NCT06077006

The Impact of nCoV-2019 on Children With Migraine

Completed Last updated 11 October 2023

What this trial tests

trial testing questionnaires Only in Migraine Disorders in 150 participants. Completed in 30 July 2023.

Timeline

1 April 2021

Primary endpoint
30 April 2023

30 July 2023

Quick facts

Lead sponsor	Bnai Zion Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	150
Start date	1 April 2021
Primary completion	30 April 2023
Estimated completion	30 July 2023
Sites	1 location across Israel

Drugs / interventions tested

• questionnaires Only

Conditions studied

• Migraine Disorders — all drugs for Migraine Disorders →
• COVID-19 Pandemic — all drugs for COVID-19 Pandemic →

Sponsor

Bnai Zion Medical Center

Who can join

Adults 6 to 17, any sex, with Migraine Disorders or COVID-19 Pandemic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Executive Functions, Anxiety, Social Participation and Quality of Life in Children with Migraine During COVID-19.
   Genizi J, Samet H, Zaitoon H, Elimelech U, et al · · 2025 · cited 1× · PMID 40283083 · DOI 10.3390/life15040528