Simulation TrainingNCT06820437
Comparison of the Effectiveness of High Fidelity Simulation and Low Fidelity Simulation in Active External Bleeding Control Management of Caregivers of Elderly Individuals
An observational study of Simulation Training and High Fidelity Simulation Training, run by Mustafa Kemal University at 2 sites in Turkey (Türkiye).
Trial summary
The elderly population is increasing worldwide. Due to the increase in the elderly population, emergencies related to ageing are also encountered more frequently. One of these emergencies is trauma in the elderly. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Simulation Training, High Fidelity Simulation Training, First Aid
- What is being tested?
- Low-fidelity (Visually Enhanced Mental Simulation-VEMS) simulation training and High-fidelity (simulated patient/standard patient) simulation training
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Feb 2025to 20 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population of the study will consist of non-health professional caregivers of elderly individuals living in Antakya district of Hatay province. The sample size was determined by calculating in the G Power program. With 95% confidence (1-α), 95% test power (1-β), d=1.387 effect size and two-way independent samples t-test, the number of samples to be taken in each group was determined as 15 (Scalese et al., 2022). After the theoretical training, participants will be randomly assigned to groups by lottery method. With the support of neighborhood mukhtars, individuals who care for elderly individuals will be contacted and informed about the study, and volunteer caregivers who are not health professionals will be included in the study by signing informed consent.
Who may be able to join
- Not having received the theoretical first assessment and first aid training in external bleeding
- No cognitive and communication problems that can actively participate in the study
- Not being a health professional
- Not being a paid caregiver
Who cannot join
- The participant declares that he/she wants to leave at any stage of the study
- Not participating in any of the simulation phases
- Not participating in the implementation of the data collection tools to be applied
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Hatay Mustafa Kemal University
Antakya, Hatay, 31001
Tayfur Sökmen Kampüsü, +90 0850 377 80 00, prmsongul@gmail.com
Hatay Mustafa Kemal University
Hatay, Antakya, 31001
Songul Demir, PhD Student, +90 0850 377 80 00, rektorlukyaziisleri@mku.edu.tr
Zahide Tuncbilek, Associate professor, +90 0312 305 15 80 / 185, ztuna@hacettepe.edu.tr
About this study
Official title: Comparison of the Effectiveness of High-Fidelity Simulation and Low-Fidelity Simulation in the Management of Active External Bleeding Control by Caregivers of Elderly Individuals
The elderly population is increasing worldwide. Due to the increase in the elderly population, emergencies related to ageing are also encountered more frequently. One of these emergencies is trauma in the elderly. Traumas are frequently seen in elderly individuals due to physiological deficiencies related to aging as well as environmental factors. External bleeding caused by trauma is also encountered. If first aid to stop active external bleeding is not administered in a timely and correct manner, death due to bleeding can occur. Nowadays, elderly individuals live either with their families, alone, or in institutions. In the event of external bleeding, either the individual themselves, caregiving family members, or staff at the institution should be able to perform first aid to stop the bleeding.
Elderly individuals may not be able to perform first aid due to cognitive and neurological deficiencies. The ability of caregivers to provide first aid can be life-saving. If caregivers of elderly individuals are trained in first aid for external bleeding, they can quickly and correctly administer first aid to stop the bleeding. First aid training often consists of didactic education and demonstrations. A training strategy that ensures knowledge retention and skill acquisition is simulation training. This study aims to evaluate and compare the effectiveness of high-fidelity simulation and low-fidelity (Visually Enhanced Mental Simulation - VEMS) simulation in the skills of caregivers for elderly individuals in managing active external bleeding control.
The population of the study will consist of non-health professional caregivers of elderly individuals living in Antakya district of Hatay province. The sample size, calculated using the G Power program, has been determined to include 30 caregivers of elderly individuals. The study consists of four main work packages. In the first stage, the simulation environment will be prepared, and in the second stage, a preliminary application of the project will be conducted. In the third stage, the implementation of the research and the completion of checklists will be ensured. For this, volunteer caregivers of elderly individuals will be identified. After theoretical training is given to the participants, they will be assigned to intervention group 1 (VEMS) and intervention group 2 (high-fidelity simulation) using simple randomization. Following a pre-assessment with low-fidelity simulation, participants will undergo simulation training according to their intervention groups. Subsequently, a final assessment will be conducted using the same lowfidelity simulation. In the final stage, data analysis and interpretation of the findings will be carried out. The collected data will be analyzed statistically, and the significance level will be accepted as p<0.05. With this study, insight will be provided into the effectiveness of VEMS and high-fidelity simulation in first aid training for active external bleeding for caregivers of elderly individuals. On the other hand, it is planned that the project results will be published in at least one article in journals indexed in the SSCI Expanded.
- Conditions
- Simulation Training, High Fidelity Simulation Training, First Aid, Informal Caregivers, Elderly, Bleeding
- Being tested
- Low-fidelity (Visually Enhanced Mental Simulation-VEMS) simulation training, High-fidelity (simulated patient/standard patient) simulation training
- Keywords
- Elderly caregivers, external bleeding, elderly, first aid training, simulation, visually enhanced mental simulation, high fidelity simulation
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fidelity (Visually Enhanced Mental Simulation-VEMS) simulation trainingOther
Intervention group 1: Low-fidelity (Visually Enhanced Mental Simulation-VEMS) simulation training will be conducted on active external bleeding control management skills of caregivers of elderly individuals. In this intervention poster and cards will be used.
High-fidelity (simulated patient/standard patient) simulation trainingOther
Intervention group 2: High-fidelity (simulated patient/standard patient) simulation training will be conducted for caregivers of elderly individuals in active external bleeding control management skills. Standardized patient who will act as elderly will be used in this intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1: | VEMS (low-fidelity simulation) Receives: Other: Low-fidelity (Visually Enhanced Mental Simulation-VEMS) simulation training | |
| Intervention group 2 | High-fidelity (simulated patient/standard patient) simulation Receives: Other: High-fidelity (simulated patient/standard patient) simulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active external bleeding control management skills of caregivers of elderly individuals assesed by "Active External Bleeding Management Asssesment Form"
Active External Bleeding Management Asssesment Form was developed by the researchers. It includes 13 items which evaluate first aid inteventions for external bleeding. Expert opininons were taken for content validity of the form.
Measured: 1st - 4 th months
Secondary outcomes (1)
Obtaining the opinions of caregivers of elderly individuals on the interventions by using Simulation Assesment Form
The opinions of the caregivers of elderly individuals about the interventions, which are high fidelity simulation and low fidelity simulation in active external bleeding control management skills, will be obtained through questionnaires developed by the researchers in the light of the literature by taking expert opinion. The form includes likert type 12 items.
Measured: 1st-4th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Simulation TrainingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Demir, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820437
- Sponsor's protocol ID
- 2023/16
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abou-Raya S, ElMeguid LA. Road traffic accidents and the elderly. Geriatr Gerontol Int. 2009 Sep;9(3):290-7. doi: 10.1111/j.1447-0594.2009.00535.x.
PubMed 19702940Abatzis VT, Littlewood KE. Debriefing in Simulation and Beyond. Int Anesthesiol Clin. 2015 Fall;53(4):151-62. doi: 10.1097/AIA.0000000000000070.
PubMed 26397791
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of High-Fidelity Simulation and Low-Fidelity Simulation in the Management of Active External Bleeding Control by Caregivers of Elderly Individuals
- ClinicalTrials.gov ID
- NCT06820437
- Acronym / sponsor ID
- 2023/16
- Conditions
- Simulation Training, High Fidelity Simulation Training, First Aid, Informal Caregivers, Elderly, Bleeding
- Keywords
- Elderly caregivers, external bleeding, elderly, first aid training, simulation, visually enhanced mental simulation, high fidelity simulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 11 Feb 2025 (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 elderly population is increasing worldwide. Due to the increase in the elderly population, emergencies related to ageing are also encountered more frequently. One of these emergencies is trauma in the elderly. Traumas are frequently seen in elderly individuals due to physiological deficiencies related to aging as well as environmental factors. External bleeding caused by trauma is also encountered. If first aid to stop active external bleeding is not administered in a timely and correct manner, death due to bleeding can occur. Nowadays, elderly individuals live either with their families, alone, or in institutions. In the event of external bleeding, either the individual themselves, caregiving family members, or staff at the institution should be able to perform first aid to stop the bleeding.
Elderly individuals may not be able to perform first aid due to cognitive and neurological deficiencies. The ability of caregivers to provide first aid can be life-saving. If caregivers of elderly individuals are trained in first aid for external bleeding, they can quickly and correctly administer first aid to stop the bleeding. First aid training often consists of didactic education and demonstrations. A training strategy that ensures knowledge retention and skill acquisition is simulation training. This study aims to evaluate and compare the effectiveness of high-fidelity simulation and low-fidelity (Visually Enhanced Mental Simulation - VEMS) simulation in the skills of caregivers for elderly individuals in managing active external bleeding control.
The population of the study will consist of non-health professional caregivers of elderly individuals living in Antakya district of Hatay province. The sample size, calculated using the G Power program, has been determined to include 30 caregivers of elderly individuals. The study consists of four main work packages. In the first stage, the simulation environment will be prepared, and in the second stage, a preliminary application of the project will be conducted. In the third stage, the implementation of the research and the completion of checklists will be ensured. For this, volunteer caregivers of elderly individuals will be identified. After theoretical training is given to the participants, they will be assigned to intervention group 1 (VEMS) and intervention group 2 (high-fidelity simulation) using simple randomization. Following a pre-assessment with low-fidelity simulation, participants will undergo simulation training according to their intervention groups. Subsequently, a final assessment will be conducted using the same lowfidelity simulation. In the final stage, data analysis and interpretation of the findings will be carried out. The collected data will be analyzed statistically, and the significance level will be accepted as p<0.05. With this study, insight will be provided into the effectiveness of VEMS and high-fidelity simulation in first aid training for active external bleeding for caregivers of elderly individuals. On the other hand, it is planned that the project results will be published in at least one article in journals indexed in the SSCI Expanded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1: | – | Other: Low-fidelity (Visually Enhanced Mental Simulation-VEMS) simulation trainingVEMS (low-fidelity simulation) |
| Intervention group 2 | – | Other: High-fidelity (simulated patient/standard patient) simulation trainingHigh-fidelity (simulated patient/standard patient) simulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study will consist of non-health professional caregivers of elderly individuals living in Antakya district of Hatay province. The sample size was determined by calculating in the G Power program. With 95% confidence (1-α), 95% test power (1-β), d=1.387 effect size and two-way independent samples t-test, the number of samples to be taken in each group was determined as 15 (Scalese et al., 2022). After the theoretical training, participants will be randomly assigned to groups by lottery method. With the support of neighborhood mukhtars, individuals who care for elderly individuals will be contacted and informed about the study, and volunteer caregivers who are not health professionals will be included in the study by signing informed consent.
Key inclusion criteria (4 listed)
- Not having received the theoretical first assessment and first aid training in external bleeding
- No cognitive and communication problems that can actively participate in the study
- Not being a health professional
- Not being a paid caregiver
Key exclusion criteria (3 listed)
- The participant declares that he/she wants to leave at any stage of the study
- Not participating in any of the simulation phases
- Not participating in the implementation of the data collection tools to be applied
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 |
|---|---|---|
| Low-fidelity (Visually Enhanced Mental Simulation-VEMS) simulation trainingIntervention group 1: Low-fidelity (Visually Enhanced Mental Simulation-VEMS) simulation training will be conducted on active external bleeding control management skills of caregivers of elderly individuals. In this intervention poster and cards will be used. | Other | Intervention group 1: |
| High-fidelity (simulated patient/standard patient) simulation trainingIntervention group 2: High-fidelity (simulated patient/standard patient) simulation training will be conducted for caregivers of elderly individuals in active external bleeding control management skills. Standardized patient who will act as elderly will be used in this intervention. | Other | Intervention group 2 |
Primary outcome
Active external bleeding control management skills of caregivers of elderly individuals assesed by "Active External Bleeding Management Asssesment Form"
Time frame: 1st - 4 th months
Active External Bleeding Management Asssesment Form was developed by the researchers. It includes 13 items which evaluate first aid inteventions for external bleeding. Expert opininons were taken for content validity of the form.
1 secondary outcome
Obtaining the opinions of caregivers of elderly individuals on the interventions by using Simulation Assesment Form
Time frame: 1st-4th months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Background: PubMed 19702940Abou-Raya S, ElMeguid LA. Road traffic accidents and the elderly. Geriatr Gerontol Int. 2009 Sep;9(3):290-7. doi: 10.1111/j.1447-0594.2009.00535.x.
- Background: PubMed 26397791Abatzis VT, Littlewood KE. Debriefing in Simulation and Beyond. Int Anesthesiol Clin. 2015 Fall;53(4):151-62. doi: 10.1097/AIA.0000000000000070.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Simulation Training and High Fidelity Simulation Training, run by Mustafa Kemal University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Songül Demir (+90 0 505 571 86 71, prmsongul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active external bleeding control management skills of caregivers of elderly individuals assesed by "Active External Bleeding Management Asssesment Form" (time frame: 1st - 4 th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06820437, which also lists 2 linked publications.
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 11 Feb 2025.