HeadacheNCT04765501
Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Headache Impact Questionnaire
An observational study of Headache and Headache Disorders, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to investigate cultural adaptation, reliability and validity of the Turkish version of the Headache Impact Questionnaire (HIQ). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Headache, Headache Disorders, Headache, Migraine
- What is being tested?
- Survey study
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of individuals with any type of headache.
Who may be able to join
- Diagnosed with any type of headache,
- Have a chronic headache.
Who cannot join
- Having a cognitive and neurological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to investigate cultural adaptation, reliability and validity of the Turkish version of the Headache Impact Questionnaire (HIQ).
Read the detailed description
The episodic nature of migraine attacks presents a number of difficulties in characterizing disease severity. There are differences in the severity, frequency and intensity of attacks and the general effect of the disease in individuals. Information about any particular attack is not sufficient to characterize the overall severity of the disease. Accordingly, the Headache Impact Questionnaire (HIQ) was developed to evaluate the headache experience over a period of time instead of any headache. Developed to measure the impact and quality of life of individuals suffering from headache, hıq evaluates the frequency and duration of headache, the degree of pain severity, daily life activities, disruptions in work or school life, the influence of the individual's leisure activities and other symptoms that may occur. HIQ consists of 16 items and the higher the score shows the seriousness of the impact. The study is planned with 80 individuals with complaint of headache. After questioning the sociodemographic characteristics of the individuals, the patients will be asked to fill in HIQ, Migraine Disability Assessment Questionnaire, Headache Impact Test-6 and Short Form-36.Test-retest will be re-applied to those of the same individuals who can be reached after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.
- Conditions
- Headache, Headache Disorders, Headache, Migraine, Headache, Tension, Headaches Chronic, Headaches Muscular
- Being tested
- Survey study
- Keywords
- Headache, Reliability, Validity, Cross-cultural adaptation
- Medical subject headings
- Headache, Headache Disorders, Migraine Disorders, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey studyOther
Headache Impact Questionnaire (HIQ) will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Patients group | Individuals with headache Receives: Other: Survey study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Impact Questionnaire (HIQ)
Headache Impact Questionnaire is designed to measure the quality of life related to the disability
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Nov 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime ARIKAN, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765501
- Sponsor's protocol ID
- 83116987-555
- Status last verified
- Oct 2022
- First submitted
- 19 Feb 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Headache Impact Questionnaire
- ClinicalTrials.gov ID
- NCT04765501
- Acronym / sponsor ID
- 83116987-555
- Conditions
- Headache, Headache Disorders, Headache, Migraine, Headache, Tension, Headaches Chronic, Headaches Muscular
- Keywords
- Headache, Reliability, Validity, Cross-cultural adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate cultural adaptation, reliability and validity of the Turkish version of the Headache Impact Questionnaire (HIQ).
Detailed description
The episodic nature of migraine attacks presents a number of difficulties in characterizing disease severity. There are differences in the severity, frequency and intensity of attacks and the general effect of the disease in individuals. Information about any particular attack is not sufficient to characterize the overall severity of the disease. Accordingly, the Headache Impact Questionnaire (HIQ) was developed to evaluate the headache experience over a period of time instead of any headache. Developed to measure the impact and quality of life of individuals suffering from headache, hıq evaluates the frequency and duration of headache, the degree of pain severity, daily life activities, disruptions in work or school life, the influence of the individual's leisure activities and other symptoms that may occur. HIQ consists of 16 items and the higher the score shows the seriousness of the impact. The study is planned with 80 individuals with complaint of headache. After questioning the sociodemographic characteristics of the individuals, the patients will be asked to fill in HIQ, Migraine Disability Assessment Questionnaire, Headache Impact Test-6 and Short Form-36.Test-retest will be re-applied to those of the same individuals who can be reached after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Other: Survey studyIndividuals with headache |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals with any type of headache.
Key inclusion criteria (2 listed)
- Diagnosed with any type of headache,
- Have a chronic headache.
Key exclusion criteria (1 listed)
- Having a cognitive and neurological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey studyHeadache Impact Questionnaire (HIQ) will be applied. | Other | Patients group |
Primary outcome
Headache Impact Questionnaire (HIQ)
Time frame: 15 minutes
Headache Impact Questionnaire is designed to measure the quality of life related to the disability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache and Headache Disorders, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Impact Questionnaire (HIQ) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.