UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049307
Receipt number R000056160
Scientific Title Virtual reality vs. tablet video as an experiential education platform of venipuncture procedure in pediatric patients in terms of procedural pain and anxiety
Date of disclosure of the study information 2022/10/26
Last modified on 2023/09/14 17:06:32

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Basic information

Public title

Virtual reality vs. tablet video as an experiential education platform of venipuncture procedure in pediatric patients in terms of procedural pain and anxiety

Acronym

Virtual reality vs. tablet video for pediatric patient education

Scientific Title

Virtual reality vs. tablet video as an experiential education platform of venipuncture procedure in pediatric patients in terms of procedural pain and anxiety

Scientific Title:Acronym

Virtual reality vs. tablet video for pediatric patient education

Region

Asia(except Japan)


Condition

Condition

Anxiety and pain of pediatric patients during venipuncture procedure

Classification by specialty

Pediatrics Psychiatry Laboratory medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the effect of virtual reality education and tablet video education on anxiety and pain during venipuncture 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 venipuncture procedure

Key secondary outcomes

- Time needed to perform venipuncture
- Number of attempts required for successful venipuncture
- Difficulty of performing venipuncture 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 intervention group are educated using tablet video introducing the procedural process and presenting the virtual experience of the 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

- 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

90


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

Email

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


Email

jinul8282@gmail.com


Sponsor or person

Institute

Seoul National University Bundang Hospital

Institute

Department

Personal name



Funding Source

Organization

National Research Foundation of Korea

Organization

Division

Category of Funding Organization

Government offices of other countries

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

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

2022 Year 10 Month 26 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

90

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

No longer recruiting

Date of protocol fixation

2022 Year 10 Month 25 Day

Date of IRB

2022 Year 10 Month 25 Day

Anticipated trial start date

2022 Year 10 Month 31 Day

Last follow-up date

2023 Year 04 Month 20 Day

Date of closure to data entry

2023 Year 04 Month 20 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 10 Month 25 Day

Last modified on

2023 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056160


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name