MigraineNCT06675279
Psychometric Properties of the Turkish Version of the HANA in Migraine
An observational study of Migraine, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Migraine is one of the most common neurological disorders, affecting numerous adults. Headaches are often associated with significant disruptions that can interrupt the patient's usual activities for hours. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Survey-based study
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Sep 2024
- How long will I take part?
- 1 Month
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with migraine
Who may be able to join
- Having a diagnosis of chronic migraine (headaches occurring on more than 15 days per month for over three months, with migraine headaches on at least eight days per month),
- Being between 18 and 65 years of age,
- Experiencing neck pain during migraine attacks.
Who cannot join
- Having a diagnosis of any headache disorder other than chronic migraine,
- Having a history of any systemic disease, such as malignancy, inflammatory conditions, acute fractures, surgical history, neurological, psychological, or rheumatological disorders.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpaşa University
Tokat Province, Tokat Province, 60250
About this study
Official title: The Headache Needs Assessment (HANA) Survey: Psychometric Properties of the Turkish Version in Migraine
Migraine is one of the most common neurological disorders, affecting numerous adults. Headaches are often associated with significant disruptions that can interrupt the patient's usual activities for hours. Although headaches are typically episodic, many individuals with migraine experience life restrictions due to the anticipation of future attacks and the prevalent concern that headaches will compromise their functional capabilities. Several health-related quality of life scales have been developed to assess migraine and its associated conditions. Some examples include the Migraine-Specific Quality of Life Questionnaire, the Quality of Life and Migraine Scale, and the Migraine-Specific Quality of Life Measure. While some of these scales have Turkish versions, others do not. Many of these instruments are designed for clinical research, offering comprehensive assessment but are disadvantaged by lengthy completion and scoring times for patients. There is a need for brief health status measures with simple scoring systems that can evaluate the overall impact of migraines on daily activities. The Headache Needs Assessment (HANA) is a seven-item questionnaire developed to assess migraine-related quality of life issues.
This study aims to validate and establish the reliability of the Turkish version of the Headache Needs Assessment for evaluating individuals with migraines. If proven valid and reliable, the Headache Needs Assessment will be a practical tool for assessing the quality of life in individuals with migraines.
Read more
Null Hypothesis (H0): The Turkish version of the Headache Needs Assessment is not valid and reliable.
Alternative Hypothesis (H1): The Turkish version of the Headache Needs Assessment is valid and reliable.
Read the detailed description
Migraine is a serious health problem that disrupts quality of life and ranks second among primary headaches, affecting over 10% of the general population. In Turkey, the lifetime prevalence of migraine is reported to be 16%, with rates of 10.9% in men and 21.8% in women. Migraine is characterized by episodic attacks that may include headaches accompanied by vomiting, nausea, phonophobia, or photophobia. Chronic migraine is defined as a headache occurring on 15 or more days per month for over three months, with migraine features present on at least 8 of those days. The International Classification of Headache Disorders criteria for migraine require only two of four commonly seen pain features; thus, a non-throbbing, bilateral headache can still meet migraine criteria if it is moderate to severe, worsens with physical activity, and is accompanied by migraine-specific symptoms. Neck pain related to stress, which is sometimes associated with tension-type headache, is also a common feature of migraine.
Measurements play a crucial role in scientific research across various fields, including natural sciences, social sciences, and health sciences. In the biomedical sciences, many clinical conditions, psychological behaviors, attitudes, and beliefs are challenging to measure accurately. These may include disease severity, disease-related quality of life, pain perception, anxiety, and more. To quantify and assess specific attributes, researchers develop tools known as "scales" that consist of various components. Clinical scales are tools used in medicine to evaluate different aspects of a patient's health, including physical and mental health symptoms, functional abilities, and overall quality of life.
The Headache Needs Assessment (HANA) is designed to assess two dimensions of the chronic impact of migraine-related quality of life issues: frequency and discomfort. It comprises seven items and serves as a useful screening tool for evaluating the impact of migraine on individuals. Its two-dimensional approach to patient-reported quality of life enables individuals to weigh the influence of both the frequency and discomfort of chronic migraines on various aspects of daily life. This scale will fill a gap in the Turkish literature regarding the parameters it evaluates and will serve as a valuable tool in the field.
- Conditions
- Migraine
- Being tested
- Survey-based study
- Keywords
- Headache Needs Assessment, Migraine, Turkish
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey-based studyOther
The demographic information of individuals with migraines, along with data from the Visual Analog Scale, Migraine Disability Assessment Questionnaire, Headache Impact Test, Henry Ford Hospital Headache Disability Inventory, and Headache Needs Assessment, will be collected and analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with migraine | The demographic information of individuals with migraines, along with data from the Visual Analog Scale, Migraine Disability Assessment Questionnaire, Headache Impact Test-6, Henry Ford Hospital Headache Disability Inventory, and Headache Needs Assessment, will be collected and analyzed. Receives: Other: Survey-based study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Needs Assessment Survey
The Headache Needs Assessment consists of seven items that evaluate areas such as anxiety/worry, depression/discouragement, self-control, energy, functioning/work, family/social activities, and the overall impact of migraine. A distinctive feature of the questionnaire is that it separates responses into two categories: (1) How often did this issue occur? (1= Never, 2= Rarely, 3= Sometimes, 4= Often, 5= Always); and (2) How much did this issue bother you? (1= Not at all, 2= A little, 3= Somewhat, 4= Quite a bit, 5= Very much). The total score ranges from 14 to 70, with higher scores indicating a more negatively impacted quality of life.
Measured: through study completion, an average of 6 months
Secondary outcomes (4)
Visual Analog Scale
Headache severity was assessed using the Visual Analog Scale (VAS). A 10 cm horizontal line was drawn with a ruler for the VAS, where the beginning of the line (0 cm) was described to patients as "no pain," and the end of the line (10 cm) was described as "unbearable, severe pain." Patients were asked to mark a point on the line that best represented the intensity of their headache. The distance from the starting point to the marked point was then measured and recorded as the headache severity.
Measured: through study completion, an average of 6 months
Migraine Disability Assessment Questionnaire
Disability related to migraines was assessed using the Migraine Disability Assessment Questionnaire (MIDAS). MIDAS evaluates disability over the past three months and consists of a five-item, self-administered test that addresses work/school-related disability, household chores, and family, social, or leisure activities. The total score is calculated based on the number of days missed in these activities, classifying disability as minimal (0-5 points), mild (6-10 points), moderate (11-20 points), or severe (≥21 points). The validity, reliability, and Turkish version of the questionnaire were established by Ertaş et al.
Measured: through study completion, an average of 6 months
Headache Impact Test-6
The Headache Impact Test-6 (HIT-6) is a quality of life questionnaire for headaches that evaluates vitality, pain, psychological distress, social functioning, role limitations, and cognitive functioning. Each item is scored on a 5-point Likert scale (6 = never, 8 = rarely, 10 = sometimes, 11 = very often, 13 = always). The total score is determined by summing the scores of all six items, ranging from 36 to 78. The scores are categorized as follows: ≤49 = little to no impact, 50-55 = some impact, 56-59 = substantial impact, and 60-78 = severe impact, with higher scores indicating greater impairment in quality of life. The validity, reliability, and Turkish version of the questionnaire have been established.
Measured: through study completion, an average of 6 months
Henry Ford Hospital Headache Disability Inventory
The Henry Ford Hospital Headache Disability Inventory is a 25-item questionnaire that examines the impact of headaches on daily life. The inventory has a two-dimensional structure, comprising emotional and functional components. Each item is scored as No: 0, Sometimes: 2, and Yes: 4. The total score ranges from 0 to 100, with higher scores indicating greater headache-related disability. The validity, reliability, and Turkish version of the inventory were developed by Kılınç et al.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 79 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime Arikan, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675279
- Sponsor's protocol ID
- 83116987-155
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arikan H, Onan D, Kulu U. The Headache Needs Assessment (HANA) survey: psychometric properties of the Turkish version in migraine. Cranio. 2026 Jul 13:1-9. doi: 10.1080/08869634.2026.2703773. Online ahead of print.
PubMed 42439599
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Headache Needs Assessment (HANA) Survey: Psychometric Properties of the Turkish Version in Migraine
- ClinicalTrials.gov ID
- NCT06675279
- Acronym / sponsor ID
- 83116987-155
- Conditions
- Migraine
- Keywords
- Headache Needs Assessment, Migraine, Turkish
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 5 Nov 2024 (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.
Migraine is one of the most common neurological disorders, affecting numerous adults. Headaches are often associated with significant disruptions that can interrupt the patient's usual activities for hours. Although headaches are typically episodic, many individuals with migraine experience life restrictions due to the anticipation of future attacks and the prevalent concern that headaches will compromise their functional capabilities. Several health-related quality of life scales have been developed to assess migraine and its associated conditions. Some examples include the Migraine-Specific Quality of Life Questionnaire, the Quality of Life and Migraine Scale, and the Migraine-Specific Quality of Life Measure. While some of these scales have Turkish versions, others do not. Many of these instruments are designed for clinical research, offering comprehensive assessment but are disadvantaged by lengthy completion and scoring times for patients. There is a need for brief health status measures with simple scoring systems that can evaluate the overall impact of migraines on daily activities. The Headache Needs Assessment (HANA) is a seven-item questionnaire developed to assess migraine-related quality of life issues.
This study aims to validate and establish the reliability of the Turkish version of the Headache Needs Assessment for evaluating individuals with migraines. If proven valid and reliable, the Headache Needs Assessment will be a practical tool for assessing the quality of life in individuals with migraines.
Null Hypothesis (H0): The Turkish version of the Headache Needs Assessment is not valid and reliable.
Alternative Hypothesis (H1): The Turkish version of the Headache Needs Assessment is valid and reliable.
Detailed description
Migraine is a serious health problem that disrupts quality of life and ranks second among primary headaches, affecting over 10% of the general population. In Turkey, the lifetime prevalence of migraine is reported to be 16%, with rates of 10.9% in men and 21.8% in women. Migraine is characterized by episodic attacks that may include headaches accompanied by vomiting, nausea, phonophobia, or photophobia. Chronic migraine is defined as a headache occurring on 15 or more days per month for over three months, with migraine features present on at least 8 of those days. The International Classification of Headache Disorders criteria for migraine require only two of four commonly seen pain features; thus, a non-throbbing, bilateral headache can still meet migraine criteria if it is moderate to severe, worsens with physical activity, and is accompanied by migraine-specific symptoms. Neck pain related to stress, which is sometimes associated with tension-type headache, is also a common feature of migraine.
Measurements play a crucial role in scientific research across various fields, including natural sciences, social sciences, and health sciences. In the biomedical sciences, many clinical conditions, psychological behaviors, attitudes, and beliefs are challenging to measure accurately. These may include disease severity, disease-related quality of life, pain perception, anxiety, and more. To quantify and assess specific attributes, researchers develop tools known as "scales" that consist of various components. Clinical scales are tools used in medicine to evaluate different aspects of a patient's health, including physical and mental health symptoms, functional abilities, and overall quality of life.
The Headache Needs Assessment (HANA) is designed to assess two dimensions of the chronic impact of migraine-related quality of life issues: frequency and discomfort. It comprises seven items and serves as a useful screening tool for evaluating the impact of migraine on individuals. Its two-dimensional approach to patient-reported quality of life enables individuals to weigh the influence of both the frequency and discomfort of chronic migraines on various aspects of daily life. This scale will fill a gap in the Turkish literature regarding the parameters it evaluates and will serve as a valuable tool in the field.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with migraine | – | Other: Survey-based studyThe demographic information of individuals with migraines, along with data from the Visual Analog Scale, Migraine Disability Assessment Questionnaire, Headache Impact Test-6, Henry Ford Hospital Headache Disability Inventory, and Headache Needs Assessment, will be collected and analyzed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with migraine
Key inclusion criteria (3 listed)
- Having a diagnosis of chronic migraine (headaches occurring on more than 15 days per month for over three months, with migraine headaches on at least eight days per month),
- Being between 18 and 65 years of age,
- Experiencing neck pain during migraine attacks.
Key exclusion criteria (2 listed)
- Having a diagnosis of any headache disorder other than chronic migraine,
- Having a history of any systemic disease, such as malignancy, inflammatory conditions, acute fractures, surgical history, neurological, psychological, or rheumatological 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-based studyThe demographic information of individuals with migraines, along with data from the Visual Analog Scale, Migraine Disability Assessment Questionnaire, Headache Impact Test, Henry Ford Hospital Headache Disability Inventory, and Headache Needs Assessment, will be collected and analyzed. | Other | Individuals with migraine |
Primary outcome
Headache Needs Assessment Survey
Time frame: through study completion, an average of 6 months
The Headache Needs Assessment consists of seven items that evaluate areas such as anxiety/worry, depression/discouragement, self-control, energy, functioning/work, family/social activities, and the overall impact of migraine. A distinctive feature of the questionnaire is that it separates responses into two categories: (1) How often did this issue occur? (1= Never, 2= Rarely, 3= Sometimes, 4= Often, 5= Always); and (2) How much did this issue bother you? (1= Not at all, 2= A little, 3= Somewhat, 4= Quite a bit, 5= Very much). The total score ranges from 14 to 70, with higher scores indicating a more negatively impacted quality of life.
4 secondary outcomes
Visual Analog Scale
Time frame: through study completion, an average of 6 months
Migraine Disability Assessment Questionnaire
Time frame: through study completion, an average of 6 months
Headache Impact Test-6
Time frame: through study completion, an average of 6 months
Henry Ford Hospital Headache Disability Inventory
Time frame: through study completion, an average of 6 months
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 5 Nov 2024.
- Derived from this study: PubMed 42439599Arikan H, Onan D, Kulu U. The Headache Needs Assessment (HANA) survey: psychometric properties of the Turkish version in migraine. Cranio. 2026 Jul 13:1-9. doi: 10.1080/08869634.2026.2703773. Online ahead of print.
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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 Migraine, run by Tokat Gaziosmanpasa 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 3 inclusion and 2 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 5 Nov 2024. 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 Needs Assessment Survey (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06675279, which also lists 1 linked publication.
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 5 Nov 2024.