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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035485
Receipt No. R000040432
Scientific Title The experiential education platform for pediatric patients undergoing chest radiographic examination: a comparison between 360 degree virtual reality and tablet video
Date of disclosure of the study information 2019/01/08
Last modified on 2019/01/08

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Basic information
Public title The experiential education platform for pediatric patients undergoing chest radiographic examination: a comparison between 360 degree virtual reality and tablet video
Acronym The experiential education of radiographic examination for pediatric patients: virtual reality vs tablet video
Scientific Title The experiential education platform for pediatric patients undergoing chest radiographic examination: a comparison between 360 degree virtual reality and tablet video
Scientific Title:Acronym The experiential education of radiographic examination for pediatric patients: virtual reality vs tablet video
Region
Asia(except Japan)

Condition
Condition Distress and anxiety of pediatric patients during radiographic examination
Classification by specialty
Pediatrics Psychiatry Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of experiential education between virtual reality and tablet video on distress and anxiety of pediatric patients undergoing chest radiographic examination.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes - Observational Scale of Behavioral Distress (OSBD) during chest radiographic examination
Key secondary outcomes - The total time needed to obtain a fine radiographic film
- Number of retakes needed to obtain a fine radiographic film
- Whether the parent enters the radiology room to calm the distressed patient during the examination
- Difficulty of performing the radiographic examination by numerical rating scale (NRS); The radiologist estimate the difficulty after the examination
- Parent satisfaction about the examination process by NRS; The parent estimate the satisfaction after the examination

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 Before the chest radiographic examination, pediatric patients of intervention group are educated using virtual reality program introducing the procedural process and presenting the virtual experience of the examination.
Interventions/Control_2 Before the chest radiographic examination, pediatric patients of control group are educated using tablet video introducing the procedural process (containing the same content as the virtual reality intervention).
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 - Chest radiographic examination
- 4-8 yrs old
Key exclusion criteria - Preterm birth or chronic disease
- Developmental delay
- Hearing or visual impairment
- Affective Disorder
- History of epilepsy
- Previous experience of chest radiographic examination within the last year
Target sample size 120

Research contact person
Last 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
Email anesthesiology@snubh.org

Public contact
1st 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
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
Address
Tel
Email

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
2019 Year 01 Month 08 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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 10 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
2019 Year 01 Month 08 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040432

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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