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Children's Attitude Towards Helmet Use in Traffic.

Study acronym: ChildHELMED
StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 4, 2024 (before its estimated January 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Start date: Jul 1, 2024 to Oct 1, 2024 Primary completion date: Oct 1, 2024 to Jan 1, 2025 · Completion date: Jan 1, 2025 to Jun 1, 2025v2 Show 2 more changesShow less
    • Primary completion date: Oct 1, 2024 to Jan 1, 2025
    • Completion date: Jan 1, 2025 to Jun 1, 2025
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06490042
Lead Sponsor Erasmus Medical Center
Conditions Helmets, Children, Behavior And Behavior Mechanism
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov