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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035594
Receipt No. 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 2019/07/21

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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
Email 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
Email yamashy2@cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

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
Email chisatos@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
2019 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040557

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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