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

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

      • Tokat, Turkey, 60250
        • Tokat Gaziosmanpasa University

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
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.
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.
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.

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

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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