Tension Type HeadacheNCT06675292
Psychometric Properties of the Turkish Version of the HANA in Tension Type Headache
An observational study of Tension Type Headache, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Individuals with tension type headache Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension Type Headache
- What is being tested?
- Survey-based study
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Nov 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 tension type headache
Who may be able to join
- Having a diagnosis of tension-type headache,
- Being between 18 and 65 years of age.
Who cannot join
- Having a diagnosis of any headache disorder other than tension-type headache,
- Having a history of any systemic disease, such as malignancy, inflammatory conditions, acute fractures, surgical history, or neurological, psychological, or rheumatological disorders.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpaşa University
Tokat Province, 60250
About this study
Official title: Psychometric Properties of the Headache Needs Assessment (HANA) Survey in Tension Type Headache: Turkish Version, Reliability, and Validity Study
Individuals with tension type headache
- Conditions
- Tension Type Headache
- Being tested
- Survey-based study
- Keywords
- Headache Needs Assessment Survey, Tension type headache, Turkish
- Medical subject headings
- Tension-Type Headache
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 tension-type headaches, 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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with tension type headache | Not described 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 unique aspect 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 = A lot, 5 = Very much). The total score ranges from 14 to 70, with higher scores indicating a greater negative impact on quality of life.
Measured: through study completion, an average of 1 month
Secondary outcomes (3)
Visual Analog Scale
Headache severity will be assessed using the Visual Analog Scale (VAS). For the VAS, a 10 cm horizontal line is drawn with a ruler. The beginning of the line (0 cm) is described to patients as "no pain," and the end of the line (10 cm) as "unbearable, severe pain." Patients are asked to mark a point on the line that best represents the intensity of their headache between these two endpoints. The distance from the starting point to the marked location is then measured and recorded as the headache severity.
Measured: through study completion, an average of 1 month
Headache Impact Test-6 (HIT-6)
Headache Impact Test-6 (HIT-6), a quality of life questionnaire for headaches that assesses 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 calculated by summing the scores of all six items, ranging from 36 to 78. 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 1 month
Henry Ford Hospital Headache Disability Inventory
The Henry Ford Hospital Headache Disability Inventory is a 25-item questionnaire designed to assess the impact of headaches on daily life. This inventory has a two-dimensional structure, comprising emotional and functional components. Items are 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 have been established by Kılınç et al.
Measured: through study completion, an average of 1 month
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 Oct 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 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 Tension Type HeadacheStudies 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
- 70 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
- Investigators
- Halime ARIKAN, Doctor of Philosophy, Principal investigator, Tokat Gaziosmanpaşa University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675292
- Sponsor's protocol ID
- 83116987-504
- Status last verified
- Nov 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. Psychometric properties of the headache needs assessment (HANA) survey in tension type headache: Turkish version, reliability, and validity study. Acta Neurol Belg. 2025 Aug;125(4):1091-1099. doi: 10.1007/s13760-025-02749-4. Epub 2025 Feb 24.
PubMed 39992579
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
- Psychometric Properties of the Headache Needs Assessment (HANA) Survey in Tension Type Headache: Turkish Version, Reliability, and Validity Study
- ClinicalTrials.gov ID
- NCT06675292
- Acronym / sponsor ID
- 83116987-504
- Conditions
- Tension Type Headache
- Keywords
- Headache Needs Assessment Survey, Tension type headache, Turkish
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 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.
Individuals with tension type headache
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with tension type headache | – | Other: Survey-based study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with tension type headache
Key inclusion criteria (2 listed)
- Having a diagnosis of tension-type headache,
- Being between 18 and 65 years of age.
Key exclusion criteria (2 listed)
- Having a diagnosis of any headache disorder other than tension-type headache,
- Having a history of any systemic disease, such as malignancy, inflammatory conditions, acute fractures, surgical history, or 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 tension-type headaches, 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. | Other | Individuals with tension type headache |
Primary outcome
Headache Needs Assessment Survey
Time frame: through study completion, an average of 1 month
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 unique aspect 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 = A lot, 5 = Very much). The total score ranges from 14 to 70, with higher scores indicating a greater negative impact on quality of life.
3 secondary outcomes
Visual Analog Scale
Time frame: through study completion, an average of 1 month
Headache Impact Test-6 (HIT-6)
Time frame: through study completion, an average of 1 month
Henry Ford Hospital Headache Disability Inventory
Time frame: through study completion, an average of 1 month
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 39992579Arikan H, Onan D, Kulu U. Psychometric properties of the headache needs assessment (HANA) survey in tension type headache: Turkish version, reliability, and validity study. Acta Neurol Belg. 2025 Aug;125(4):1091-1099. doi: 10.1007/s13760-025-02749-4. Epub 2025 Feb 24.
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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.
Halime ARIKAN, Doctor of Philosophy principal investigator
Tokat Gaziosmanpaşa University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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 Tension Type Headache, 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 2 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 1 month). 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 NCT06675292, 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.