UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030405 |
|---|---|
| Receipt number | R000034720 |
| Scientific Title | Verification of reliability and validity of Tinnitus cognitions questionnaire Japanese version |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2022/01/03 20:22:25 |
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Basic information
Public title
Verification of reliability and validity of Tinnitus cognitions questionnaire Japanese version
Acronym
Verification of reliability and validity of Tinnitus cognitions questionnaire Japanese version
Scientific Title
Verification of reliability and validity of Tinnitus cognitions questionnaire Japanese version
Scientific Title:Acronym
Verification of reliability and validity of Tinnitus cognitions questionnaire Japanese version
Region
| Japan |
Condition
Condition
Chronic tinnitus
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of reliability and validity of Tinnitus cognitions questionnaire Japanese version
Basic objectives2
Others
Basic objectives -Others
Verification of reliability and validity of Tinnitus cognitions questionnaire Japanese version
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Internal consistency: Cronbach's a calculation
Retest Reliability: Calculation of ICC (Intraclass Correlation Coefficient)
Coexistence validity: ICC calculation with external criteria
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic tinnitis patients continuing for more than 3 months
Key exclusion criteria
1)Due to physical disorders, mental illness, etc., it is difficult to answer the question paper.
2)Japanese ability to comprehend is inadequate.
3)It is judged unsuitable for participation in research.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | kayoko |
| Middle name | |
| Last name | Kabaya |
Organization
Nagoya City Univesity graduate school
Division name
School of Medicine, Ear Nose and Throat, Head and Neck Surgery
Zip code
4678601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601
TEL
052-853-8256
kabaya@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Kabaya |
Organization
Nagoya City Univesity graduate school
Division name
School of Medicine, Ear Nose and Throat, Head and Neck Surgery
Zip code
4678601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601
TEL
052-853-8256
Homepage URL
kabaya@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City Univesity graduate school
Institute
Department
Personal name
Funding Source
Organization
Self-sourcing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center Nagoya City University Hospital
Address
Kawasumi1 Mizuho-cho Mizuho-ku Nagoya, Aichi, Japan
Tel
052-851-5511
clinical_research@med.nagoya-cu.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
名古屋市立大学病院（愛知県）、春日井市民病院（愛知県）、名古屋第二赤十字病院（愛知県）、豊橋市民病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.tinnitusjournal.com/articles/relationship-between-cognition-and-the-severity-of-chronic-
Publication of results
Published
Result
URL related to results and publications
https://www.tinnitusjournal.com/articles/relationship-between-cognition-and-the-severity-of-chronic-
Number of participants that the trial has enrolled
75
Results
We obtained high Cronbach's a coefficients for the total score and subscales, ranging from 0.933 to 0.974. The total score and subscale interclass correlation coefficients for test-retest reliability ranged from 0.631 to 0.963. The factor analysis yielded a two-factor structure: negative and positive subscales. The convergent and discriminative
validity was sufficiently clear. The negative subscale of the TCQ was strongly correlated with the THI and the HADS.
Results date posted
| 2022 | Year | 01 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with chronic tinnitus persisting for longer than 3 months were
included.
Participant flow
Participants completed the TCQ, the Tinnitus Handicap Inventory (THI), and the Hospital Anxiety and Depression Scale (HADS). They also completed the TCQ a second time 3-7 days later.
Adverse events
none
Outcome measures
TCQ, THI, HADS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
non
Management information
Registered date
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2022 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034720
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/01/03 | TCQ研究 研究実施計画書20171116.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/01/03 | umin tcq.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/01/03 | umin tcq.xlsx |
