UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050834 |
|---|---|
| Receipt number | R000057932 |
| Scientific Title | The applicaiton of VR digital twin to preoperative experiential education for pediatric patients |
| Date of disclosure of the study information | 2023/04/13 |
| Last modified on | 2025/01/26 17:07:34 |
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Basic information
Public title
The applicaiton of VR digital twin to preoperative experiential education for pediatric patients
Acronym
VR digital twin education
Scientific Title
The applicaiton of VR digital twin to preoperative experiential education for pediatric patients
Scientific Title:Acronym
VR digital twineducation
Region
| Asia(except Japan) |
Condition
Condition
Preoperative anxiety of pediatric patients
Classification by specialty
| Pediatrics | Psychiatry | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of VR digital twin education and tablet video education on preoperative anxiety in pediatric patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Preoperative anxiety measured with modified Yale Preoperative Anxiety Scale (mYPAS)
Key secondary outcomes
- Induction Compliance Checklist (ICC) during anesthetic induction
- Procedural Behavior rating Scale (PBRS) during anesthetic induction
- Induction time
- Parental satisfaction assessed with numerical rating scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Before entering the operation room, pediatric patients of VR digital twin group were educated about the preoperative preparation and anesthetic procedures, using VR digital twin education system including 3D 360 degree head mounted display.
Interventions/Control_2
Before entering the operation room, pediatric patients of tablet group were educated about the preoperative preparation and anesthetic procedures, using tablet PC application presenting the same content as that of VR digital twin system.
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
| 8 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- ASA I or II
- 4-8 yrs old
Key exclusion criteria
- ASA III or IV
- Preterm birth or chronic disease
- Developmental delay
- Hearing or visual impairment
- Affective Disorder
- History of epilepsy
- Previous experience of blood examination within the last year
Target sample size
102
Research contact person
Name of lead principal investigator
| 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
jinul8282@gmail.com
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
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
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
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
| 2023 | Year | 04 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 13 | Day |
Last modified on
| 2025 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057932
