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

Executive functions, anxiety and their relation to social participation and quality oflife among children with Migraine during COVID-19Backgrounds: Among children, especially adolescents, migraine stands out as one of themost prevalent headache disorders. It is susceptible to stress and has the potential toaffect 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 andquality of life (QoL) between children with migraine and healthy controls, and to examinethe differences of these factors between children who were infected by COVID-19 and thosewho were not.Study Population:The research will include 75 children between the ages of 6 and 18 years, diagnosed withMigraine, who are under follow-up at the Pediatric Neurology Clinic in Bnei Zion. Acontrol group of 75 children without chronic diseases, assessed during routine visits atthe Pediatric Neurology Clinic or for other reasons, will also be included.Research Methods:Participants will complete questionnaires related to demographic details, quality oflife, 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 secondaryheadaches or other chronic illness.Informed Consent:Participants aged 11 and older will provide informed consent, while younger children willreceive 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 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:

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 child's
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 (e.g., 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 = 0.94), internal consistency (α ≥ 0.96) and construct and
discriminant validity.

The Pediatric Quality of Life Inventory (PedsQL( (++ ) - We used Version 4.0 the child's
report, which profiles 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). 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:

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Completed
Migraine Disorders
COVID-19 Pandemic

Other: questionnaires Only

questionnaires Only

Eligibility Criteria

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.

-

Eligibility Gender
All
Eligibility Age
Minimum: 6 Years ~ Maximum: 17 Years
Countries
Israel
Locations

Bnai Zion Medical Center
Haifa 294801, Israel

jacob Genizi, MD, Principal Investigator
Bnai Zion Medical Center

Bnai Zion Medical Center
NCT Number
MeSH Terms
Migraine Disorders
COVID-19