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临床试验/NCT06658457
NCT06658457已完成不适用

Investigation of Factors That May Affect Headache in Individuals With Juvenile Onset Systemic Lupus Erythematosus

Pamukkale University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
McGill Melzack Pain Questionnaire

研究概览

简要总结

The aim of our study was to compare individuals with juvenile onset systemic lupus erythematosus with and without headache in terms of pain, pain catastrophizing behavior, demographic and individual disease-related factors that may affect headache and temporomandibular joint dysfunction.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
8 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Having been diagnosed with Juvenile Onset Systemic Lupus Erythematosus by the Pediatric Rheumatology Clinic
  • Being between the ages of 8-25,
  • Having stable symptoms and medications
  • Being willing to participate in the study

排除标准

  • Patients with neuropsychiatric disorders not associated with Juvenile Onset Systemic Lupus Erythematosus (such as history of epilepsy, electrolyte imbalance, or medication side effects)
  • History of headache before juvenile onset systemic lupus erythematosus diagnosis
  • Presence of another concomitant rheumatic disease
  • Having cognitive impairment to the extent of not being able to cooperate

结局指标

主要结局

McGill Melzack Pain Questionnaire

时间窗: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

McGill Melzack Pain Questionnaire consists of four sections. The total score is between 0 and 78 As the score increases, the pain level worsens.

Pain Catastrophizing Scale for Children

时间窗: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Pain Catastrophizing Scale for Children is a revised questionnaire consisting of 13 items. Scores range from 0 to 52. Higher score indicate that worse catastrophizing.

Pain Catastrophizing Scale for Parents

时间窗: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

It consists of 13 items. The scores range from 0 to 52. Higher score indicate that worse catastrophizing.

Fonseca Anamnestic Questionnaire

时间窗: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Temporomandibular joint dysfunction was assessed using the Fonseca Anamnestic Questionnaire. The Fonseca Anamnestic Questionnaire consists of 10 questions. The participant is asked to answer each question as 'Yes' (10 points), 'No' (0 points) and 'Sometimes' (5 points). The questionnaire score is scored for all questions and the severity of Temporomandibular joint dysfunction is classified according to the total score. It is classified as no Temporomandibular joint dysfunction (0-15 points), mild Temporomandibular joint dysfunction (20-40 points), moderate Temporomandibular joint dysfunction (45-65 points), severe Temporomandibular joint dysfunction (70-100).

Demographic and disease-related data

时间窗: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Such as forehead pain, jaw pain, sore throat, ear pain, neck pain, shoulder pain, psychiatric support, parental togetherness, parents being involved in the child's life, use of vitamin supplements, history of hospitalization due to headache, previous surgery, hearing problems, recurrent sinus infection, recurrent sore throat, asthma, snoring, snoring during sleep, vomiting with headache, reflux, recurrent stomach pain, numbness and tingling with headache, easy bleeding and bruising, eating disorder, frequent nosebleeds, diabetes, obesity, sudden weight loss were recorded as 'yes/no'.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zülal TATAR

Researcher

Pamukkale University

研究点 (1)

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