UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049043