UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042968 |
|---|---|
| Receipt number | R000049043 |
| Scientific Title | The effect of Virtual reality education on anxiety and pain during venopuncture procedure in pediatric patients |
| Date of disclosure of the study information | 2021/01/12 |
| Last modified on | 2022/10/25 10:52:19 |
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Basic information
Public title
The effect of Virtual reality education on anxiety and pain during venopuncture procedure in pediatric patients
Acronym
Virtual reality education of venopuncture procedure for pediatric patients
Scientific Title
The effect of Virtual reality education on anxiety and pain during venopuncture procedure in pediatric patients
Scientific Title:Acronym
Virtual reality education of venopuncture procedure for pediatric patients
Region
| Asia(except Japan) |
Condition
Condition
Anxiety and pain of pediatric patients during venopuncture procedure
Classification by specialty
| Pediatrics | Psychiatry | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the effect of Virtual reality education on anxiety and pain during venopuncture procedure in pediatric patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- The children hospital of eastern ontario pain scale (CHEOPS) for the anxiety and pain during venopuncture procedure
Key secondary outcomes
- Time needed to perform venopuncture
- Number of attempts required for successful venopuncture
- Difficulty of performing venopuncture by numerical rating scale (NRS); Health workers estimate the difficulty after the examination
- Parent satisfaction about the examination process by NRS; The parent estimate the satisfaction after the examination
- Visual analogue scale of the pain expected to occur during venipuncture; pediatric patients estimate VAS score before the intervention
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 blood 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 blood examination, pediatric patients of control group are verbally explained about the procedural process.
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
- Blood 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 blood examination within the last year
Target sample size
60
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
anesthesia@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
| 2021 | Year | 01 | Month | 12 | 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
60
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
| 2019 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 09 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049043
| 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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