Evaluation of Kinesiophobia in Patients With Headache Using the Tampa Kinesiophobia Scale Modified for Headache: Turkish Version, Validity and Reliability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 329
- 试验地点
- 13
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Tampa Kinesiophobia Scale is a scale that has been validated and reliable in individuals with low back pain in the Turkish population and evaluates fear of movement due to the risk of triggering pain. Especially for migraine headache, patients have complaints about movement and fear of movement, and in addition, according to the International Classification of Headache Disorders, 3rd Edition criteria, the item of aggravation with physical activity is considered as a diagnostic criterion. Migraine patients may theoretically start their attacks due to hypocretin neuropeptide and lactate metabolism dysfunction. It has been stated that calcitonin gene-related peptide (CGRP), which is released during migraine attacks, is also released during exercise and intense physical activity and can trigger attacks. Therefore, patients avoid physical activity and exercise. It has been stated that movements that do not require effort can also trigger attacks in migraine patients. The aim of this study is to investigate the validity and reliability of the Tampa Kinesiophobia Scale for Headache in patients with migraine for the Turkish population. The potential relationships between the scale and the beliefs about headache intensity, disability, headache impact, anxiety and depression will also be evaluated and whether the characteristics of the three types of headaches are similar or different from kinesiophobia will be investigated.
Hypothesis:
H0: The Tampa Kinesiophobia Scale for Headache is not valid and reliable for the Turkish population in patients with migraine H1: The Tampa Kinesiophobia Scale for Headache is valid and reliable for the Turkish population in patients with migraine
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with episodic/chronic migraine,
- •Being between the ages of 18-70,
- •Being able to read, speak, understand and write Turkish in order to understand and correctly answer the items/questions of the surveys and scales.
排除标准
- •Having a diagnosis of episodic/chronic migraine,
- •Having a history of any systemic disease such as malignant, inflammatory, acute fracture, surgery, neurological, psychological, or rheumatological.
- •Not being able to read Turkish.
结局指标
主要结局
Visual Analog Scale
时间窗: In first enrollment, 1 minute
The visual analog scale consists of the pain level that the person currently experiences with a vertical line on a plane. The pain felt by the person is marked as "0: no pain at all", "10: I feel very severe pain". Scoring is based on the vertical marking the participant makes for the pain he/she marks on the plane with a ruler.
Migraine Disability Assessment Questionnaire
时间窗: In first enrollment, 1 minute
Disability of migraine patients will be assessed with the Migraine Disability Assessment Questionnaire (MEDA). MEDA assesses the last 3 months of disability and consists of a 5-item self-administered test covering disability-related activities at work/school, housework, family, and social or leisure. The total number of days missed in these activities is the total score and classifies disability as minimal disability (0-5 points), mild disability (6-10 points), moderate disability (11-20 points), or severe disability (≥21).
Headache Impact Test-6
时间窗: In first enrollment, 3 minutes
The impact of headache will be assessed with the Headache Impact Test-6 (HIT-6). HIT-6 is a quality of life questionnaire for headaches that assesses vitality, pain, psychological distress, sociability, role, 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 determined by summing the scores on the six items and ranges from 36 to 78 points. (≤49 = little/no impact, 50-55 = some impact, 56-59 = significant impact, and 60-78 = severe impact; higher scores indicate greater deterioration in quality of life).
Hospital Anxiety and Depression Scale
时间窗: In first enrollment, 3 minutes
Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS). 7 items of the 14-item scale assess anxiety and 7 items assess depression symptoms. It is scored between 0-3 points. By summing the subscale scores, 0-21 points can be obtained from each of the Depression and Anxiety subscales. It is stated that 0-7 points are the normal range for each subscale, 8-10 points suggest the presence of a mood disorder, and 11 and above points indicate a possible mood disorder. In addition, there are recommended cut-off scores for mild (8-10 points), moderate (11-15) and severe (16 and above) cases.
次要结局
未报告次要终点
研究者
Dilara Onan
Assistant Professor
Bozok University