UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043138 |
|---|---|
| Receipt number | R000049250 |
| Scientific Title | Preanesthetic application of video game for anxiety reduction in disabled dental patients during anesthesia induction |
| Date of disclosure of the study information | 2021/01/28 |
| Last modified on | 2021/01/26 19:33:15 |
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Basic information
Public title
Preanesthetic application of video game for
anxiety reduction in disabled patients during
anesthesia induction
Acronym
Anesthetic induction with video game
Scientific Title
Preanesthetic application of video game for
anxiety reduction in disabled dental patients
during anesthesia induction
Scientific Title:Acronym
Anesthetic induction with video game
Region
| Japan |
Condition
Condition
Patients with physically, mentally and developmental disorder, and mental retardation
Classification by specialty
| Psychiatry | Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to test a hypothesis that, in disabled patients, preanesthetic application of video game could reduce anxiety during anesthesia induction and postoperative regressive behavior which has been confirmed in healthy pediatric patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Induction Compliance Check-list (ICC)
Key secondary outcomes
Preoperative Anxiety: Modified Yale Preoperative Anxiety Scale (mYPAS)
Parent Anxiety: State-Trait Anxiety Inventory
(STAI)
Emergence Delirium: WATCHA scale
The Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Without preanesthetic application of video game
Interventions/Control_2
Preanesthetic application of video game
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
| 1 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Person in parental authority of the disabled
patient agrees the purpose of this research and participate voluntarily.
2. Patient with ASA-PS 1/2
3. Gender does not matter
Key exclusion criteria
1.Patients refuse the use of video game or
equipment.
2.Person in parental authority of the disabled
patient refuse induction with video game.
3.Developmental age of person in parental
authority is 12 years old or less, since
State-Trait Anxiety Inventory (STAI) is suitable
for ages over 12years old.
4.Severe visual impairment, disable or
undesirable to manipulate the equipment due to physical or mental problems.
5.Patients who permit or ask to secure venous
route under consciousness.
6.Patients whom the lead principal investigator
judges as inappropriate.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | katsuhisa |
| Middle name | |
| Last name | sunada |
Organization
The Nippon Dental University School of Life
Dentistry
Division name
Dental Anesthesiology
Zip code
102-8157
Address
1-9-20 Fujimi Chiyoda Tokyo
TEL
81-3-3261-6064
katsu.sunada@nifty.com
Public contact
Name of contact person
| 1st name | katsuhisa |
| Middle name | |
| Last name | sunada |
Organization
The Nippon Dental University School of Life Dentistry at Tokyo
Division name
Dental Anesthesiology
Zip code
102-8157
Address
1-9-20 Fujimi Chiyoda Tokyo
TEL
81-3-3261-6064
Homepage URL
katsu.sunada@nifty.com
Sponsor or person
Institute
The Nippon Dental University School of Life
Dentistry
Institute
Department
Personal name
Funding Source
Organization
The Nippon Dental University School of Life
Dentistry
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of NDU
Address
1-9-20 Fujimi Chiyoda Tokyo
Tel
81-3-3261-8311
ndu-rinri@tky.ndu.ac.jp
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 | 28 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 26 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049250
