UMIN-CTR Clinical Trial

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
Email	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
Email	sogami@dent.meikai.ac.jp

Sponsor
Institute	Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences, Meikai University School of Dentistry
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039940