UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035034 |
|---|---|
| Receipt number | R000039940 |
| Scientific Title | Development of the new monitor system to predict stress response by measuring the emotional sweating |
| Date of disclosure of the study information | 2018/11/28 |
| Last modified on | 2019/11/28 17:08:22 |
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Basic information
Public title
Development of the new monitor system to predict stress response by measuring the emotional sweating
Acronym
Development of the new monitor system to predict stress response by measuring the emotional sweating
Scientific Title
Development of the new monitor system to predict stress response by measuring the emotional sweating
Scientific Title:Acronym
Development of the new monitor system to predict stress response by measuring the emotional sweating
Region
| Japan |
Condition
Condition
dental phobia
severe gag reflex
Classification by specialty
| Anesthesiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is the development of the monitor system to predict the disturbance of anterograde amnesic effect and body movement as stress response by the measuring emotional sweating rate during intravenous sedation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the influence of the increase of the emotional sweating rate, body movement, increased values of BIS level and predicted effect-site concentration of sedative agents on the amnesic effect during dental treatment under intravenous sedation
Key secondary outcomes
the relation with emotional sweating rate and dental procedure contents in case of the volunteer
the relation with the emotional sweating rate and dental procedure contents in case of the patients with normal dental treatment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients with dental phobia or gag reflex who need dental treatment under intravenous sedation
volunteer(adult, over 20 years old)
patients with normal dental treatment
Key exclusion criteria
When we can not obtain the consent to study of patients and their family
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Saori |
| Middle name | |
| Last name | Takagi |
Organization
Meikai University School of Dentistry
Division name
Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences
Zip code
350-0283
Address
1-1 Keyakidai, Sakado-shi, Saitama, Japan
TEL
049-279-2738
sogami@dent.meikai.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Takagi |
Organization
Meikai University School of Dentistry
Division name
Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences
Zip code
350-0283
Address
1-1 Keyakidai, Sakado-shi, Saitama, Japan
TEL
049-279-2738
Homepage URL
sogami@dent.meikai.ac.jp
Sponsor or person
Institute
Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Meikai University School of Dentistry
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
Meikai University School of Dentistry
Address
1-1 Keyakidai, Sakado-shi, Saitama, Japan
Tel
049-279-2738
sogami@dent.meikai.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
| 2018 | Year | 11 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
increase of the emotional sweating rate, body movement, increased values of BIS level, predicted effect-site concentration of sedative agents and the amnesic effect during dental treatment under intravenous sedation
Management information
Registered date
| 2018 | Year | 11 | Month | 27 | Day |
Last modified on
| 2019 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039940
