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临床试验/NCT06816849
NCT06816849已完成不适用

The Role of Hydration in the Management of Pediatric Primary Headaches: A Pilot Study

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Headache frequency

研究概览

简要总结

The aim of this study is to investigate the role of hydration and fluid intake in children and adolescents with primary headaches.

详细描述

Headches are one of the key factors affecting or even limiting the health and well-being of children and adolescents. Lifestyle recommendations could help reduce the risk of chronic headaches and improve overall well-being in this population. In clinical practice, adequate fluid intake is one of the general recommendations for headache management. However, scientific literature on the role of hydration and fluid intake in headaches is limited. To date, all studies have been conducted on adults, and no studies have examined this topic in the pediatric population.

As the first interventional study investigating the impact of adequate fluid intake on headaches in children and adolescents, our study will make a significant contribution to understanding the role of hydration in headache management and developing recommendations for improving headache control in the pediatric population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 4-18 years.
  • •Able to provide informed consent and willing to complete follow-up visits.
  • •Primary headaches.
  • •At least 1 headache per month.
  • •Presence of headaches for at least 3 months or longer.

排除标准

  • •Secondary headaches.
  • •Without headaches for 3 months or more.

研究组 & 干预措施

Recommended fluid intake

Experimental

All participants received personalized consultation from a dietitian on adequate fluid intake and the selection of drinks based on dietary guidelines. They were required to follow the intervention for four months.

干预措施: Recommended water intake (Other)

结局指标

主要结局

Headache frequency

时间窗: 4 months

Number of headache episodes over last three months.

Headache duration

时间窗: 4 months

Average length of headache episode measured in minutes.

Headache intensity

时间窗: 4 months

Headache severity measured with the Visual Analog Scale (0 - 10).

次要结局

  • Change in phase angle(4 months)
  • Change in total body water(4 months)
  • Effect of nutritional advice on type of drink they have choosen(4 months)
  • Change in extracellular water(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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