The Incidents of Weekend Headaches in Children

Sponsor
Bnai Zion Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05218330
Collaborator
(none)
100
1
23.9
4.2

Study Details

Study Description

Brief Summary

This is an observational prospective follow-up study. The study population will include 30 children aged 6-18 years who suffer from a primary headache and are treated at the Pediatric Neurology Clinic at Bnai Zion Hospital in Haifa, Israel.

After the adolescents or parents sign an informed consent to participate in the study, they will receive a headache diary (Appendix 1) which they will fill out for 4 weeks as recommended [15]. They will mark the day the headache appeared, its intensity, duration, and timing during the day. In addition, they will fill the various triggers offered (such as sleep hours, exercise time, screen hours, and a subjective sense of academic or emotional stress) on days with headache and on every weekend.

We will then divide the participants into two groups - those who suffer from a headache in the middle of the week only (MWH) and those who suffer from a headache at the weekend (WH), compare the demographic and clinical characteristics and we will try to understand the triggers of these two groups.

Patients will also be asked a questionnaire which will define whether they are having difficulty in school (Appendix 2) so that we can examine the distribution of headaches of this group during the week.

A physician who works on the research team will proactively verify that the questionnaire is filled out consistently and accurately. Additional data will be collected from the medical record.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Research topic:

    Weekend headaches in school-age children

    Scientific background:

    Headache is one of the most common complaints in children and adolescents. It is recognized as one of the top medical and neurologic contributors to the global burden of disease and is a leading cause of disability in adolescents and young adults [1].

    Recurrent severe headaches also are common in children. In the United States, approximately 20 percent of children aged 4 to 18 years report having had notable recurrent headaches in the past 12 months and the prevalence increases with age [2].

    The International Classification of Headache Disorders, 3rd edition (ICHD-3) provides detailed diagnostic criteria for primary headaches which include mainly migraine and tension-type headache [3].

    A diary in which the quality, location, severity, timing, precipitating and palliating factors, and associated features of the headache are recorded prospectively (not subject to recall error) may be a useful adjunct if the child is willing and able to complete daily [4].

    There are many triggers for headaches including academic or emotional stress, lack of sleep, or lack of exercise, multiple screen hours, untidy meals, change in consumption of caffein, alcohol or energy drinks, etc. It can be assumed that the presence of these triggers varies between weekends and routine days at school and thus affects the incidence of headache [5-8].

    There are few studies that investigated weekend headaches among the adult population [9-11], and only two studies which mentioned differences in headache between days of the week among school [12, 13]. Mehta [12] reported the rate of headaches in weekends to be 5.9% compared to 28.5% on monday, among children age 7-14 years of age. However they didn't report on the incidence of other weekdays headaches. On the other hand, Larsson et al [13] didn't find significant difference in headache incidence between weekdays and weekends, although the peak incidence was at the middle of at Thursday.

    Finally, learning disabilities and ADHD are more common in children and adolescents who suffer from primary headaches [14], and because much of the headache in children is attributed to school, it will be interesting to see the effect of this group on the distribution of headache throughout the week.

    Purpose of the study:

    Our goal is to investigate whether there is weekend headache in children and adolescents and what are the risk factors.

    Methods:

    This is an observational prospective follow-up study. The study population will include 30 children aged 6-18 years who suffer from a primary headache and are treated at the Pediatric Neurology Clinic at Bnai Zion Hospital in Haifa, Israel.

    After the adolescents or parents sign an informed consent to participate in the study, they will receive a headache diary (Appendix 1) which they will fill out for 4 weeks as recommended [15]. They will mark the day the headache appeared, its intensity, duration, and timing during the day. In addition, they will fill the various triggers offered (such as sleep hours, exercise time, screen hours, and a subjective sense of academic or emotional stress) on days with headache and on every weekend.

    We will then divide the participants into two groups - those who suffer from a headache in the middle of the week only (MWH) and those who suffer from a headache at the weekend (WH), compare the demographic and clinical characteristics and we will try to understand the triggers of these two groups.

    Patients will also be asked a questionnaire which will define whether they are having difficulty in school (Appendix 2) so that we can examine the distribution of headaches of this group during the week.

    A physician who works on the research team will proactively verify that the questionnaire is filled out consistently and accurately. Additional data will be collected from the medical record.

    The study will be conducted after receiving approval from the Institutional Helsinki Committee

    Statistical analysis:

    The data will be processed and analyzed using SPSS software. Two sample t-test will be performed for continuous variables, and X² for categorial data. Odds ratios with 95% confidence intervals will be computed, statistical significance is considered as p <0.05.

    Tables and graphs:

    Appendix 1- Headache diary (לצרף Appendix 2- Questionnaire to diagnose suspected difficulty in studies (לצרף? Table 1- Demographic characteristics of children with weekend headache and children without weekend headache Weekend headache (WH) Midweek headache (MWH) P value Number of children, no. (%) 10 (33) 20 (67) Age, years, mean Sex, % Boys Girls Ethnicity, % Jewish Arab Other

    Table 2- Clinical characteristics of children with weekend headache and children without weekend headache Weekend headache (WH) Midweek headache (MWH) P value Severity, mean Duration, hours, mean Timing during the day (morning/evening) Type of headache Migraine Tension type headache Mixed Other learning disabilities % Other somatic complaints %

    Table 3- Lifestyle and stress triggers over the weekend Weekend headache (WH) Midweek headache (MWH) P value Academic stress (1-5), mean Emotional stress (1-5), mean Hours of sleep at night, mean Sportive activity (1-5), mean Regular meals (1-5), mean Screen hours, mean

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Weekend Headaches in School-age Children
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. weekends headaches frequency [1 year]

      Are weekdays headaches frequent in school children more than in weekends? We will use a pen headache diary to asses headache frequency

    Secondary Outcome Measures

    1. weekends headaches frequency risk factors [1 year]

      To investigate the risk factors for pediatric weekends headaches. We will use a questionnaire to asses sleeping hours, sport, meals and other triggers.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Children age 6-18 years old with primary headaches

    • Attending school

    Exclusion Criteria:
    • Secondary headaches

    • Developmental delay

    • Malignancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bani Zion Haifa Israel

    Sponsors and Collaborators

    • Bnai Zion Medical Center

    Investigators

    • Principal Investigator: Jacob genizi, md, Bnai Zion Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jacob.genizi, Director Pediatric Departement, Bnai Zion Medical Center
    ClinicalTrials.gov Identifier:
    NCT05218330
    Other Study ID Numbers:
    • bnz 0138-21
    First Posted:
    Feb 1, 2022
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jacob.genizi, Director Pediatric Departement, Bnai Zion Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 1, 2022