Integrating the Fundamentals of Care Framework Into Italian Nursing Education
NCT ID: NCT05177627
Last Updated: 2022-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2022-01-31
2023-03-31
Brief Summary
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A multi-centre randomized controlled trial will be conducted to evaluate the effectiveness of integrating the FoC framework into nursing education. Outcomes perceived by patients and their families relate to meeting the fundamental care needs.
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Detailed Description
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FOCs are often implicit or invisible in nursing education, taught as an introductory part in the first year of the course and rarely addressed in subsequent years. The study aims to improve patient outcomes by educational interventions to integrate the FUNDAMENTAL OF CARE FRAMEWORK into nursing education.
Objectives: The substantive objectives of the study are: 1) To describe how nurses, internship preceptors, students and patients and their families perceive fundamental care; 2) Assessing learning process in developing FOC skills of nursing students; 3) Assessing nursing students perception of the learning environment and the supervision related to learning of FOC skills during the clinical internship; 4) Assessing the perceived outcomes of patients and their families related to meet the fundamental care needs.
Design: multi-centre randomized controlled trial
Sample: Students of nursing degree enrolled in the first year of the course, internship preceptors nurses who work in the internship departments of students enrolled in the first year of nursing degree, and patients over the age of 18, cognitively intact, assisted in the internship departments, who have the following three needs: (1) nutrition; (2) elimination; (3) personal hygiene will be included.
Measures: All outcomes will be measured with established criteria and with instruments used in previous studies or developed by the investigators and found validated and reliable.
Analysis: In addition to descriptive statistics, statistical tests to analyze differences in the scores between groups will be used to address the objectives.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. experimental group with educational interventions of integration of the FoC framework (learning according to the FoC framework with the contents of the current curriculum);
2. control group without intervention (learning according to the current educational model and the contents of the current curriculum); A researcher not involved in the educational interventions and data collection of the study at the University of Genoa will randomly assign in a 1: 1 ratio the students to the two groups extracted from the lists of students provided by the universities based on a table of random numbers.
SUPPORTIVE_CARE
SINGLE
Study Groups
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Fundamental of Care Framework implementation
Educational interventions related to introduction of FoC framework and taking charge of patients and their fundamental needs will be realized during theoretical, simulation and internship learning.
Theoretical and classroom learning interventions
aim of intervention: introduce students to the conceptual framework of fundamental of care, focus on three dimensions necessary for the delivery of high-quality fundamental care (the nurse-patient relationship; addressing different fundamental needs; and a context that supports these goals)
components and activities:
* educational interventions to understand how the communication and the relationship of trust between nurse and patient are the prerequisites for high quality nursing care;
* drawing attention to five essential relational elements for establishing the nurse-patient relationship (Trust; Focus; Anticipate; Know; Evaluate)
mode of delivery:
* classroom lessons on philosophies and theories on communication and trust
* small-group learning on realistic cases focused on fundamental needs to develop reflexivity, analytical skills, investigation
duration of the intervention: 12 hours of theoretical and classroom learning
Simulation interventions
aim of intervention:
To develop active listening and use of non-verbal and verbal communication skills to establish a therapeutic relationship based on compassion, trust and respect; to apply the FoC conceptual framework, reflexivity and analytical skills to meet patient fundamental needs.
Students will express these goals during simulation activities with behaviours outlined by the FoC framework.
components and activities: - Implementation of communication simulation activities to develop interaction skills with patients; Implementation of simulation activities to apply the FoC conceptual framework and reflection to meet patient fundamental needs in realistic scenarios.
mode of delivery:
\- simulation activities on communication and trust Use ad hoc validated scenarios to apply the FoC conceptual framework to develop reflection and meet patient fundamental needs.
duration of the intervention: 25 hours
Internship interventions
Aim of intervention: to apply active listening and non-verbal communication skills; to use the FoC conceptual framework, reflexivity, and analytical skills to meet patient fundamental needs.
Students will express these goals during simulation activities with behaviours outlined by the FoC framework.
components and activities:
\- to establish effective and trusting communication with patients to demonstrate compassion and respect and to enable patients to remain calm, involved and dignified; to apply the FoC conceptual framework to meet patient fundamental needs.
mode of delivery:
* attendance of clinical internship
* analysis and reflections guided by the clinical preceptor on real cases using elements of FoC conceptual framework.
duration of the intervention: 150 hours of internship.
No Fundamental of Care Framework implementation
the participants of no intervention group will receive the standard training as scheduled on the curriculum
No interventions assigned to this group
Interventions
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Theoretical and classroom learning interventions
aim of intervention: introduce students to the conceptual framework of fundamental of care, focus on three dimensions necessary for the delivery of high-quality fundamental care (the nurse-patient relationship; addressing different fundamental needs; and a context that supports these goals)
components and activities:
* educational interventions to understand how the communication and the relationship of trust between nurse and patient are the prerequisites for high quality nursing care;
* drawing attention to five essential relational elements for establishing the nurse-patient relationship (Trust; Focus; Anticipate; Know; Evaluate)
mode of delivery:
* classroom lessons on philosophies and theories on communication and trust
* small-group learning on realistic cases focused on fundamental needs to develop reflexivity, analytical skills, investigation
duration of the intervention: 12 hours of theoretical and classroom learning
Simulation interventions
aim of intervention:
To develop active listening and use of non-verbal and verbal communication skills to establish a therapeutic relationship based on compassion, trust and respect; to apply the FoC conceptual framework, reflexivity and analytical skills to meet patient fundamental needs.
Students will express these goals during simulation activities with behaviours outlined by the FoC framework.
components and activities: - Implementation of communication simulation activities to develop interaction skills with patients; Implementation of simulation activities to apply the FoC conceptual framework and reflection to meet patient fundamental needs in realistic scenarios.
mode of delivery:
\- simulation activities on communication and trust Use ad hoc validated scenarios to apply the FoC conceptual framework to develop reflection and meet patient fundamental needs.
duration of the intervention: 25 hours
Internship interventions
Aim of intervention: to apply active listening and non-verbal communication skills; to use the FoC conceptual framework, reflexivity, and analytical skills to meet patient fundamental needs.
Students will express these goals during simulation activities with behaviours outlined by the FoC framework.
components and activities:
\- to establish effective and trusting communication with patients to demonstrate compassion and respect and to enable patients to remain calm, involved and dignified; to apply the FoC conceptual framework to meet patient fundamental needs.
mode of delivery:
* attendance of clinical internship
* analysis and reflections guided by the clinical preceptor on real cases using elements of FoC conceptual framework.
duration of the intervention: 150 hours of internship.
Eligibility Criteria
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Inclusion Criteria
* All internship preceptors nurses who work in the internship departments of students enrolled in the first year of nursing degree will choose to participate in the study.
* All patients over the age of 18 assisted in the internship departments who choose to participate in the study who have the following three needs: (1) nutrition; (2) elimination; (3) personal hygiene.
Exclusion Criteria
19 Years
ALL
Yes
Sponsors
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University of Genova
OTHER
Responsible Party
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Milko Zanini
Assistant Professor
Principal Investigators
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Annamaria Bagnasco, Prof
Role: PRINCIPAL_INVESTIGATOR
Department of Health Sciences, University of Genoa
Central Contacts
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References
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Kitson A, Conroy T, Wengstrom Y, Profetto-McGrath J, Robertson-Malt S. Defining the fundamentals of care. Int J Nurs Pract. 2010 Aug;16(4):423-34. doi: 10.1111/j.1440-172X.2010.01861.x.
Feo R, Kitson A. Promoting patient-centred fundamental care in acute healthcare systems. Int J Nurs Stud. 2016 May;57:1-11. doi: 10.1016/j.ijnurstu.2016.01.006. Epub 2016 Feb 1.
Bagnasco A, Timmins F, de Vries JMA, Aleo G, Zanini M, Catania G, Sasso L. Understanding and addressing missed care in clinical placements - Implications for nursing students and nurse educators. Nurse Educ Today. 2017 Sep;56:1-5. doi: 10.1016/j.nedt.2017.05.015. Epub 2017 May 23.
Feo R, Rasmussen P, Wiechula R, Conroy T, Kitson A. Developing effective and caring nurse-patient relationships. Nurs Stand. 2017 Mar 8;31(28):54-63. doi: 10.7748/ns.2017.e10735.
Feo R, Conroy T, Alderman J, Kitson A. Implementing fundamental care in clinical practice. Nurs Stand. 2017 Apr 5;31(32):52-62. doi: 10.7748/ns.2017.e10765.
Huisman-de Waal G, Feo R, Vermeulen H, Heinen M. Students' perspectives on basic nursing care education. J Clin Nurs. 2018 Jun;27(11-12):2450-2459. doi: 10.1111/jocn.14278.
Voldbjerg SL, Laugesen B, Bahnsen IB, Jorgensen L, Sorensen IM, Gronkjaer M, Sorensen EE. Integrating the fundamentals of care framework in baccalaureate nursing education: An example from a nursing school in Denmark. J Clin Nurs. 2018 Jun;27(11-12):2506-2515. doi: 10.1111/jocn.14354.
Saarikoski M, Warne T, Kaila P, Leino-Kilpi H. The role of the nurse teacher in clinical practice: an empirical study of Finnish student nurse experiences. Nurse Educ Today. 2009 Aug;29(6):595-600. doi: 10.1016/j.nedt.2009.01.005. Epub 2009 Feb 18.
Bagnasco A, Lusignani M, Pagnucci N, Sallai T, Catania G, Napolitano F, Dal Molin A, Mazzoleni B, Cosmai S, Cattani D, Mansi L, Montani D, Zavaglio A, Sanvito P, Cartabia C, Consolo L, Giuseppe L, Zanini M, Sasso L. Italian Version of the Fundamentals of Care Framework and the Fundamentals of Care Practice Process: A Comprehensive Validation Study. J Adv Nurs. 2025 Jul 28. doi: 10.1111/jan.70099. Online ahead of print.
Other Identifiers
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FoC-FORM 2021
Identifier Type: -
Identifier Source: org_study_id
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