Psychometric Properties of the Turkish Version of the HANA in Migraine

NCT06675279 | Completed

• 1 other identifier: 83116987-155
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Headache Needs Assessment; Migraine; Turkish

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 6 months

Secondary Outcomes (4)

• Visual Analog Scale

  through study completion, an average of 6 months

• Migraine Disability Assessment Questionnaire

  through study completion, an average of 6 months

• Headache Impact Test-6

  through study completion, an average of 6 months

• Henry Ford Hospital Headache Disability Inventory

  through study completion, an average of 6 months

Study Arms (1)

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.

Other: Survey-based study

Interventions

Survey-based study OTHER

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.

Individuals with migraine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with migraine

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat Province, Tokat Province, 60250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 5, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-03

Locations

TU (1)