The Incidents of Weekend Headaches in Children

January 30, 2022 updated by: Jacob.genizi, Bnai Zion Medical Center

Weekend Headaches in School-age Children

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel
        • Recruiting
        • Bani Zion
        • Contact:
          • Jacob Genizi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

children age 6-18 years old with normal development attending scool

Description

Inclusion Criteria:

  • Children age 6-18 years old with primary headaches
  • Attending school

Exclusion Criteria:

  • Secondary headaches
  • Developmental delay
  • Malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weekends headaches frequency
Time Frame: 1 year
Are weekdays headaches frequent in school children more than in weekends? We will use a pen headache diary to asses headache frequency
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weekends headaches frequency risk factors
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Investigators

  • Principal Investigator: jacob Genizi, MD, Bnai Zion Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

January 30, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 30, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bnz 0138-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Headache

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe