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

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 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

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

Value
https://center6.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