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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027681
Receipt No. R000031707
Scientific Title research on the utilization of information technology about visual strategies in a dental treatment situation with Autism
Date of disclosure of the study information 2017/06/10
Last modified on 2017/08/31

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Basic information
Public title research on the utilization of information technology about visual strategies in a dental treatment situation with Autism
Acronym research on the utilization of IT about visual strategies in a dental treatment situation with Autism
Scientific Title research on the utilization of information technology about visual strategies in a dental treatment situation with Autism
Scientific Title:Acronym research on the utilization of IT about visual strategies in a dental treatment situation with Autism
Region
Japan

Condition
Condition Autistic Spectrum Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Using an illustration and an animation, a photograph or the video of the medical treatment act, I make what can reduce the psychological uneasiness of the person receiving medical treatment clear and, using support apparatus "Hustle Denter," am intended that I evaluate the effectiveness in the clinical practice of the apparatus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes questionnaire
Key secondary outcomes salivary amylase concentration level
pulse rate during dental treatment

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 day 1: dental treatment that was supported by picture cards
day 2: dental treatment that was supported by tablets
Interventions/Control_2 day 1: dental treatment that was supported by tablets
day 2: dental treatment that was supported by picture cards
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
6 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria In patients needing dental treatment at special needs dentistry -Okayama University Hospital, autistic spectrum disorder is diagnosed to an interview vote, during a study period who performs at least two times of commuter pass medical examination, and that an agreement was provided for this study.
Key exclusion criteria Patients who performs one times of commuter pass medical examination.
Patients who have visual impairments cannot see a tablet.
Patients who can't dental examination without the support of anesthesia for non-cooperation.
Patients who adamantly refuse to visual support such as picture cards.
Patients who causes refusal without accepting you as a support equipment of the dental treatment as used tablets in a different use daily.
Patients who has difficulty in explanation with the picture cards and tablets.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nojima Yauko
Organization Okayama University Hospital
Division name Special Needs Dentistry
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City 700-8558
TEL 086-223-7151
Email nojiyasu-umin@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nojima Yauko
Organization Okayama University Hospital
Division name Special Needs Dentistry
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City 700-8558
TEL 086-223-7151
Homepage URL
Email nojiyasu-umin@umin.ac.jp

Sponsor
Institute Ministry of Education, Culture, Sports, Science and Technology
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 06 Month 10 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
2017 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 07 Day
Last modified on
2017 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031707

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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