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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03619473
Other study ID # Motorcycle Child Helmet Study
Secondary ID 6384400
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2018

Study information

Verified date August 2018
Source Universiti Putra Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main aim of this intervention study is to test the hypothesis if helmet initiative program will significantly increase helmet usage in primary school students. The secondary aim of this intervention is to evaluate the behavioral change in standard child safety helmet usage among the parent/adult riders. The study was conducted in 23 primary school in Selangor from 1st January 2016 to 31st December 2018 in three different phases.


Description:

In Malaysia, the road traffic plans estimated that the number of death on road traffics might increase almost 23% from 2014-2020 (Royal Police of Malaysia, 2017). The main road crash involved the motorcyclist and the main cause of death was due to the severe head injuries. Previous study in Malaysia had reported only 20% of proper helmet usage among the adult riders (Malaysian Institute of Road Safety Research, 2015). This highlights the need to transfer the knowledge to the parent/adult riders on the importance, proper usage and availability of the standard child safety helmet and hence increase the prevalence of standard helmet usage for the pillion riders especially for the children.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 31, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 12 Years
Eligibility Inclusion Criteria:

- primary school students from selected school

- aged 7 - 12 years old

- Travel to school by motorcycle.

- the adult rider able to speak/read Malay and English

Exclusion Criteria:

- Students who are travelling to school using mode of transport other than motorcycle.

- pre school students

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Standard motorcycle child safety helmet
Educational session followed by demonstration on proper helmet wearing how to differentiate non-standard and standard helmets how to keep motorcycle safe using ABCD concept importance of wearing bright clothes police summon for not wearing helmets live demo on poor performance of non-standard helmet giving away standard motorcycle child safety helmets oath taking by parents and children distribution and placement of VEM on parents' motorcycles

Locations

Country Name City State
Malaysia Primary Schools in Hulu Langat District Hulu Langat Selangor
Malaysia Primary Schools in Petaling Perdana District Shah Alam Selangor

Sponsors (3)

Lead Sponsor Collaborator
Universiti Putra Malaysia Halliburton Foundation USA, Safe Kids Worldwide USA

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

Kulanthayan S, Umar RS, Hariza HA, Nasir MT, Harwant S. Compliance of proper safety helmet usage in motorcyclists. Med J Malaysia. 2000 Mar;55(1):40-4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary There will be increase in the prevalence of standard motorcycle child safety helmet usage in post intervention compared to pre-intervention There will be increase in the prevalence of standard motorcycle child safety helmet usage among primary school students after the educational session under helmet initiative program as well as after the distribution of standard motorcycle child safety helmets.
The educational session under helmet initiative program will provide important information about the risks of riding without standard helmet include the severity of injury to children. This will be an effective effort for continuous usage of standard helmet among child pillion riders
Distribution of standard motorcycle child safety helmets will be able to increase the ownership of standard child helmet especially among those who; hence will increase the prevalence of standard motorcycle child safety helmet usage
through study completion, an average of 1 year
Secondary There will be increase in the prevalence of proper standard motorcycle safety helmet usage in post intervention compared to pre-intervention Wearing a properly fitted, safety-approved motorcycle helmet will able to reduce head injuries.
The educational session under helmet initiative program will provide important information about the severity of injury to children due to improper helmet usage. This will be an effective effort to reduce the prevalence of head injuries among child pillion riders
through study completion, an average of 1 year
Secondary There will be increase in mean score of parents' knowledge measured using questionnaire in standard motorcycle child safety helmet usage in post intervention compared to pre-intervention The usage of standard child motorcycle helmet among child pillion riders will be more successful when they receive consistent messages from their parents.
The educational session under helmet initiative program will provide important information on the law, proper usage, risk of non-usage and the consequences to the parents which further will develope a positive attitude toward helmet wearing for children.
parents' practice in helmet usage will significantly motivates the children to wear a helmet
through study completion, an average of 1 year
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