- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06675292
Psychometric Properties of the Turkish Version of the HANA in Tension Type Headache
November 4, 2024 updated by: Halime ARIKAN, Tokat Gaziosmanpasa University
Psychometric Properties of the Headache Needs Assessment (HANA) Survey in Tension Type Headache: Turkish Version, Reliability, and Validity Study
Individuals with tension type headache
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tokat, Turkey, 60250
- Tokat Gaziosmanpasa University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Individuals with tension type headache
Description
Inclusion Criteria:
- Having a diagnosis of tension-type headache,
- Being between 18 and 65 years of age.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Individuals with tension type headache
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
through study completion, an average of 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: through study completion, an average of 1 month
|
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.
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through study completion, an average of 1 month
|
|
Headache Impact Test-6 (HIT-6)
Time Frame: through study completion, an average of 1 month
|
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.
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through study completion, an average of 1 month
|
|
Henry Ford Hospital Headache Disability Inventory
Time Frame: through study completion, an average of 1 month
|
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.
|
through study completion, an average of 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Halime ARIKAN, Doctor of Philosophy, Tokat Gaziosmanpaşa University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Actual)
November 1, 2024
Study Completion (Actual)
November 1, 2024
Study Registration Dates
First Submitted
November 2, 2024
First Submitted That Met QC Criteria
November 4, 2024
First Posted (Estimated)
November 5, 2024
Study Record Updates
Last Update Posted (Estimated)
November 5, 2024
Last Update Submitted That Met QC Criteria
November 4, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 83116987-504
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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