Clinical trial NCT06675279: Psychometric Properties of the Turkish Version of the HANA in Migraine
Official title: The Headache Needs Assessment (HANA) Survey: Psychometric Properties of the Turkish Version in Migraine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: Headache Needs Assessment
Migraine
Turkish
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with migraine

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Headache Needs Assessment Survey
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: through study completion, an average of 6 months
measure: Migraine Disability Assessment Questionnaire
timeFrame: through study completion, an average of 6 months
measure: Headache Impact Test-6
timeFrame: through study completion, an average of 6 months
measure: Henry Ford Hospital Headache Disability Inventory
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpaşa University
Study officials:
References: