UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Operating Room Virtual Tour on Preoperative Anxiety of Pediatric Patients: A Prospective, Randomized, and Controlled Trial
Acronym	Operating Room Virtual Tour
Scientific Title	The Effect of Operating Room Virtual Tour on Preoperative Anxiety of Pediatric Patients: A Prospective, Randomized, and Controlled Trial
Scientific Title:Acronym	Operating Room Virtual Tour
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 operating room virtual tour, showing the environment of operating room and the anesthetic procedures, on preoperative anxiety of pediatric patients who undergo operation under general anesthesia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	modified Yale preoperative anxiety scale (mYPAS score); 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 and their parents were educated using virtual tour program showing the environment of operating room and the anesthetic procedures. A 360 degree and virtual reality (VR) video for the tour program was filmed in advance and is provided using a head mount device into which a smartphone is installed, at 30 minute before the induction of anesthesia.
Interventions/Control_2	The patients and parents of control group were conventionally explained about 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	35

Research contact person
Name of lead principal investigator	1st name Sung-Hee Middle name Last name Han
Organization	Seoul National University Bundang Hospital
Division name	Department of Anesthesiology and Pain Medicine
Zip code	13620
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	1st name Jin-Woo Middle name Last name Park
Organization	Seoul National University Bundang Hospital
Division name	Department of Anesthesiology and Pain Medicine
Zip code	13620
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	Republic of Korea

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

IRB Contact (For public release)
Organization	Seoul National University Bundang Hospital
Address	82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
Tel	82-31-787-8801
Email	snubhirb@gmail.com

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 12 Month 12 Day

Related information
URL releasing protocol
Publication of results	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	2016 Year 10 Month 10 Day
Date of IRB	2016 Year 10 Month 20 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2017 Year 04 Month 12 Day
Date of closure to data entry	2017 Year 04 Month 12 Day
Date trial data considered complete	2017 Year 04 Month 15 Day
Date analysis concluded	2017 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 12 Month 12 Day
Last modified on	2022 Year 03 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029009