Trauma-related WoundNCT05563129
Teaching First Aid and Trauma Management to School Students
A study testing First aid lessons in people with Trauma-related Wound and Head Injury, run by University of Ioannina at 1 site in Greece.
Trial summary
This proposal aims to describe research that will utilize first aid in primary education students and will attempt to identify the frequency with which the training should be repeated and the type of trainer who will carry out the training program. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Trauma-related Wound, Head Injury, Choking
- What is being tested?
- First aid lessons
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2021to 25 Nov 2023
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Students at primary schools and kindergarten, 4-9 years old
Who cannot join
- Students over 9 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Importance of Teaching First Aid and Trauma Management to Primary School Students
This proposal aims to describe research that will utilize first aid in primary education students and will attempt to identify the frequency with which the training should be repeated and the type of trainer who will carry out the training program.
Read the detailed description
The training concerns courses with theoretical knowledge and practical skills related to first aid. Taking into account children's cognitive and psychological development, students will be trained in the following topics: calling an ambulance, managing bleeding, handling an unconscious patient, drowning, and managing a head injury. Classroom teachers and specialized staff will teach classes. The evaluation of knowledge and skills will be done with a questionnaire. The evaluation will take place before and immediately after the training, two months and seven months after the training.
- Conditions
- Trauma-related Wound, Head Injury, Choking, Nose Bleed, Child, Only, Emergencies
- Being tested
- First aid lessons
- Keywords
- first aid training, children
- Medical subject headings
- Craniocerebral Trauma, Airway Obstruction, Epistaxis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First aid lessonsOther
The school children will have first aid training
| Study group | Role | What they receive |
|---|---|---|
| No first aid training | No intervention | Not described |
| First aid training | Experimental | Not described Receives: Other: First aid lessons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that know first aid
We will use questionnaire to assess this outcome
Measured: 1 day pre the training
Number of participants that learnt first aid
We will use questionnaire to assess this outcome
Measured: 1-day post the training
Comparing the results of the training about the facilitators' performance
We will use questionnaire to assess this outcome
Measured: 2 months post the training
Number of participants that retain the first aid knowledge
We will use questionnaire to assess this outcome
Measured: 7 months post the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Dec 2021
- Primary completion25 Oct 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma-related WoundStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Alexiou, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563129
- Sponsor's protocol ID
- 970/29-06-2021
- Status last verified
- Nov 2023
- First submitted
- 24 Sep 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Teaching First Aid and Trauma Management to Primary School Students
- ClinicalTrials.gov ID
- NCT05563129
- Acronym / sponsor ID
- 970/29-06-2021
- Conditions
- Trauma-related Wound, Head Injury, Choking, Nose Bleed, Child, Only, Emergencies
- Keywords
- first aid training, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 3 Oct 2022 (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.
This proposal aims to describe research that will utilize first aid in primary education students and will attempt to identify the frequency with which the training should be repeated and the type of trainer who will carry out the training program.
Detailed description
The training concerns courses with theoretical knowledge and practical skills related to first aid. Taking into account children's cognitive and psychological development, students will be trained in the following topics: calling an ambulance, managing bleeding, handling an unconscious patient, drowning, and managing a head injury. Classroom teachers and specialized staff will teach classes. The evaluation of knowledge and skills will be done with a questionnaire. The evaluation will take place before and immediately after the training, two months and seven months after the training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No first aid training | No intervention | – |
| First aid training | Experimental | Other: First aid lessons |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students at primary schools and kindergarten, 4-9 years old
Key exclusion criteria (1 listed)
- Students over 9 years old
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 |
|---|---|---|
| First aid lessonsThe school children will have first aid training | Other | First aid training |
Primary outcome
Number of participants that know first aid
Time frame: 1 day pre the training
We will use questionnaire to assess this outcome
Number of participants that learnt first aid
Time frame: 1-day post the training
We will use questionnaire to assess this outcome
Comparing the results of the training about the facilitators' performance
Time frame: 2 months post the training
We will use questionnaire to assess this outcome
Number of participants that retain the first aid knowledge
Time frame: 7 months post the training
We will use questionnaire to assess this outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First aid lessons in people with Trauma-related Wound and Head Injury, run by University of Ioannina at 1 site in Greece.
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 1 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: finished, as of the sponsor's last update on 29 Nov 2023. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that know first aid (time frame: 1 day pre the training). The study lists 4 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 29 Nov 2023.