UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035594 |
|---|---|
| Receipt number | R000040557 |
| Scientific Title | Use of virtual reality to relieve anxiety during impacted mandibular third molar extraction under local anesthesia |
| Date of disclosure of the study information | 2019/01/19 |
| Last modified on | 2020/08/03 11:08:25 |
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Basic information
Public title
Use of virtual reality to relieve anxiety during impacted mandibular third molar extraction under local anesthesia
Acronym
Use of virtual reality to relieve anxiety during impacted mandibular third molar extraction
Scientific Title
Use of virtual reality to relieve anxiety during impacted mandibular third molar extraction under local anesthesia
Scientific Title:Acronym
Use of virtual reality to relieve anxiety during impacted mandibular third molar extraction
Region
| Japan |
Condition
Condition
impacted mandibular third molar
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effective use of VR in medicine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a questionnaire that included a visual analog scale (VAS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
During tooth extraction (with VR)
Interventions/Control_2
During tooth extraction (without VR)
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The person who extracts impacted mandibular third molar
Key exclusion criteria
1)Pregnabcy
2)History of epilepsy
3)Heart disease
4)Dementia, mental retardation, mental illness
5)Claustrophobia
6)Currently undergoing treatment for dental phobia
7)Treatment requiring moe than 1 h
Target sample size
67
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Yamashita |
Organization
Saga university
Division name
Faculty of Medicine, Department of Oral and Maxillofacil Surgery
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga city, Japan
TEL
0952-34-2397
yamashy2@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Yamashita |
Organization
Saga university
Division name
Faculty of Medicine, Department of Oral and Maxillofacil Surgery
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga city, Japan
TEL
0952-34-2397
Homepage URL
yamashy2@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga University
Address
5-1-1 Nabeshima, Saga City, 849-8501, Japan
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.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
佐賀大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 19 | Day |
Last modified on
| 2020 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040557
