Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06077006
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2023-10-10
Brief Title:
The Impact of nCoV-2019 on Children With Migraine
Sponsor:
Bnai Zion Medical Center
Organization:
Bnai Zion Medical Center
Study Overview
Official Title:
Executive Functions Anxiety and Their Relation to Social Participation and Quality of Life Among Children With Migraine During COVID-19
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 childrens 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
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 childrens 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
Detailed Description:
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 pandemics 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
Our hypotheses were that 1 children with migraine would have significantly lower EF higher anxiety lower participation and QOL than healthy controls 2 When comparing children affected by COVID-19 those who were not affected by COVID-19 withing and between groups children with migraine who were affected by COVID-19 would have the lowest EF highest anxiety lowest participation and QOL 3 Among children with migraine significant correlations would be found between migraine severity Ped MIDAS EF anxiety participation and QOL 4 EF anxiety migraine severity and participation would significantly predict QOL
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
For the study group only
Medical Assessment A prospective medical history including a thorough headache history and physical and neurological assessment by a pediatric neurologist were done in all children during the visit at the pediatric neurology clinic All children met the diagnostic criteria for migraine according to the International Classification of Headache Disorders 3rd edition ICHD-3
PedMIDAS Headache related disability was evaluated by the PedMIDAS questionnaire It was developed to assess migraine disability in pediatric and adolescent patients and has been tested and validated for ages 4 to 18
For all participants
Health status questionnaire- A thorough questionnaire about the general health of all participants including information about COVID-19 - as whether the child was infected by the virus
Behavior Rating Inventory of Executive Functions BRIEF - The BRIEF is a behavioral rating measure for children and youth aged 5-18 years that aims to measure the childs EF as expressed in daily life situations for example becomes upset with new situations has a messy desk disturbed by change of teacher or class does not check work for mistakes has trouble concentrating on chores schoolwork In the present study we used the BRIEF parents report The BRIEF includes 86 items that measure various EF and are summarized into two scales Behavioral Regulation Index BRI which includes the inhibition shifting and emotional control scales and the Metacognition Index MI which includes the initiation working memory planning organization of materials and monitoring scales The Global Executive Composite GEC total score is generated from both BRI and MI scores Parents rate how frequent the child express the behavior described in each BRIEF item on a Likert scale that ranges from 1 infrequently to 3 often All row scores are converted to a standard scores A total cut-off standard score of 65 indicates deficiencies in executive functions As higher is the scores the worse are the EF The BRIEF has good psychometric properties Gioia et al 2015 Gioia Isquith Guy Kenworthy 2000 McGill Snow 2021
The State-Trait Anxiety Inventory for Children STAIC Spielberger C D Edwards C D Montouri J Lushene R 1973 distinguishes between a general proneness to anxious behavior rooted in the personality and anxiety as a fleeting emotional state The STAIC S-Anxiety scale consists of twenty statements that ask children how they feel at a particular moment in time The STAIC T-Anxiety scale also consists of 20 item statements but subjects respond to these items by indicating how they generally feel The instrument is designed to be used with upper elementary or junior high school aged children Higher mean score represents lower anxiety
The Child and Adolescent Scale of Participation CASP Bedell 2011 - measures the extent to which children participate in home school and community activities compared to children of the same age as reported by family caregivers The content and methods used in the CASP and CFFS were informed by the International Classification of Functioning ICF WHO 2001 research addressing participation of children youth with a range of disabilities and factors related to the child family and physical and social environment that support and or hinder participation The CASP consists of 20 ordinal-scaled items and four subsections 1 Home Participation 6 items 2 Community Participation 4 items 3 School Participation 5 items and 4 Home and Community Living Activities 5 items The 20 items are rated on a four-point scale Age Expected Full participation Somewhat Restricted Very Restricted Unable A Not Applicable response is selected when the item reflects an activity in which the child would not be expected to participate due to age eg work Most items are applicable to children who are five and older Higher scores reflect greater age-expected participation The CASP has reported evidence of test re-test reliability Intraclass Correlation Coefficient 094 internal consistency α 096 and construct and discriminant validity
The Pediatric Quality of Life Inventory PedsQL - We used Version 40 the childs report which profiles childrens 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 A higher order dimension of the Psychosocial Health dimension encompasses emotional and social functioning The child marks the frequency of problems which occurred in the past one month on a five-point response Likert scale 0 never a problem 1 almost never a problem 2 sometimes a problem 3 often a problem 4 almost always a problem Items are then transformed into a 0-100-point scale 0 100 1 75 2 50 3 25 4 0 to present the HRQoL percentage A higher percentage indicates a better HRQoL
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 parents will provide informed consent
References
1 Orsini A Corsi M Santangelo A et al Challenges and management of neurological and psychiatric manifestations in SARS-CoV-2 COVID-19 patients Neurol Sci 41 2353-2366 2020 httpsdoiorg101007s10072-020-04544-
2 Rahman J Muralidharan A Quazi S J et al June 05 2020 Neurological and Psychological Effects of Coronavirus COVID-19 An Overview of the Current Era Pandemic Cureus 126 e8460 DOI 107759cureus8460
3 Ellul MA Benjamin L Singh B Lant S Michael BD Easton A Kneen R Defres S Sejvar J Solomon T Neurological associations of COVID-19 Lancet Neurol 2020 Sep199767-783 doi 101016S1474-44222030221-0 Epub 2020 Jul 2 PMID 32622375 PMCID PMC7332267
4 Wang S Zhang Y Ding W Meng Y Hu H Liu Z Zeng X Wang M 2020 Psychological distress and sleep problems when people are under interpersonal isolation during an epidemic A nationwide multicenter cross-sectional study European Psychiatry 631 e77 1-8 httpsdoiorg101192jeurpsy202078
5 Chen K-Y Li T Gong F-H Zhang J-S and Li X-K 2020 Predictors of Health- Related Quality of Life and Influencing Factors for COVID-19 Patients a Follow-Up at One Month Front Psychiatry 11668 doi 103389fpsyt202000668
6 Wang Z Zhou Q Wang C et al Clinical characteristics of children with COVID-19 a rapid review and meta-analysis Ann Transl Med 2020810620 doi1021037atm-20-3302
7 Abdel-Mannan O Eyre M Löbel U et al Neurologic and Radiographic Findings Associated With COVID-19 Infection in Children JAMA Neurol Published online July 01 2020 doi101001jamaneurol20202687
8 Xie X Xue Q Zhou Y et al Mental Health Status Among Children in Home Confinement During the Coronavirus Disease 2019 Outbreak in Hubei Province China published online ahead of print 2020 Apr 24 JAMA Pediatr 2020e201619 doi101001jamapediatrics20201619
9 Zhou SJ Zhang LG Wang LL Guo ZC Wang JQ Chen JC Liu M Chen X Chen JX Prevalence and socio-demographic correlates of psychological health problems in Chinese adolescents during the outbreak of COVID-19 Eur Child Adolesc Psychiatry 2020 Jun296749-758 doi 101007s00787-020-01541-4 Epub 2020 May 3 PMID 32363492 PMCID PMC7196181
10 Jiao WY Wang LN Liu J et al Behavioral and Emotional Disorders in Children during the COVID-19 Epidemic J Pediatr 2020221264-266e1 doi101016jjpeds202003013
11 Ping W Zheng J Niu X Guo C Zhang J Yang H et al 2020 Evaluation of health-related quality of life using EQ-5D in China during the COVID-19 pandemic PLoS ONE 156 e0234850 httpsdoiorg101371journalpone0234850
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 pandemics 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
Our hypotheses were that 1 children with migraine would have significantly lower EF higher anxiety lower participation and QOL than healthy controls 2 When comparing children affected by COVID-19 those who were not affected by COVID-19 withing and between groups children with migraine who were affected by COVID-19 would have the lowest EF highest anxiety lowest participation and QOL 3 Among children with migraine significant correlations would be found between migraine severity Ped MIDAS EF anxiety participation and QOL 4 EF anxiety migraine severity and participation would significantly predict QOL
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
For the study group only
Medical Assessment A prospective medical history including a thorough headache history and physical and neurological assessment by a pediatric neurologist were done in all children during the visit at the pediatric neurology clinic All children met the diagnostic criteria for migraine according to the International Classification of Headache Disorders 3rd edition ICHD-3
PedMIDAS Headache related disability was evaluated by the PedMIDAS questionnaire It was developed to assess migraine disability in pediatric and adolescent patients and has been tested and validated for ages 4 to 18
For all participants
Health status questionnaire- A thorough questionnaire about the general health of all participants including information about COVID-19 - as whether the child was infected by the virus
Behavior Rating Inventory of Executive Functions BRIEF - The BRIEF is a behavioral rating measure for children and youth aged 5-18 years that aims to measure the childs EF as expressed in daily life situations for example becomes upset with new situations has a messy desk disturbed by change of teacher or class does not check work for mistakes has trouble concentrating on chores schoolwork In the present study we used the BRIEF parents report The BRIEF includes 86 items that measure various EF and are summarized into two scales Behavioral Regulation Index BRI which includes the inhibition shifting and emotional control scales and the Metacognition Index MI which includes the initiation working memory planning organization of materials and monitoring scales The Global Executive Composite GEC total score is generated from both BRI and MI scores Parents rate how frequent the child express the behavior described in each BRIEF item on a Likert scale that ranges from 1 infrequently to 3 often All row scores are converted to a standard scores A total cut-off standard score of 65 indicates deficiencies in executive functions As higher is the scores the worse are the EF The BRIEF has good psychometric properties Gioia et al 2015 Gioia Isquith Guy Kenworthy 2000 McGill Snow 2021
The State-Trait Anxiety Inventory for Children STAIC Spielberger C D Edwards C D Montouri J Lushene R 1973 distinguishes between a general proneness to anxious behavior rooted in the personality and anxiety as a fleeting emotional state The STAIC S-Anxiety scale consists of twenty statements that ask children how they feel at a particular moment in time The STAIC T-Anxiety scale also consists of 20 item statements but subjects respond to these items by indicating how they generally feel The instrument is designed to be used with upper elementary or junior high school aged children Higher mean score represents lower anxiety
The Child and Adolescent Scale of Participation CASP Bedell 2011 - measures the extent to which children participate in home school and community activities compared to children of the same age as reported by family caregivers The content and methods used in the CASP and CFFS were informed by the International Classification of Functioning ICF WHO 2001 research addressing participation of children youth with a range of disabilities and factors related to the child family and physical and social environment that support and or hinder participation The CASP consists of 20 ordinal-scaled items and four subsections 1 Home Participation 6 items 2 Community Participation 4 items 3 School Participation 5 items and 4 Home and Community Living Activities 5 items The 20 items are rated on a four-point scale Age Expected Full participation Somewhat Restricted Very Restricted Unable A Not Applicable response is selected when the item reflects an activity in which the child would not be expected to participate due to age eg work Most items are applicable to children who are five and older Higher scores reflect greater age-expected participation The CASP has reported evidence of test re-test reliability Intraclass Correlation Coefficient 094 internal consistency α 096 and construct and discriminant validity
The Pediatric Quality of Life Inventory PedsQL - We used Version 40 the childs report which profiles childrens 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 A higher order dimension of the Psychosocial Health dimension encompasses emotional and social functioning The child marks the frequency of problems which occurred in the past one month on a five-point response Likert scale 0 never a problem 1 almost never a problem 2 sometimes a problem 3 often a problem 4 almost always a problem Items are then transformed into a 0-100-point scale 0 100 1 75 2 50 3 25 4 0 to present the HRQoL percentage A higher percentage indicates a better HRQoL
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 parents will provide informed consent
References
1 Orsini A Corsi M Santangelo A et al Challenges and management of neurological and psychiatric manifestations in SARS-CoV-2 COVID-19 patients Neurol Sci 41 2353-2366 2020 httpsdoiorg101007s10072-020-04544-
2 Rahman J Muralidharan A Quazi S J et al June 05 2020 Neurological and Psychological Effects of Coronavirus COVID-19 An Overview of the Current Era Pandemic Cureus 126 e8460 DOI 107759cureus8460
3 Ellul MA Benjamin L Singh B Lant S Michael BD Easton A Kneen R Defres S Sejvar J Solomon T Neurological associations of COVID-19 Lancet Neurol 2020 Sep199767-783 doi 101016S1474-44222030221-0 Epub 2020 Jul 2 PMID 32622375 PMCID PMC7332267
4 Wang S Zhang Y Ding W Meng Y Hu H Liu Z Zeng X Wang M 2020 Psychological distress and sleep problems when people are under interpersonal isolation during an epidemic A nationwide multicenter cross-sectional study European Psychiatry 631 e77 1-8 httpsdoiorg101192jeurpsy202078
5 Chen K-Y Li T Gong F-H Zhang J-S and Li X-K 2020 Predictors of Health- Related Quality of Life and Influencing Factors for COVID-19 Patients a Follow-Up at One Month Front Psychiatry 11668 doi 103389fpsyt202000668
6 Wang Z Zhou Q Wang C et al Clinical characteristics of children with COVID-19 a rapid review and meta-analysis Ann Transl Med 2020810620 doi1021037atm-20-3302
7 Abdel-Mannan O Eyre M Löbel U et al Neurologic and Radiographic Findings Associated With COVID-19 Infection in Children JAMA Neurol Published online July 01 2020 doi101001jamaneurol20202687
8 Xie X Xue Q Zhou Y et al Mental Health Status Among Children in Home Confinement During the Coronavirus Disease 2019 Outbreak in Hubei Province China published online ahead of print 2020 Apr 24 JAMA Pediatr 2020e201619 doi101001jamapediatrics20201619
9 Zhou SJ Zhang LG Wang LL Guo ZC Wang JQ Chen JC Liu M Chen X Chen JX Prevalence and socio-demographic correlates of psychological health problems in Chinese adolescents during the outbreak of COVID-19 Eur Child Adolesc Psychiatry 2020 Jun296749-758 doi 101007s00787-020-01541-4 Epub 2020 May 3 PMID 32363492 PMCID PMC7196181
10 Jiao WY Wang LN Liu J et al Behavioral and Emotional Disorders in Children during the COVID-19 Epidemic J Pediatr 2020221264-266e1 doi101016jjpeds202003013
11 Ping W Zheng J Niu X Guo C Zhang J Yang H et al 2020 Evaluation of health-related quality of life using EQ-5D in China during the COVID-19 pandemic PLoS ONE 156 e0234850 httpsdoiorg101371journalpone0234850
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None