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临床试验/NCT06077006
NCT06077006已完成不适用

Executive Functions, Anxiety and Their Relation to Social Participation and Quality of Life Among Children With Migraine During COVID-19

Bnai Zion Medical Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年4月1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
150
试验地点
1
主要终点
The Pediatric Quality of Life Inventory (PedsQL(

研究概览

简要总结

Executive functions, anxiety and their relation to social participation and quality of life among children with Migraine during COVID-19

Backgrounds: Among children, especially adolescents, migraine stands out as one of the most prevalent headache disorders. It is susceptible to stress and has the potential to affect children's emotional and cognitive status and therefore, affect their function, and notably amid the COVID-19 pandemic.

Study Objective: To compare executive functions (EF), anxiety, social participation and quality of life (QoL) between children with migraine and healthy controls, and to examine the differences of these factors between children who were infected by COVID-19 and those who were not.

Study Population:

The research will include 75 children between the ages of 6 and 18 years, diagnosed with Migraine, who are under follow-up at the Pediatric Neurology Clinic in Bnei Zion. A control group of 75 children without chronic diseases, assessed during routine visits at the Pediatric Neurology Clinic or for other reasons, will also be included.

Research Methods:

Participants will complete questionnaires related to demographic details, quality of life, sleep, and emotional status.

Inclusion Criteria:

Children between the ages of 6 and 18 years with Migraine.

Exclusion Criteria:

Children unable or unwilling to complete the questionnaires, and those with secondary headaches or other chronic illness.

Informed Consent:

Participants aged 11 and older will provide informed consent, while younger children will receive oral explanations, and their paren

详细描述

Executive functions, anxiety and their relation to social participation and quality of life among children with Migraine during COVID-19

Background:

Headaches are a frequent occurrence in children and adolescents, making them the most commonly reported pain complaint when seeking medical attention. (Genizi 2013) The prevalence of migraine shows an increase from 3% during the preschool years to 23% during high school years. (Al-Twaijri 2002) The COVID-19 pandemic has profoundly affected the well-being of children and adolescents, impacting various facets of their physical and mental health. Disrupted routines, prolonged periods of social isolation, increased screen time, and heightened stress and anxiety related to the pandemic have raised concerns about the potential amplification in frequency and severity of childhood migraines. Numerous studies have documented an upsurge in migraine symptoms and frequency among children during the pandemic.( Bonuccelli 2023, Dedeoglu 2023 Caronna 2023) Factors such as changes in sleep patterns, dietary habits, physical activity levels, and emotional stress contribute to the worsening of migraine in this population. ( Powers 2003, Riva 2006) Additionally, restricted access to healthcare services and disrupted follow-up care during the pandemic pose challenges for the management and treatment of childhood migraine. (Apetti 2020, Verhagen 2021, Reyes-Alvarez 2023) It is imperative for healthcare professionals to acknowledge these difficulties and provide appropriate support and interventions to mitigate the pandemic's impact on children with migraine. Future research should delve into the underlying mechanisms connecting pandemic-related factors to the exacerbation of migraine, enabling the development of targeted strategies for prevention and management.

Our study aimed to explore COVID-19 pandemic on the executive functions (EF), and quality of life of children with migraine and healthy controls. We compared EF between children with migraine and healthy controls. Then, both groups were further divided to children who were affected by COVID-19 those who were not affected by COVID-19. Comparisons within and between groups of EF, anxiety, participation and QOL were performed. Among children with migraine, we examined the implications of COVID-19 restrictions on EF; we examined the correlations between EF, anxiety, participation and QOL. Based on the correlations results, we examined whether EF, anxiety, migraine severity and participation predicted QOL.

Research Objective:

研究设计

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

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between the ages of 6 and 18 years with Migraine.

排除标准

  • Children unable or unwilling to complete the questionnaires, and those with secondary headaches or other chronic illness.

结局指标

主要结局

The Pediatric Quality of Life Inventory (PedsQL(

时间窗: 12 months

Children's Health-Related Quality of Life (HRQoL) in four dimensions: (1) Physical Functioning (eight items), (2) Emotional Functioning (five items), (3) Social Functioning (five items) and (4) School Functioning (five items) among migraine group is worse compared to the control.

Behavior Rating Inventory of Executive Functions (BRIEF)

时间窗: 12 months

Executive Functions as expressed in daily life situations among migraine group is worse compared to the control.

次要结局

未报告次要终点

研究者

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

Jacob.genizi

Director Pediatric Département

Bnai Zion Medical Center

研究点 (1)

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