Burn InjuryNCT03618940
Module on Preventing Fire, Burns and Scalds Injury Among Children
A study testing Knowledge and Attitude on burn prevention in people with Burn Injury, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
The main aim of this intervention study is to test the hypothesis if school based educational intervention program will significantly improve the knowledge of primary school student on childhood burn prevention in Kuala Lumpur. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn Injury
- What is being tested?
- Knowledge and Attitude on burn prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,335 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students who are aged 7 till 11 years old
- Parent or guardian of each selected student above
Who cannot join
- ● Students under special needs class (Pendidikan Khas)
Trial locations and contacts
1 site in 1 country.
KULANTHAYAN KC MANI contact
Malaysia1 site, 1 recruiting
- Recruiting
Primary Schools in Sentul District
Sentul, Kuala Lumpur, 51100
KULANTHAYAN KC MANI, kulan@upm.edu.my
About this study
Official title: Developing, Implementing and Evaluating Intervention Module on Preventing Fire, Burns and Scalds Injury Among Children Ages 7 to 11 Years In Sentul, Kuala Lumpur
The main aim of this intervention study is to test the hypothesis if school based educational intervention program will significantly improve the knowledge of primary school student on childhood burn prevention in Kuala Lumpur. The secondary aim the evaluate the association of demographics background, burn injury history with knowledge on burn. The study was conducted in 12 primary school in Kuala Lumpur from 1st January 2015 to 31st December 2017 in three different phases.
Read the detailed description
According to World Health Organization data, approximately 10% of all unintentional injury deaths are due to fire-related burns. In Malaysia, burn represent about 5.6% (745 cases) of all injuries among children. As childhood burn was not considered as a child health problem comparing to other childhood illnesses, parents and children tends to have less priority in overcome this issue. This highlights the need to transfer the knowledge especially to the children on the burn prevention. By implementing this module on preventing fire, burns and scalds injury among children, knowledge on main causes of burns and their immediate management can be improved at young age.
- Conditions
- Burn Injury
- Being tested
- Knowledge and Attitude on burn prevention
- Keywords
- fire, burn injury, children, scalds
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge and Attitude on burn preventionBehavioural
1.Introduction to Home Safety
2 Fire Safety \& Burn Safety (Cooking Safety, Safety around Motorcycle Exhaust \&First Aid for Minor Burns
3 Electrical Safety (Safety around Electrical \& Appliances \& Outlets)
4 Firecrackers Safety (Safety around Firecrackers \& Open Flames)
- Escaping from Fire (Escaping from Fire, Calling for Help, Stop, Drop \& Roll, Emergency Calling Number (By Fire Department Kuala Lumpur), Show equipment/gear that firefighters use, Demonstrate how to use the fire extinguisher, Crawl low in smoke
| Study group | Role | What they receive |
|---|---|---|
| School-based educational intervention | Experimental | 1. assessed for knowledge and attitude on burn injury prevention
2. underwent the School-based educational intervention
3. impact evaluation
4. Output evaluation 3 months after School-based educational intervention Receives: Behavioral: Knowledge and Attitude on burn prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve the knowledge on burn prevention among children
Educational intervention was conducted to improve the knowledge on burn prevention among children. The intervention uses Module on Preventing Fire, Burns and Scalds which consist of 5 main topics;
- Introduction to Home Safety
- Fire Safety \& Burn Safety
- Electrical Safety
- Firecrackers Safety
- Escaping from Fire
The knowledge on burn prevention was assessed using questionnaire before and after intervention. The total score of knowledge was further categorized into poor moderate and good.
The change in mean score of knowledge was assessed using paired-t test and ANCOVA test
Measured: through study completion, an average of 2 year
Improve the attitude on burn prevention among children
Educational intervention was conducted to improve the attitude on burn prevention among children. The intervention uses Module on Preventing Fire, Burns and Scalds
The attitude on burn prevention was assessed using questionnaire before and after intervention. The total score of attitute was further categorized into poor moderate and good.
The change in mean score of attitude was assessed using paired-t test and ANCOVA test
Measured: through study completion, an average of 2 year
Secondary outcomes (5)
Socio-demographic characteristic was associated with knowledge on burn prevention among children
A structured questionnaire was used to assess the socio-demographic characteristics of the children (age, gender, ethnicity, family income, educational background of parents, type of residential and number of siblings)
the association between socio-demographic characteristics and knowledge on burn prevention among children was tested using ANOVA and Regression analysis
Measured: first year of the study (1 year)
Socio-demographic characteristic was associated with attitude on burn prevention among children
A structured questionnaire was used to assess the socio-demographic characteristics of the children (age, gender, ethnicity, family income, educational background of parents, type of residential and number of siblings)
the association between socio-demographic characteristics and attitude on burn prevention among children was tested using ANOVA and Regression analysis
Measured: first year of the study (1 year)
Burn injuries was associated with knowledge on burn prevention among children
A structured questionnaire was used to gather information of burn injuries (history of burn, duration, location, severity)
the association between burn injury and knowledge on burn prevention among children was tested using ANOVA and Regression analysis
Measured: first year of the study (1 year)
Burn injuries was associated with attitude on burn prevention among children
A structured questionnaire was used to gather information of burn injuries (history of burn, duration, location, severity)
the association between burn injury and attitude on burn prevention among children was tested using ANOVA and Regression analysis
Measured: first year of the study (1 year)
Educational Module on Preventing Fire, Burns and Scalds Injury will be developed based on five main issues identified in pre-intervention phase
Education module will developed based on 5 main topics as identified in phase I (pre-intervention);
- Introduction to Home Safety
- Fire Safety \& Burn Safety
- Electrical Safety
- Firecrackers Safety
- Escaping from Fire
The module will be used as teaching materials on on Preventing Fire, Burns and Scalds Injury in primary school
Measured: second year of the study (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,335 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Honeywell Home Solutions USA, Safe Kids Worldwide USA
- Responsible party
- Principal investigator, Assoc Prof Dr Kulanthayan K.C. Mani, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618940
- Sponsor's protocol ID
- Child Fire and Burn Injury
- Status last verified
- Aug 2018
- First submitted
- 16 Jul 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: plan to share the data for international collaboration or policy making
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing, Implementing and Evaluating Intervention Module on Preventing Fire, Burns and Scalds Injury Among Children Ages 7 to 11 Years In Sentul, Kuala Lumpur
- ClinicalTrials.gov ID
- NCT03618940
- Acronym / sponsor ID
- Child Fire and Burn Injury
- Conditions
- Burn Injury
- Keywords
- fire, burn injury, children, scalds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,335 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Honeywell Home Solutions USA, Safe Kids Worldwide USA
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this intervention study is to test the hypothesis if school based educational intervention program will significantly improve the knowledge of primary school student on childhood burn prevention in Kuala Lumpur. The secondary aim the evaluate the association of demographics background, burn injury history with knowledge on burn. The study was conducted in 12 primary school in Kuala Lumpur from 1st January 2015 to 31st December 2017 in three different phases.
Detailed description
According to World Health Organization data, approximately 10% of all unintentional injury deaths are due to fire-related burns. In Malaysia, burn represent about 5.6% (745 cases) of all injuries among children. As childhood burn was not considered as a child health problem comparing to other childhood illnesses, parents and children tends to have less priority in overcome this issue. This highlights the need to transfer the knowledge especially to the children on the burn prevention. By implementing this module on preventing fire, burns and scalds injury among children, knowledge on main causes of burns and their immediate management can be improved at young age.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| School-based educational intervention | Experimental | Behavioral: Knowledge and Attitude on burn prevention1. assessed for knowledge and attitude on burn injury prevention 2. underwent the School-based educational intervention 3. impact evaluation 4. Output evaluation 3 months after School-based educational intervention |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Students who are aged 7 till 11 years old
- Parent or guardian of each selected student above
Key exclusion criteria (1 listed)
- ● Students under special needs class (Pendidikan Khas)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knowledge and Attitude on burn prevention1.Introduction to Home Safety 2 Fire Safety \& Burn Safety (Cooking Safety, Safety around Motorcycle Exhaust \&First Aid for Minor Burns 3 Electrical Safety (Safety around Electrical \& Appliances \& Outlets) 4 Firecrackers Safety (Safety around Firecrackers \& Open Flames) 5. Escaping from Fire (Escaping from Fire, Calling for Help, Stop, Drop \& Roll, Emergency Calling Number (By Fire Department Kuala Lumpur), Show equipment/gear that firefighters use, Demonstrate how to use the fire extinguisher, Crawl low in smoke | Behavioural | School-based educational intervention |
Primary outcome
Improve the knowledge on burn prevention among children
Time frame: through study completion, an average of 2 year
Educational intervention was conducted to improve the knowledge on burn prevention among children. The intervention uses Module on Preventing Fire, Burns and Scalds which consist of 5 main topics; 1. Introduction to Home Safety 2. Fire Safety \& Burn Safety 3. Electrical Safety 4. Firecrackers Safety 5. Escaping from Fire The knowledge on burn prevention was assessed using questionnaire before and after intervention. The total score of knowledge was further categorized into poor moderate and good. The change in mean score of knowledge was assessed using paired-t test and ANCOVA test
Improve the attitude on burn prevention among children
Time frame: through study completion, an average of 2 year
Educational intervention was conducted to improve the attitude on burn prevention among children. The intervention uses Module on Preventing Fire, Burns and Scalds The attitude on burn prevention was assessed using questionnaire before and after intervention. The total score of attitute was further categorized into poor moderate and good. The change in mean score of attitude was assessed using paired-t test and ANCOVA test
5 secondary outcomes
Socio-demographic characteristic was associated with knowledge on burn prevention among children
Time frame: first year of the study (1 year)
Socio-demographic characteristic was associated with attitude on burn prevention among children
Time frame: first year of the study (1 year)
Burn injuries was associated with knowledge on burn prevention among children
Time frame: first year of the study (1 year)
Burn injuries was associated with attitude on burn prevention among children
Time frame: first year of the study (1 year)
Educational Module on Preventing Fire, Burns and Scalds Injury will be developed based on five main issues identified in pre-intervention phase
Time frame: second year of the study (24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Individual participant dataSharing planned: Undecided. plan to share the data for international collaboration or policy making
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KULANTHAYAN KC MANI contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge and Attitude on burn prevention in people with Burn Injury, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KULANTHAYAN KC MANI (kulan@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve the knowledge on burn prevention among children (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.