An observational study in Simulation Training, High Fidelity Simulation Training and First Aid, sponsored by Mustafa Kemal University. Not yet recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Mustafa Kemal University · Observational
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.
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This study's planned enrollment of 30 is below the median of 150 across 897 observational studies indexed under Hemorrhage.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
VEMS (low-fidelity simulation)
Other: Low-fidelity (Visually Enhanced Mental Simulation-VEMS) simulation training
High-fidelity (simulated patient/standard patient) simulation
Other: High-fidelity (simulated patient/standard patient) simulation training
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.
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.
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.
Time frame: 1st - 4 th months
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.
Time frame: 1st-4th months
Plan to share: Undecided
Start is estimated for Feb 2025; primary completion for Jun 2025, 4 months later.
Of 339 non-industry observational studies under Hemorrhage, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 57. This study's planned 4 months is below that.
Counting every sponsor, half of 364 studies reached it within 30 months; a quarter within 14 and three quarters within 57.
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This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Mustafa Kemal University