Children's Attitude Towards Helmet Use in Traffic.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Erasmus Medical Center
- Enrollment
- 280
- Primary Endpoint
- Helmet use prevalence using a questionnaire
Study Overview
Brief 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.
Detailed Description
This will be a case-control study consisting of two groups.
Hospital procedure Pediatric patients between 6 and 18 years old with a presentation at the ED of the Erasmus MC in Rotterdam after a bicycle accident between January 2017 and June 2024 will be registered into a database.
The researchers will contact these patients and ask them whether they're interested to participate in this study. The period of time between their accident and participation into the study must be at least 3 months.Patients that are interested will receive a letter at home containing detailed information about the study and a consent form. These patients have 4 weeks to carefully read everything and return the completed consent form by post. After this, a short, non-invasive questionnaire about helmet use and attitude towards helmet use will be administered.
Children aged 6 to 12 years will be be interviewed through a video call. In accordance with their parents/caregivers/representatives, an appointment will be scheduled to do this.Children aged 12 years and older will be asked to fill out an online questionnaire in their free time. They will receive it by email and so they can fill it out via their mobile phone, computer, tablet, etc. It takes around 10 minutes to fill out the questionnaire.
Information regarding the period of time between the visit to the ED and participation in the study; and injuries caused by the accident, as mentioned in other study parameter (8.1.3), will be collected from the electronic patient records (HIX).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded from participation in this study:
- •A non-bicycle accident (e.g. pedestrian, scooter, car)
- •Being a bicycle passenger
- •Linguistic barrier (unable to answer questions in Dutch or English)
- •Exclusion criteria for the control group:
- •Presentation to any emergency department after a bicycle accident in the past.
- •Being a bicycle passenger
- •Linguistic barrier (unable to answer questions in Dutch or English)
Outcomes
Primary Outcomes
Helmet use prevalence using a questionnaire
Time Frame: 6 months
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 Outcomes
- Helmet use attitude using a questionnaire(6 months)
Investigators
Dr. Antoinette V. J. Rozeboom
Principal Investigator
Erasmus Medical Center