveness of the preoperative operation-room tour helps children's anxiety less and the induction of anesthesia easy.
Date of disclosure of the study information 2018/11/07
Last modified on 2018/11/07

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Basic information
Official scientific title of the study The effectiveness of the preoperative operation-room tour helps children's anxiety less and the induction of anesthesia easy.
Title of the study (Brief title) The effectiveness of the preoperative operation-room tour.
Region
Japan

Condition
Condition the preoperative anxiety of children
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effectiveness of our preoperative operation-room tour helps children's anxiety less and the induction of anesthesia easy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Each anesthesia assesses the degree of difficulty of the induction of anesthesia with a 4-point of scale.(1:not at all, 2:slightly difficult, 3:very difficult, 4:start over)
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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Child-Life-Specialist or Child-Care-Stuff provides an operation-room tour before elective surgery for children and let them experience from the entrance of the operation-room till the putting on a mask.
Interventions/Control_2 Child-Life-Specialist or Child-Care-Stuff provides a standard care for children which is a preparation using pictures and dolls.
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
5 years-old <=
Age-upper limit
10 years-old >=
Gender Male and Female
Key inclusion criteria elective surgery
Key exclusion criteria having a documented behavioral or psychiatric disorders, having experiences of surgery under 1 year old, the use of intrarectal administration of midazolam, emergency surgery, patients who are decided inappropriate to the study
Target sample size 400

Research contact person
Name of lead principal investigator Tetsuya Kawabata
Organization Okinawa Prefectural Nanbu Medical Center & Children's Medical Center
Division name anesthesiology
Address 118-1 Aza Arakawa, Haebaru-cho, Shimajiri-gun, Okinawa Prefecture
TEL 0988880123
Email higekawa@yahoo.co.jp

Public contact
Name of contact person Shiho Tobaru
Organization Okinawa Prefectural Nanbu Medical Center & Children's Medical Center
Division name anesthesiology
Address 118-1 Aza Arakawa, Haebaru-cho, Shimajiri-gun, Okinawa Prefecture
TEL 0988880123
Homepage URL
Email mizuki.rin68@gmail.com

Sponsor
Institute Okinawa Prefectural Nanbu Medical Center & Children's Medical Center
Institute
Department

Funding Source
Organization Okinawa Prefectural Nanbu Medical Center & Children's Medical Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 11 Month 07 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 31 Day
Anticipated trial start date
2017 Year 10 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 07 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039671

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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