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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035780
Receipt No. R000040757
Scientific Title Investigation on environmental factors of patient stress during regular dental checkup
Date of disclosure of the study information 2020/03/01
Last modified on 2019/02/05

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Basic information
Public title Investigation on environmental factors of patient stress during regular dental checkup
Acronym Environmental Factors of Patient Stress at Regular Dental Checkup
Scientific Title Investigation on environmental factors of patient stress during regular dental checkup
Scientific Title:Acronym Environmental Factors of Patient Stress at Regular Dental Checkup
Region
Japan

Condition
Condition Regular dental checkup
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 the characteristics of the clinic to the patients' stress at the routine dental checkups.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes POMS2
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Great clinic room No window
Interventions/Control_2 Great clinic room with window
Interventions/Control_3 No single room window
Interventions/Control_4 Single room with window
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 Patients who came to the hospital regularly after dental treatment
Patient who fully understand the research plan and can consent by himself / herself
Patients who are over 20 years of age at consent acquisition
Key exclusion criteria Patient in dental treatment
Patients who are judged that researchers are not appropriate as research subjects
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KIYOSHI KOYANO
Organization Kyushu University Hospital
Division name Section of Implant and Rehabilitative Dentistry Division of Oral Rehabilitation, Faculty of Dental Science, Kyushu University
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-6441
Email koyano@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name AYAKO TAHARA
Organization Kyushu University Hospital
Division name Department of Medical Technology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-6440
Homepage URL
Email mouri@med.kyushu-u.ac.jp

Sponsor
Institute Section of Implant and Rehabilitative Dentistry Division of Oral Rehabilitation, Faculty of Dental Science, Kyushu University
Institute
Department

Funding Source
Organization Nothing
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
Address
Tel
Email

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
2020 Year 03 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
2018 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2020 Year 03 Month 01 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
2019 Year 02 Month 05 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040757

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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