UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031252 |
|---|---|
| Receipt number | R000035114 |
| Scientific Title | The effect of operating room virtual tour by virtual reality videogame on preoperative anxiety of pediatric patients: prospective, randomized, and controlled trial |
| Date of disclosure of the study information | 2018/02/11 |
| Last modified on | 2018/10/09 15:05:59 |
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Basic information
Public title
The effect of operating room virtual tour by virtual reality videogame on preoperative anxiety of pediatric patients: prospective, randomized, and controlled trial
Acronym
The effects of virtual reality videogame on preoperative anxiety
Scientific Title
The effect of operating room virtual tour by virtual reality videogame on preoperative anxiety of pediatric patients: prospective, randomized, and controlled trial
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Sung-Hee Han |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
TEL
82-31-787-7498
anesthesiology@snubh.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jin-Woo Park |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
TEL
82-31-787-7499
Homepage URL
jinul8282@gmail.com
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 05 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035114
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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