Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490042
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-15
Brief Title:
Childrens Attitude Towards Helmet Use in Traffic
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Childrens Attitude Towards Helmet Use in Traffic
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ChildHELMED
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 childrens 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 parametersendpoints
The main study parameter is helmet use
Secondary study parametersendpoints
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
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 childrens 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 parametersendpoints
The main study parameter is helmet use
Secondary study parametersendpoints
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 theyre interested to participate in this study The period of time between their accident and participation into the study must be at least 3 monthsPatients 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 parentscaregiversrepresentatives an appointment will be scheduled to do thisChildren 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 813 will be collected from the electronic patient records HIX
School procedure To create a representative control group potential participants are being selected based on the age and place of residence of the paediatric patients
Therefore the researchers will contact primary and secondary schools and ask them whether theyre interested to participate in this study Schools that are interested will receive letters that the teachers can hand out to their students These letters contain detailed information about the study and a consent form These letters can only be given to students older than 6 years and younger than 18 years Students have 4 weeks to carefully read everything an return a completed consent form to their teachers if they want to participate After these weeks the researchers will visit the schools to collect the consent forms After this a short non-invasive questionnaire about helmet use and attitude towards helmet use will be administered
In case of primary school children will be interviewed by the researchers In accordance with the school and their teachers an appointment will be scheduled to do this In case of secondary schools children 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
Reminder All participants who are asked to fill out an online questionnaire in their free time will receive an online reminder via email in case they did not fill out their questionnaire after one month
Informed consent procedures For children aged 6-12 years informed consent must be obtained from their parents caregiversrepresentatives For children aged 12-16 years informed consent must be obtained from both the parentscaregiversrepresentatives and the participants themselves Children older than 16 can provide consent on their own When informed consent is obtained all participant will receive a copy at home
Questionnaire To investigate attitude towards helmet use a questionnaire is created based on the Health Belief Model HBM This model is widely used in research to investigate participants behavior 3536 This model defines the key factors that influence health behaviors as an individuals perceived threat to sickness or disease perceived susceptibility belief of consequences perceived severity potential positive benefits of action perceived benefits perceived barriers to action exposure to factors that prompt action cues to action 37
Perceived Susceptibility consists of 2 subscales The first subscale is named Perceived Exemption from Harm and consists of 9 statements Higher scores on these statements indicate more agreement with reasons for not needing a bicycle helmet in traffic The second subscale is named Perceived Danger of Cycling and consists of 6 statements Higher scores on these statements indicate more agreement with the perception that cycling can be dangerous
Perceived Severity of Harm consists of 6 statements Increased scores indicate a greater understanding of the potential severity of consequences associated with bicycling injury
Perceived Benefits consists of 2 subscales Emotional Benefits is the first one and consists of 5 statements Higher scores reflect more agreement regarding the positive impact of helmet use on ones emotional status Safety Benefits is the second subscale and consists of 4 statements Higher scores suggest a stronger agreement that helmets can protect people against harm in a bicycle accident
Perceived Barriers consist of 2 subscales The first one is named Personal Vanity and Discomfort Barriers and consists of 10 statements Higher scores indicate agreement with the idea that helmets are unattractive and uncomfortable The second subscale is named Cost Barriers Higher scores on these 5 statements indicate economic factors contributing to the decision to not wear a helmet
Cues To Action consists of 5 subscales The first one is named social circle Higher scores on these 4 statements reflect a stronger agreement that participants receive support from friends and family to wear a helmet The second subscale is Past Events Higher scores on these 3 statements indicate that past bicycle accident related events influence helmet use The third one is named Accessibility Higher scores on these 3 statements suggest that a helmet is easily accessible The fourth subscale is named Rules at Home and consists of 2 statements Higher scores reflect agreement that parentscaregiversrepresentatives have or had rules about helmet use The fifth subscale is named Rules at School and consists of 3 statements Higher scores reflect agreement that their school focuses on traffic safety and helmet useThe last one is named Media Higher scores on these 5 statements suggest that people receive information on bicycle helmets from various media sources
Within the context of helmet use among cyclists these elements may explain why some children choose to use a bicycle helmet while others do not
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 theyre interested to participate in this study The period of time between their accident and participation into the study must be at least 3 monthsPatients 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 parentscaregiversrepresentatives an appointment will be scheduled to do thisChildren 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 813 will be collected from the electronic patient records HIX
School procedure To create a representative control group potential participants are being selected based on the age and place of residence of the paediatric patients
Therefore the researchers will contact primary and secondary schools and ask them whether theyre interested to participate in this study Schools that are interested will receive letters that the teachers can hand out to their students These letters contain detailed information about the study and a consent form These letters can only be given to students older than 6 years and younger than 18 years Students have 4 weeks to carefully read everything an return a completed consent form to their teachers if they want to participate After these weeks the researchers will visit the schools to collect the consent forms After this a short non-invasive questionnaire about helmet use and attitude towards helmet use will be administered
In case of primary school children will be interviewed by the researchers In accordance with the school and their teachers an appointment will be scheduled to do this In case of secondary schools children 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
Reminder All participants who are asked to fill out an online questionnaire in their free time will receive an online reminder via email in case they did not fill out their questionnaire after one month
Informed consent procedures For children aged 6-12 years informed consent must be obtained from their parents caregiversrepresentatives For children aged 12-16 years informed consent must be obtained from both the parentscaregiversrepresentatives and the participants themselves Children older than 16 can provide consent on their own When informed consent is obtained all participant will receive a copy at home
Questionnaire To investigate attitude towards helmet use a questionnaire is created based on the Health Belief Model HBM This model is widely used in research to investigate participants behavior 3536 This model defines the key factors that influence health behaviors as an individuals perceived threat to sickness or disease perceived susceptibility belief of consequences perceived severity potential positive benefits of action perceived benefits perceived barriers to action exposure to factors that prompt action cues to action 37
Perceived Susceptibility consists of 2 subscales The first subscale is named Perceived Exemption from Harm and consists of 9 statements Higher scores on these statements indicate more agreement with reasons for not needing a bicycle helmet in traffic The second subscale is named Perceived Danger of Cycling and consists of 6 statements Higher scores on these statements indicate more agreement with the perception that cycling can be dangerous
Perceived Severity of Harm consists of 6 statements Increased scores indicate a greater understanding of the potential severity of consequences associated with bicycling injury
Perceived Benefits consists of 2 subscales Emotional Benefits is the first one and consists of 5 statements Higher scores reflect more agreement regarding the positive impact of helmet use on ones emotional status Safety Benefits is the second subscale and consists of 4 statements Higher scores suggest a stronger agreement that helmets can protect people against harm in a bicycle accident
Perceived Barriers consist of 2 subscales The first one is named Personal Vanity and Discomfort Barriers and consists of 10 statements Higher scores indicate agreement with the idea that helmets are unattractive and uncomfortable The second subscale is named Cost Barriers Higher scores on these 5 statements indicate economic factors contributing to the decision to not wear a helmet
Cues To Action consists of 5 subscales The first one is named social circle Higher scores on these 4 statements reflect a stronger agreement that participants receive support from friends and family to wear a helmet The second subscale is Past Events Higher scores on these 3 statements indicate that past bicycle accident related events influence helmet use The third one is named Accessibility Higher scores on these 3 statements suggest that a helmet is easily accessible The fourth subscale is named Rules at Home and consists of 2 statements Higher scores reflect agreement that parentscaregiversrepresentatives have or had rules about helmet use The fifth subscale is named Rules at School and consists of 3 statements Higher scores reflect agreement that their school focuses on traffic safety and helmet useThe last one is named Media Higher scores on these 5 statements suggest that people receive information on bicycle helmets from various media sources
Within the context of helmet use among cyclists these elements may explain why some children choose to use a bicycle helmet while others do not
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None