UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of operating room virtual tour by virtual reality videogame on preoperative anxiety of pediatric patients: prospective, randomized, and controlled trial
Title of the study (Brief title)	The effects of virtual reality videogame on preoperative anxiety
Region	Asia(except Japan)

Condition
Condition	Preoperative anxiety
Classification by specialty	Pediatrics Psychiatry Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the effect of virtual reality (VR) videogame, by which users can experience the environment of operating room and the anesthetic procedures, on preoperative anxiety of pediatric patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	modified Yale Preoperative Anxiety Scale (mYPAS) score; baseline (before the VR game experience) and at reception area (before the operating room entrance)
Key secondary outcomes	Induction compliance checklist (ICC); during anesthetic induction Procedural Behavior rating Scale (PBRS); during anesthetic induction Parent satisfaction by numerical rating scale (NRS); The parents accompanies their children during anesthetic induction. They are asked about the whole process of anesthesia at the waiting room guided to after loss of consciousness of their children.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	At operation day, pediatric patients of intervention group were educated about the preoperative preparation and anesthetic procedures, using VR video gameby which they can experience the environment of operating room and the anesthetic procedures.
Interventions/Control_2	he patients of control group were conventionally explained about the preoperative preparation and anesthetic procedures using verbal education.
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	10 years-old >=
Gender	Male and Female
Key inclusion criteria	- American Society of Anesthesiologists (ASA) Class I and II - 4-10 yrs old - Elective surgery
Key exclusion criteria	- ASA class > II - Major surgery after which patients are transferred to intensive care unit (ICU) for postoperative care - Preterm birth - Developmental delay - Hearing or vision impairment - Affective disorder - History of epilepsy or seizure - Previous experience of general anesthesia
Target sample size	70

Research contact person
Name of lead principal investigator	Sung-Hee Han
Organization	Seoul National University Bundang Hospital
Division name	Department of Anesthesiology and Pain Medicine
Address	82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
TEL	82-31-787-7498
Email	anesthesiology@snubh.org

Public contact
Name of contact person	Jin-Woo Park
Organization	Seoul National University Bundang Hospital
Division name	Department of Anesthesiology and Pain Medicine
Address	82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
TEL	82-31-787-7499
Homepage URL
Email	jinul8282@gmail.com

Sponsor
Institute	Seoul National University Bundang Hospital
Institute
Department

Funding Source
Organization	Seoul National University Bundang Hospital
Organization
Division
Category of Funding Organization	Outside Japan
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 02 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 05 Day
Anticipated trial start date	2018 Year 02 Month 12 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 02 Month 11 Day
Last modified on	2018 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035114