UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035780 |
|---|---|
| Receipt number | 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 | 2022/03/16 08:16:54 |
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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 | AYUKAWA |
| Middle name | |
| Last name | YASUNORI |
Organization
Kyushu University Hospital
Division name
Section of Implant and Rehabilitative Dentistry Division of Oral Rehabilitation, Faculty of Dental Science, Kyushu University
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6441
koyano@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | TAHARA |
| Middle name | |
| Last name | AYAKO |
Organization
Kyushu University Hospital
Division name
Department of Medical Technology
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6440
Homepage URL
tahara.ayako.157@m.kyushu-u.ac.jp
Sponsor or person
Institute
Section of Implant and Rehabilitative Dentistry Division of Oral Rehabilitation, Faculty of Dental Science, Kyushu University
Institute
Department
Personal name
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
Kyushu University Hospital
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5774
byskenkyu@jimu.kyushu-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
| 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
211
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2019 | Year | 02 | Month | 05 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040757
