UMIN-CTR Clinical Trial

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
Email	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
Email	tahara.ayako.157@m.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	Kyushu University Hospital
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel	092-642-5774
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040757