UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047197 |
|---|---|
| Receipt number | R000053826 |
| Scientific Title | Reliability and Validity of a Japanese language questionnaire for screening for Tension-type headache. |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2022/09/15 18:27:42 |
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Basic information
Public title
Reliability and Validity of a Japanese language questionnaire for screening for Tension-type headache.
Acronym
Reliability and Validity of a Japanese language questionnaire for screening for Tension-type headache.
Scientific Title
Reliability and Validity of a Japanese language questionnaire for screening for Tension-type headache.
Scientific Title:Acronym
Reliability and Validity of a Japanese language questionnaire for screening for Tension-type headache.
Region
| Japan |
Condition
Condition
Tension-type headache
Classification by specialty
| Neurology | Psychosomatic Internal Medicine | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim of the study is to develop a self-administered headache questionnaire in Japanese for the screening of tension-type headache (TTH).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Screener to identify tension-type headache
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In this study, the respondents were 18 years old or older who responded to the survey after understanding the content of the survey. The two groups are "those who have been diagnosed with tension-type headache" and "those who have not been diagnosed with tension-type headache.
Key exclusion criteria
Those who interrupted their responses to the survey, and those who are under 18 years of age.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Tayama |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama, 359-1192 JAPAN
TEL
04-2947-6848
jtayama@waseda.jp
Public contact
Name of contact person
| 1st name | Kaho |
| Middle name | |
| Last name | Tanobe |
Organization
Waseda University
Division name
Graduate School of Human Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama, 359-1192 JAPAN
TEL
04-2947-6848
Homepage URL
kaho199566317@ruri.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Review Committee on Research with Human Subjects of Waseda University
Address
1-104 Totsukacho, Shinjuku-ku, Tokyo, 169-8050, JAPAN
Tel
03-5272-1639
rinri@list.waseda.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
| 2022 | Year | 03 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, a tension-type headache screener will be developed based on the diagnostic criteria for headache established by the Headache Classification Committee of the International Headache Society (ICHD-3) and examined for reliability and validity. Surveys will be administered to headache patients and data will be obtained. No personal information will be obtained in this study.
Management information
Registered date
| 2022 | Year | 03 | Month | 17 | Day |
Last modified on
| 2022 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053826
