Children's Attitude Towards Helmet Use in Traffic.

NCT06490042 | Not Yet Recruiting

• 1 other identifier: 12187
• Study Type: observational
• Target: 280
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Helmets; Children; Behavior And Behavior Mechanism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Helmet use attitude using a questionnaire

  6 months

Other Outcomes (2)

• Association between period of time post accident and attitude using a questionnaire and electronic patient files (EPF)

  6 months

• Association between type of injury and attitude using a questionnaire and EPF

  6 months

Study Arms (2)

study group

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.

Behavioral: Questionnaire

control group

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.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

A questionnaire about helmet use and attitude towards helmet use.

control group; study group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Gender Eligibility Details: participants will be asked what their biological gender is.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• To be eligible for participation in this study, a patient must meet all of the following criteria:
• Presentation at the ED of the Erasmus MC in Rotterdam between January 2017 and June 2024 after a bicycle accident.
• Informed consent is obtained
• A maximum score on the Glasgow Coma Scale at the time the questionnaire is administered.
• Time between accident and questionnaire is at least 3 months
• Informed consent is obtained
• Using a bicycle

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Erasmus Medical Center: lead

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Antoinette V.J. Rozeboom, Dr. M.D.

CONTACT

0031624984936; a.rozeboom@erasmusmc.nl

Naoufal Bourimi, Bsc

CONTACT

0628388980; n.bourimi@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: July 8, 2024
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share