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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030764
Receipt No. R000035082
Official scientific title of the study The effects of parental co-experience of operating room virtual tour by mirroring the display on the function reducing the anxiety of pediatric patients
Date of disclosure of the study information 2018/01/13
Last modified on 2018/04/16

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Basic information
Official scientific title of the study The effects of parental co-experience of operating room virtual tour by mirroring the display on the function reducing the anxiety of pediatric patients
Title of the study (Brief title) Parental co-experience of 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 As shown in our previous study, the virtual reality (VR) tour of operating room can reduce preoperative anxiety of pediatric patients. In this study, we demonstrate that parental co-experience of the VR tour can increase the effect of the tour reducing pre-operative 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 tour) and at reception area (before the operating room entrance)
Key secondary outcomes - Induction Compliance Checklist (ICC); during anesthetic induction
- Parental anxiety; baseline (before the VR tour) and during anesthetic induction
- Parental satisfaction; after anesthetic induction; Would you like to recommend the preoperative virtual reality tour to other children who are scheduled for elective surgery?

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 Active
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 are 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, in a separate empty room 1 hour before going to operation theatre.
Their parents can experience the tour by mirroring the view pediatric patients are watching in real time. They can also share sounds from the device.
Interventions/Control_2 At operation day, pediatric patients of control group are 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, in a separate empty room 1 hour before going to operation theatre.
Their parents will not share the image of VR tour.
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 80

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 01 Month 13 Day

Progress
Recruitment status Terminated
Date of protocol fixation
2018 Year 01 Month 05 Day
Anticipated trial start date
2018 Year 01 Month 15 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 01 Month 11 Day
Last modified on
2018 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035082

Research Plan
Registered date File name
2018/04/16 Study Protocol.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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