UMIN-CTR Clinical Trial

Basic information
Public title	Preanesthetic application of video game for anxiety reduction in disabled patients during anesthesia induction
Acronym	Anesthetic induction with video game
Scientific Title	Preanesthetic application of video game for anxiety reduction in disabled dental patients during anesthesia induction
Scientific Title:Acronym	Anesthetic induction with video game
Region	Japan

Condition
Condition	Patients with physically, mentally and developmental disorder, and mental retardation
Classification by specialty	Psychiatry Anesthesiology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to test a hypothesis that, in disabled patients, preanesthetic application of video game could reduce anxiety during anesthesia induction and postoperative regressive behavior which has been confirmed in healthy pediatric patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Induction Compliance Check-list (ICC)
Key secondary outcomes	Preoperative Anxiety: Modified Yale Preoperative Anxiety Scale (mYPAS) Parent Anxiety: State-Trait Anxiety Inventory (STAI) Emergence Delirium: WATCHA scale The Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Without preanesthetic application of video game
Interventions/Control_2	Preanesthetic application of video game
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	30 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Person in parental authority of the disabled patient agrees the purpose of this research and participate voluntarily. 2. Patient with ASA-PS 1/2 3. Gender does not matter
Key exclusion criteria	1.Patients refuse the use of video game or equipment. 2.Person in parental authority of the disabled patient refuse induction with video game. 3.Developmental age of person in parental authority is 12 years old or less, since State-Trait Anxiety Inventory (STAI) is suitable for ages over 12years old. 4.Severe visual impairment, disable or undesirable to manipulate the equipment due to physical or mental problems. 5.Patients who permit or ask to secure venous route under consciousness. 6.Patients whom the lead principal investigator judges as inappropriate.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name katsuhisa Middle name Last name sunada
Organization	The Nippon Dental University School of Life Dentistry
Division name	Dental Anesthesiology
Zip code	102-8157
Address	1-9-20 Fujimi Chiyoda Tokyo
TEL	81-3-3261-6064
Email	katsu.sunada@nifty.com

Public contact
Name of contact person	1st name katsuhisa Middle name Last name sunada
Organization	The Nippon Dental University School of Life Dentistry at Tokyo
Division name	Dental Anesthesiology
Zip code	102-8157
Address	1-9-20 Fujimi Chiyoda Tokyo
TEL	81-3-3261-6064
Homepage URL
Email	katsu.sunada@nifty.com

Sponsor
Institute	The Nippon Dental University School of Life Dentistry
Institute
Department

Funding Source
Organization	The Nippon Dental University School of Life Dentistry
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	IRB of NDU
Address	1-9-20 Fujimi Chiyoda Tokyo
Tel	81-3-3261-8311
Email	ndu-rinri@tky.ndu.ac.jp

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	2021 Year 01 Month 28 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	2020 Year 10 Month 26 Day
Date of IRB	2021 Year 02 Month 15 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 26 Day
Last modified on	2021 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049250