UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021745 |
|---|---|
| Receipt number | R000025066 |
| 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 | 2016/04/04 |
| Last modified on | 2016/04/01 21:07:07 |
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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 | 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
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
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
| 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
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
nojiyasu-umin@umin.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
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
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 |
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
| 2016 | Year | 03 | Month | 24 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025066
