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

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 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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name