UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030764 |
|---|---|
| Receipt number | R000035082 |
| Scientific Title | The effects of parental co-experience of operating room virtual tour by mirroring the display on the function reducing the anxiety of pediatric patients |
| Date of disclosure of the study information | 2018/01/13 |
| Last modified on | 2022/03/17 17:05:45 |
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Basic information
Public title
The effects of parental co-experience of operating room virtual tour by mirroring the display on the function reducing the anxiety of pediatric patients
Acronym
Parental co-experience of operating room virtual tour
Scientific Title
The effects of parental co-experience of operating room virtual tour by mirroring the display on the function reducing the anxiety of pediatric patients
Scientific Title:Acronym
Parental co-experience of operating room virtual tour
Region
| Asia(except Japan) |
Condition
Condition
Preoperative anxiety
Classification by specialty
| Pediatrics | Psychiatry | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As shown in our previous study, the virtual reality (VR) tour of operating room can reduce preoperative anxiety of pediatric patients. In this study, we demonstrate that parental co-experience of the VR tour can increase the effect of the tour reducing pre-operative anxiety of pediatric patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
modified Yale preoperative anxiety scale (mYPAS score); baseline (before the VR tour) and at reception area (before the operating room entrance)
Key secondary outcomes
- Induction Compliance Checklist (ICC); during anesthetic induction
- Parental anxiety; baseline (before the VR tour) and during anesthetic induction
- Parental satisfaction; after anesthetic induction; Would you like to recommend the preoperative virtual reality tour to other children who are scheduled for elective surgery?
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
At operation day, pediatric patients of intervention group are educated using virtual tour program showing the environment of operating room and the anesthetic procedures.
A 360 degree and virtual reality (VR) video for the tour program was filmed in advance and is provided using a head mount device into which a smartphone is installed, in a separate empty room 1 hour before going to operation theatre.
Their parents can experience the tour by mirroring the view pediatric patients are watching in real time. They can also share sounds from the device.
Interventions/Control_2
At operation day, pediatric patients of control group are educated using virtual tour program showing the environment of operating room and the anesthetic procedures.
A 360 degree and virtual reality (VR) video for the tour program was filmed in advance and is provided using a head mount device into which a smartphone is installed, in a separate empty room 1 hour before going to operation theatre.
Their parents will not share the image of VR tour.
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
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- American Society of Anesthesiologists (ASA) Class I and II
- 4-10 yrs old
- Elective surgery
Key exclusion criteria
- ASA class > II
- Major surgery after which patients are transferred to intensive care unit (ICU) for postoperative care
- Preterm birth
- Developmental delay
- Hearing or vision impairment
- Affective disorder
- History of epilepsy or seizure
- Previous experience of general anesthesia
Target sample size
80
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
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 | 13 | 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
| 2018 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 11 | 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=R000035082
