UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	research on the utilization of information technology about visual strategies in a dental treatment situation with Autism
Title of the study (Brief title)	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 Dental medicine
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	face scale salivary amylase　concentration level pulse rate　during dental treatment time required for dental treatment

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	15

Research contact person
Name of lead principal investigator	Nojima Yauko
Organization	Okayama University Hospital
Division name	Special Needs Dentistry
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	Nojima Yauko
Organization	Okayama University Hospital
Division name	Special Needs Dentistry
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	岡山大学病院

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 04 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 03 Month 24 Day
Anticipated trial start date	2016 Year 04 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 01 Day
Last modified on	2016 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025066