Migraine DisordersNCT06077006
The Impact of nCoV-2019 on Children With Migraine
An observational study of Migraine Disorders and COVID-19 Pandemic, run by Bnai Zion Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine Disorders, COVID-19 Pandemic
- What is being tested?
- questionnaires Only
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2021to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Child
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 Migraine, headache or other chronic diseases, assessed during routine visits at the Pediatric Neurology Clinic or for other reasons, will also be included.
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.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Executive Functions, Anxiety and Their Relation to Social Participation and Quality of Life Among Children With Migraine During COVID-19
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.
Read more
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
Read the 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:
- 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). https://doi.org/10.1007/s10072-020-04544-
- 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 12(6): e8460. DOI 10.7759/cureus.8460
- 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 Sep;19(9):767-783. doi: 10.1016/S1474-4422(20)30221-0. Epub 2020 Jul 2. PMID: 32622375; PMCID: PMC7332267.
- 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, 63(1), e77, 1-8 https://doi.org/10.1192/j.eurpsy.2020.78
- 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 11:668. doi: 10.3389/fpsyt.2020.00668
- Wang Z, Zhou Q, Wang C, et al. Clinical characteristics of children with COVID-19: a rapid review and meta-analysis. Ann Transl Med. 2020;8(10):620. doi:10.21037/atm-20-3302
- 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. doi:10.1001/jamaneurol.2020.2687
- 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. 2020;e201619. doi:10.1001/jamapediatrics.2020.1619
- 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 Jun;29(6):749-758. doi: 10.1007/s00787-020-01541-4. Epub 2020 May 3. PMID: 32363492; PMCID: PMC7196181.
- Jiao WY, Wang LN, Liu J, et al. Behavioral and Emotional Disorders in Children during the COVID-19 Epidemic. J Pediatr. 2020;221:264-266.e1. doi:10.1016/j.jpeds.2020.03.013
- 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 15(6): e0234850. https://doi.org/10.1371/journal.pone.0234850.
- Conditions
- Migraine Disorders, COVID-19 Pandemic
- Being tested
- questionnaires Only
- Medical subject headings
- Migraine Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires OnlyOther
questionnaires Only
| Study group | Role | What they receive |
|---|---|---|
| Research | 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. Receives: Other: questionnaires Only | |
| Control | Children without Migraine, headache or other chronic diseases Receives: Other: questionnaires Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Rating Inventory of Executive Functions (BRIEF)
Executive Functions as expressed in daily life situations among migraine group is worse compared to the control.
Measured: 12 months
The Pediatric Quality of Life Inventory (PedsQL(
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Apr 2021
- Primary completion30 Apr 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jacob.genizi, Bnai Zion Medical Center
- Investigators
- jacob Genizi, MD, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077006
- Sponsor's protocol ID
- 185-20 BNZ
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All personal Data is classified.
Publications
Orsini A, Corsi M, Santangelo A, Riva A, Peroni D, Foiadelli T, Savasta S, Striano P. Challenges and management of neurological and psychiatric manifestations in SARS-CoV-2 (COVID-19) patients. Neurol Sci. 2020 Sep;41(9):2353-2366. doi: 10.1007/s10072-020-04544-w. Epub 2020 Aug 6.
PubMed 32767055Rahman J, Muralidharan A, Quazi SJ, Saleem H, Khan S. Neurological and Psychological Effects of Coronavirus (COVID-19): An Overview of the Current Era Pandemic. Cureus. 2020 Jun 5;12(6):e8460. doi: 10.7759/cureus.8460.
PubMed 32528783Ellul 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 Sep;19(9):767-783. doi: 10.1016/S1474-4422(20)30221-0. Epub 2020 Jul 2.
PubMed 32622375Wang S, Zhang Y, Ding W, Meng Y, Hu H, Liu Z, Zeng X, Wang M. Psychological distress and sleep problems when people are under interpersonal isolation during an epidemic: A nationwide multicenter cross-sectional study. Eur Psychiatry. 2020 Aug 28;63(1):e77. doi: 10.1192/j.eurpsy.2020.78.
PubMed 32854786Chen KY, Li T, Gong FH, Zhang JS, Li XK. Predictors of Health-Related Quality of Life and Influencing Factors for COVID-19 Patients, a Follow-Up at One Month. Front Psychiatry. 2020 Jul 8;11:668. doi: 10.3389/fpsyt.2020.00668. eCollection 2020.
PubMed 32733299Wang Z, Zhou Q, Wang C, Shi Q, Lu S, Ma Y, Luo X, Xun Y, Li W, Baskota M, Yang Y, Zhai H, Fukuoka T, Ahn HS, Lee MS, Luo Z, Liu E, Chen Y; COVID-19 Evidence and Recommendations Working Group. Clinical characteristics of children with COVID-19: a rapid review and meta-analysis. Ann Transl Med. 2020 May;8(10):620. doi: 10.21037/atm-20-3302.
PubMed 32566557Abdel-Mannan O, Eyre M, Lobel U, Bamford A, Eltze C, Hameed B, Hemingway C, Hacohen Y. Neurologic and Radiographic Findings Associated With COVID-19 Infection in Children. JAMA Neurol. 2020 Nov 1;77(11):1440-1445. doi: 10.1001/jamaneurol.2020.2687.
PubMed 32609336Zhou 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 Jun;29(6):749-758. doi: 10.1007/s00787-020-01541-4. Epub 2020 May 3.
PubMed 32363492Ping W, Zheng J, Niu X, Guo C, Zhang J, Yang H, Shi Y. Evaluation of health-related quality of life using EQ-5D in China during the COVID-19 pandemic. PLoS One. 2020 Jun 18;15(6):e0234850. doi: 10.1371/journal.pone.0234850. eCollection 2020.
PubMed 32555642
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Functions, Anxiety and Their Relation to Social Participation and Quality of Life Among Children With Migraine During COVID-19
- ClinicalTrials.gov ID
- NCT06077006
- Acronym / sponsor ID
- 185-20 BNZ
- Conditions
- Migraine Disorders, COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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). https://doi.org/10.1007/s10072-020-04544-
- 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 12(6): e8460. DOI 10.7759/cureus.8460
- 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 Sep;19(9):767-783. doi: 10.1016/S1474-4422(20)30221-0. Epub 2020 Jul 2. PMID: 32622375; PMCID: PMC7332267.
- 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, 63(1), e77, 1-8 https://doi.org/10.1192/j.eurpsy.2020.78
- 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 11:668. doi: 10.3389/fpsyt.2020.00668
- Wang Z, Zhou Q, Wang C, et al. Clinical characteristics of children with COVID-19: a rapid review and meta-analysis. Ann Transl Med. 2020;8(10):620. doi:10.21037/atm-20-3302
- 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. doi:10.1001/jamaneurol.2020.2687
- 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. 2020;e201619. doi:10.1001/jamapediatrics.2020.1619
- 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 Jun;29(6):749-758. doi: 10.1007/s00787-020-01541-4. Epub 2020 May 3. PMID: 32363492; PMCID: PMC7196181.
- Jiao WY, Wang LN, Liu J, et al. Behavioral and Emotional Disorders in Children during the COVID-19 Epidemic. J Pediatr. 2020;221:264-266.e1. doi:10.1016/j.jpeds.2020.03.013
- 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 15(6): e0234850. https://doi.org/10.1371/journal.pone.0234850.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research | – | Other: questionnaires OnlyChildren between the ages of 6 and 18 years, diagnosed with Migraine, who are under follow-up at the Pediatric Neurology Clinic in Bnei Zion. |
| Control | – | Other: questionnaires OnlyChildren without Migraine, headache or other chronic diseases |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Age groups
- Child
- 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 Migraine, headache or other chronic diseases, assessed during routine visits at the Pediatric Neurology Clinic or for other reasons, will also be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaires Onlyquestionnaires Only | Other | Control, Research |
Primary outcome
Behavior Rating Inventory of Executive Functions (BRIEF)
Time frame: 12 months
Executive Functions as expressed in daily life situations among migraine group is worse compared to the control.
The Pediatric Quality of Life Inventory (PedsQL(
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Results publication: PubMed 32767055Orsini A, Corsi M, Santangelo A, Riva A, Peroni D, Foiadelli T, Savasta S, Striano P. Challenges and management of neurological and psychiatric manifestations in SARS-CoV-2 (COVID-19) patients. Neurol Sci. 2020 Sep;41(9):2353-2366. doi: 10.1007/s10072-020-04544-w. Epub 2020 Aug 6.
- Results publication: PubMed 32528783Rahman J, Muralidharan A, Quazi SJ, Saleem H, Khan S. Neurological and Psychological Effects of Coronavirus (COVID-19): An Overview of the Current Era Pandemic. Cureus. 2020 Jun 5;12(6):e8460. doi: 10.7759/cureus.8460.
- Results publication: PubMed 32622375Ellul 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 Sep;19(9):767-783. doi: 10.1016/S1474-4422(20)30221-0. Epub 2020 Jul 2.
- Results publication: PubMed 32854786Wang S, Zhang Y, Ding W, Meng Y, Hu H, Liu Z, Zeng X, Wang M. Psychological distress and sleep problems when people are under interpersonal isolation during an epidemic: A nationwide multicenter cross-sectional study. Eur Psychiatry. 2020 Aug 28;63(1):e77. doi: 10.1192/j.eurpsy.2020.78.
- Results publication: PubMed 32733299Chen KY, Li T, Gong FH, Zhang JS, Li XK. Predictors of Health-Related Quality of Life and Influencing Factors for COVID-19 Patients, a Follow-Up at One Month. Front Psychiatry. 2020 Jul 8;11:668. doi: 10.3389/fpsyt.2020.00668. eCollection 2020.
- Results publication: PubMed 32566557Wang Z, Zhou Q, Wang C, Shi Q, Lu S, Ma Y, Luo X, Xun Y, Li W, Baskota M, Yang Y, Zhai H, Fukuoka T, Ahn HS, Lee MS, Luo Z, Liu E, Chen Y; COVID-19 Evidence and Recommendations Working Group. Clinical characteristics of children with COVID-19: a rapid review and meta-analysis. Ann Transl Med. 2020 May;8(10):620. doi: 10.21037/atm-20-3302.
- Results publication: PubMed 32609336Abdel-Mannan O, Eyre M, Lobel U, Bamford A, Eltze C, Hameed B, Hemingway C, Hacohen Y. Neurologic and Radiographic Findings Associated With COVID-19 Infection in Children. JAMA Neurol. 2020 Nov 1;77(11):1440-1445. doi: 10.1001/jamaneurol.2020.2687.
- Results publication: PubMed 32363492Zhou 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 Jun;29(6):749-758. doi: 10.1007/s00787-020-01541-4. Epub 2020 May 3.
- Results publication: PubMed 32555642Ping W, Zheng J, Niu X, Guo C, Zhang J, Yang H, Shi Y. Evaluation of health-related quality of life using EQ-5D in China during the COVID-19 pandemic. PLoS One. 2020 Jun 18;15(6):e0234850. doi: 10.1371/journal.pone.0234850. eCollection 2020.
- Individual participant dataSharing planned: No. All personal Data is classified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jacob Genizi, MD principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders and COVID-19 Pandemic, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Rating Inventory of Executive Functions (BRIEF) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06077006, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.