UMIN-CTR Clinical Trial

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
Email	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
Email	kaho199566317@ruri.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053826