Study Protocol for Two-Steps Parallel Randomized Controlled Trial: Pre-Clinical Usability Tests for a New Double-Chamber Syringe
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Participants Recruitment and Sample Size
2.3. Patient and Public Involvement
2.4. Randomization and Blinding
2.5. Materials
2.6. Interventions
2.7. Outcomes
2.8. Data Collection, Management, and Analysis
2.9. Ethical Considerations
2.10. Dissemination
3. Results
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Inclusion Criteria | Exclusion Criteria |
---|---|
✓ Nurses | ✓ Other health professionals |
✓ Minimum academic qualifications of a bachelor degree | ✓ Any previous contact with the device (knowledge and/or manipulation) |
✓ Experience on intravenous drug administration | ✓ Individuals who have a financial relationship with the device manufacturer and/or distributor |
Steps | Duration (Min) | Purposes |
---|---|---|
Introduction | 5 min |
|
Discussion | 30 min |
|
Conclusion | 5 min |
|
Standard Syringe | Double-Chamber Syringe | |
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Phase 1 (Drug Preparation) |
|
|
Standard Syringe | Double-Chamber Syringe | |
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Phase 2 (Drug administration) |
|
|
Phase 1 (Drug Preparation) | Phase 2 (Drug Administration) |
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Parreira, P.; Sousa, L.B.; Marques, I.A.; Santos-Costa, P.; Cortez, S.; Carneiro, F.; Cruz, A.; Salgueiro-Oliveira, A. Study Protocol for Two-Steps Parallel Randomized Controlled Trial: Pre-Clinical Usability Tests for a New Double-Chamber Syringe. Int. J. Environ. Res. Public Health 2020, 17, 8376. https://doi.org/10.3390/ijerph17228376
Parreira P, Sousa LB, Marques IA, Santos-Costa P, Cortez S, Carneiro F, Cruz A, Salgueiro-Oliveira A. Study Protocol for Two-Steps Parallel Randomized Controlled Trial: Pre-Clinical Usability Tests for a New Double-Chamber Syringe. International Journal of Environmental Research and Public Health. 2020; 17(22):8376. https://doi.org/10.3390/ijerph17228376
Chicago/Turabian StyleParreira, Pedro, Liliana B. Sousa, Inês A. Marques, Paulo Santos-Costa, Sara Cortez, Filipa Carneiro, Arménio Cruz, and Anabela Salgueiro-Oliveira. 2020. "Study Protocol for Two-Steps Parallel Randomized Controlled Trial: Pre-Clinical Usability Tests for a New Double-Chamber Syringe" International Journal of Environmental Research and Public Health 17, no. 22: 8376. https://doi.org/10.3390/ijerph17228376
APA StyleParreira, P., Sousa, L. B., Marques, I. A., Santos-Costa, P., Cortez, S., Carneiro, F., Cruz, A., & Salgueiro-Oliveira, A. (2020). Study Protocol for Two-Steps Parallel Randomized Controlled Trial: Pre-Clinical Usability Tests for a New Double-Chamber Syringe. International Journal of Environmental Research and Public Health, 17(22), 8376. https://doi.org/10.3390/ijerph17228376