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NCT06820437
Comparison of the Effectiveness of High Fidelity Simulation and Low Fidelity Simulation in Active External Bleeding Control Management of Caregivers of Elderly Individuals
trial testing Low-fidelity (Visually Enhanced Mental Simulation-VEMS) simulation training in Simulation Training in 30 participants. Not yet recruiting.
20 June 2025
Quick facts
| Lead sponsor | Mustafa Kemal University |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 20 February 2025 |
| Primary completion | 20 June 2025 |
| Estimated completion | 20 August 2025 |
| Sites | 2 locations across Turkey (Türkiye) |
Drugs / interventions tested
- Low-fidelity (Visually Enhanced Mental Simulation-VEMS) simulation training
- High-fidelity (simulated patient/standard patient) simulation training
Conditions studied
- Simulation Training — all drugs for Simulation Training →
- High Fidelity Simulation Training — all drugs for High Fidelity Simulation Training →
- First Aid — all drugs for First Aid →
- Informal Caregivers — all drugs for Informal Caregivers →
Sponsor
Mustafa Kemal University
Who can join
18 and older, any sex, with Simulation Training or High Fidelity Simulation Training. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06820437 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mustafa Kemal University
- Last refreshed: 11 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06820437.
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