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临床试验/NCT05454826
NCT05454826已完成不适用

Investigation of the Effect of Cold Application in Addition to Relaxation Exercises in Patients with Migraine

Eylül Pınar KISA2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
2
主要终点
Migraine Disability Assessment questionnaire

研究概览

简要总结

Migraine is a headache that is paroxysmal and can last for hours, sometimes even days due to untreated or ineffective treatment is usually unilateral, throbbing, severe enough to prevent the person's daily life activities, and increases with head movements. It is a chronic disorder characterized by recurrent moderate and severe headaches, mostly associated with a few symptoms in the autonomic nervous system. Migraine consists of recurrent headache attacks accompanied by neurological, gastrointestinal, and autonomic symptoms.

Migraine is the most common chronic headache in epidemiological studies. Studies have shown that migraine affects 12% of the general population. The aim of migraine treatment is to reduce the frequency, duration, and severity of migraine attacks, to reduce the losses caused by migraine, and increase the quality of life.

In the treatment of migraine, non-pharmacological treatment is as important as pharmacological treatment. Some individuals prefer drug-free treatment methods because of the side effects drugs. In recent years, as the mechanisms of headaches have been better understood, significant developments have been made in treatment methods. Different physiotherapy and rehabilitation methods have been used for treatment. There are studies in which cold application is used in migraine patients, but a study evaluating the effectiveness of cold application has not been found in the literature. The systemic effects of cold have two main purposes: to maintain the current body temperature and to produce energy to raise the fallen body temperature. Knowing both the local and systemic effects of cold guides its use in treatment. The aim of this study was to diagnose migraine.

To investigate the effectiveness of cold application applied in addition to relaxation exercises in individuals.

详细描述

Thirty migraine patients diagnosed by a physician will be included in our study.

Participants will be divided into two groups as randomized controlled. Only relaxation exercises will be applied to a group for 6 weeks, 3 days a week. In the other group, relaxation In addition to the exercises, cold will be applied. The sociodemographic information of the patients will be evaluated with the "patient case form", the pain severity will be evaluated with the "visual analog scale" and the quality of life will be evaluated with the world health organization quality of life scale ('whoqol-bref').

Migraine disability rating scale (MIDAS) will be used for functionality. Statistical analysis of data SPSS It will be done using the 24.0 (Statistical Package for Social Sciences) program and p≤0.05 will be considered statistically significant in all analyzes.

The reason why the investigators chose cold application in addition to relaxation exercises in our study is that it is a low-cost, risk-free method that everyone can access. It is also an easy-to-apply method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • be between 20-45 years old
  • Having been diagnosed with migraine at least 6 months ago
  • Patient's ability to use a computer

排除标准

  • Being in the period of menstruation
  • Sensitivity to cold (those who have 5 or more sensitivity on a 10 cm scale)
  • Having any neurological or orthopedical problems
  • Using antidepressants etc.
  • Poor mental state

结局指标

主要结局

Migraine Disability Assessment questionnaire

时间窗: 0-6. week

The Migraine Disability Assessment questionnaire (MIDAS) questionnaire was developed to measure the effect of headaches on a person's daily functioning. MIDAS takes into account the last three months and consists of five questions. It is a simple and short survey. These questions are used to determine your score and are then matched to a disability level. As the score increases, the severity of migraine pain increases.

次要结局

  • World Health Organization quality of life scale ('whoqol-bref')(0-6. week)
  • Visual Analog Scale(0-6. week)
  • Patient case form(0-6. week)

研究者

发起方
Eylül Pınar KISA
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eylül Pınar KISA

Dr.

Biruni University

研究点 (2)

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