UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030663 |
|---|---|
| Receipt number | R000035008 |
| Scientific Title | The effects of experiential education using virtual reality on distress and anxiety of pediatric patients undergoing chest radiographic examination |
| Date of disclosure of the study information | 2018/01/03 |
| Last modified on | 2022/03/17 16:32:55 |
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Basic information
Public title
The effects of experiential education using virtual reality on distress and anxiety of pediatric patients undergoing chest radiographic examination
Acronym
Virtual reality education of radiographic examination for pediatric patients
Scientific Title
The effects of experiential education using virtual reality on distress and anxiety of pediatric patients undergoing chest radiographic examination
Scientific Title:Acronym
Virtual reality education of radiographic examination for pediatric patients
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
Evaluating the effects of education using virtual reality, which introduces procedural process and presents virtual experience, 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
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
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
The patients of control group are not educated about the chest radiographic examination.
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
Target sample size
100
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
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
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
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
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
| 2018 | Year | 01 | Month | 03 | 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
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 11 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 11 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 03 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035008
