UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045187 |
|---|---|
| Receipt number | R000050970 |
| Scientific Title | Educational effect of online simulation on medical emergencies during dental treatment |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2025/02/19 16:16:28 |
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Basic information
Public title
Online education and its effects on sudden changes in patients during dental treatment
Acronym
Online education and its effects on sudden changes in patients during dental treatment
Scientific Title
Educational effect of online simulation on medical emergencies during dental treatment
Scientific Title:Acronym
Educational effect of online simulation on medical emergencies during dental treatment
Region
| Japan |
Condition
Condition
Medical emergencies during dental treatment
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate whether there is an educational effect equivalent to face-to-face when conducting medical emergencies simulation training for dental provider via online.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prepare a mannequin on a dental chair and present a scenario of developing anaphylaxis during dental treatment.The subject's diagnostic and therapeutic skills are assessed by a checklist, with the score being the primary outcome.
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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Approximately one month before the study is conducted, a textbook on medical emergencies during dental treatment will be provided to the study subjects. In addition, give the URL for viewing the video that explains the contents of the text, and instruct the preview using them. On the day of the study, a written test will be conducted to evaluate whether the subject's knowledge level has reached a certain standard (correct answer rate of 60% or more). The study subjects are divided into three groups: (1) control group (20 people), (2) face-to-face instruction group (20 people), and (3) online instruction group (20 people). (1) The subjects in the control group will be evaluated by a checklist for their diagnostic and therapeutic skills based on the anaphylaxis scenario during dental treatment (practical test). After the evaluation is completed, a questionnaire survey will be conducted on all subjects to evaluate their understanding, confidence and motivation regarding medical emergencies.
Interventions/Control_2
(2) The subjects of the face-to-face guidance group will participate in a simulation training on the diagnosis and treatment of anaphylaxis for about 30 minutes, and receive face-to-face guidance from a dental anesthesiologist. After that, the skill is evaluated in the same way as the control group.
Interventions/Control_3
(3) The subjects of the online guidance group will participate in a simulation training on the diagnosis and treatment of anaphylaxis for about 30 minutes, and receive guidance online from a dental anesthesiologist via Zoom. The content of instruction is the same as face-to-face instruction group. After that, the skill is evaluated in the same way as the control group.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Dentists, dental hygienists, and dental students working at Niigata University Medical and Dental Hospital.
Key exclusion criteria
Those who have a correct answer rate of less than 60% in the written test before conducting the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naotaka |
| Middle name | |
| Last name | Kishimoto |
Organization
Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University
Division name
Division of Dental Anesthesiology
Zip code
9518514
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan
TEL
025-227-2972
kishimoto@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Naotaka |
| Middle name | |
| Last name | Kishimoto |
Organization
Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University
Division name
Division of Dental Anesthesiology
Zip code
951-8514
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan
TEL
025-227-2972
Homepage URL
kishimoto@dent.niigata-u.ac.jp
Sponsor or person
Institute
Division of Dental Anesthesiology, Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata University
Institute
Department
Personal name
Funding Source
Organization
Division of Dental Anesthesiology, Faculty of Dentistry & Graduate School of Medical and Dental Sciences, Niigata 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
Ethical Review Board, Niigata University
Address
757 Ichibancho, Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
Tel
025-227-2625
ethics@adm.niigata-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 20 | 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
| Delay expected |
Results Delay Reason
The number of study participants is less than expected
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
| 2021 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050970
