Children's Attitude Towards Helmet Use in Traffic.
NCT Number: NCT06490042
Acronym: ChildHELMED
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Helmets|Children|Behavior And Behavior Mechanism
Interventions: BEHAVIORAL: Questionnaire
Sponsor: Erasmus Medical Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 280
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-06-01

Summary:
SUMMARY

Rationale:

Literature shows that helmet use is essential in the prevention of severe head injuries among children involved in bicycle accidents. However, helmet use in children remains low. Therefore, it is relevant to investigate the reason why helmet use among children is still low. In addition, it is unclear whether experiencing a serious bicycle accident influences helmet use and attitude towards helmet use among children.

Objectives:

Primary objective:

The aim of this study is to investigate the number of children using a bicycle helmet after visiting the emergency department (ED) following a bicycle accident compared to children who have not.

Secondary objective:

The secondary objective is to investigate children's attitude towards helmet use after visiting the ED following a bicycle accident compared to children who have not.

Other objectives:

To investigate the association between period of time after visiting the ED and attitude towards helmet use.

To investigate the association between type of injuries and attitude towards helmet use.

Study design: case control study

Study population:

The study group consists of children between 6 and 18 years presenting at the ED of the Erasmus Medical Centre (Erasmus MC) in Rotterdam after a bicycle accident between January 2017 and June 2024.

The control group consists of children between 6 and 18 years in primary and secondary schools without a presentation at a ED after a bicycle accident in the past.

Intervention:

A questionnaire about helmet use and attitude towards helmet use.

Main study parameters/endpoints:

The main study parameter is helmet use.

Secondary study parameters/endpoints:

The secondary parameter is attitude towards helmet use.

Nature and extent of the burden and risks associated with participation, benefit, and group relatedness:

A short, questionnaire will be administered. It takes around 10 minutes. There are no invasive interventions and thereby the risk and burden associated with participation in this study is considered low.

Primary Outcome Measures: Helmet use prevalence using a questionnaire, The number of children using a bicycle helmet after visiting the emergency department (ED) following a bicycle accident compared to children who have not., 6 months
Secondary Outcome Measures: Helmet use attitude using a questionnaire, Children's attitude towards helmet use after visiting the ED following a bicycle accident compared to children who have not., 6 months
Other Outcome Measures: Association between period of time post accident and attitude using a questionnaire and electronic patient files (EPF), The association between period of time after visiting the ED and attitude towards helmet use., 6 months|Association between type of injury and attitude using a questionnaire and EPF, The association between type of injuries and attitude towards helmet use., 6 months