UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051468 |
|---|---|
| Receipt number | R000058709 |
| Scientific Title | The effect of general anesthesia information video (Pilot test). |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/06/28 11:14:15 |
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Basic information
Public title
The effect of general anesthesia information video (Pilot test).
Acronym
The effect of general anesthesia information video (Pilot test).
Scientific Title
The effect of general anesthesia information video (Pilot test).
Scientific Title:Acronym
The effect of general anesthesia information video (Pilot test).
Region
| Japan |
Condition
Condition
Parents of special needs patients who are treated by general anesthesia at dentistry.
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of general anesthesia information method for parents who have children at special needs dentistry.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
State-Trait Anxiety Inventory (STAI)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Oral explanation is selected as a general anesthesia information.
Interventions/Control_2
Video explanation is selected as a general anesthesia information.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Health volunteers
Key exclusion criteria
ASA PS-2~6
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Sunada |
Organization
The Nippon Dental University
Division name
Dental Anesthesiology
Zip code
102-8159
Address
1-9-20 Fujimi Chiyoda-ku Tokyo Japan
TEL
0332616083
katsu.sunada@nifty.com
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Tsutsui |
Organization
The Nippon Dental University
Division name
Dental Anesthesiology
Zip code
102-8159
Address
1-9-20 Fujimi Chiyoda-ku Tokyo Japan
TEL
03-3261-6083
Homepage URL
tsutsuiy@tky.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University
Institute
Department
Personal name
Funding Source
Organization
The Nippon Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Nippon Dental University
Address
1-9-20 Fujimi Chiyoda-ku Tokyo Japan
Tel
03-3261-6083
tsutsuiy@tky.ndu.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 01 | 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
| 2023 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | 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
| 2023 | Year | 06 | Month | 28 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058709
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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