Psychometric Properties of the Turkish Version of the HANA in Tension Type Headache

Completed

• Conditions: Tension Type Headache

• Registration Number: NCT06675292
• Lead Sponsor: Tokat Gaziosmanpasa University

Brief Summary

Individuals with tension type headache

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-01
• Status Verified: 2024-11
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Study First Submitted: 2024-11-02
• Study First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Headache Needs Assessment Survey	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.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale	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.
Headache Impact Test-6 (HIT-6)	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.
Henry Ford Hospital Headache Disability Inventory	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.

Trial Locations

Locations (1)

Tokat Gaziosmanpaşa University; 🇹🇷 Tokat, Turkey