Nursing StudentsFoC-FORMNCT05177627
Integrating the Fundamentals of Care Framework Into Italian Nursing Education
A study testing Theoretical and classroom learning interventions, Simulation interventions and Internship interventions in people with Nursing Students, run by University of Genova.
Trial summary
Research has shown a gap in what is important to patients and what is important to nurses when providing care. When the patient's fundamental needs are not recognized, such as hygiene, nutrition, mobilization, communication, he feels humiliated, ignored. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Students
- What is being tested?
- Theoretical and classroom learning interventions, Simulation interventions and Internship interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All students of nursing degree enrolled in the first year of the course who will choose to participate in the study
- 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.
Who cannot join
- Patients who are unable to answer the questionnaire independently, with altered mental status, with hospitalization of fewer than 24 hours
Trial locations and contacts
No sites are listed yet.
About this study
Research has shown a gap in what is important to patients and what is important to nurses when providing care. When the patient's fundamental needs are not recognized, such as hygiene, nutrition, mobilization, communication, he feels humiliated, ignored. The study aims to improve patient outcomes by educational interventions to integrate the Fundamental of Care (FoC) framework into nursing education.
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.
Read the detailed description
Background and Significance: Since 2010, to fill the gap in what is essential when providing care in a complex and challenging environment, both for patients and nurses, a line of research has developed to study the fundamental of nursing care. The "Fundamentals of Care (FoC) Frameworks" defines FoC as fundamental activities for the patient, through which the patient feels at the centre of care and feels attention and respect around him. The framework outlines three dimensions necessary for delivering high-quality fundamental care: the nurse-patient relationship; addressing different fundamental needs; and a context that supports these goals. A positive and trusting nurse-patient relationship is the basis for delivering fundamental care and forms the core of the framework.
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
- Nursing Students
- Being tested
- Theoretical and classroom learning interventions, Simulation interventions, Internship interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theoretical and classroom learning interventionsOther
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 interventionsOther
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 interventionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fundamental of Care Framework implementation | Experimental | 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. Receives: Other: Theoretical and classroom learning interventions; Other: Simulation interventions; Other: Internship interventions |
| No Fundamental of Care Framework implementation | No intervention | the participants of no intervention group will receive the standard training as scheduled on the curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
technical and relational FOC based performance of students after simulation.
Technical and relational performance acquired on fundamental of care will be assessed by Objective Clinical Structured Examination (OSCE). Scenarios built ad hoc for applying the FoC conceptual framework will be used as an evaluation test. Checklists will be used for the assessment of technical skills and observation grids to assess communication skills.
The student communication performance will be evaluated using a validated assessment grid (Guilbert, 1990), which consist of four variables (i.e., terminology, listening, attention, and clarity), broken down into five levels of expected, observable communicative behaviours. Values between -2 and +2 will be used to evaluate every variable.
Checklists consist of a list of tasks. Each task will be evaluated with a score of 0 if not performed or performed incorrectly, with a score of 1 if performed correctly. The passing score is 80% of the tasks performed correctly.
Measured: At the end of simulation learning. (approximately 7 months after the beginning of the study)
technical and relational FOC based performance of students after internship.
Technical and relational performance acquired on fundamental of care will be assessed by Objective Clinical Structured Examination (OSCE). Scenarios built ad hoc for applying the FoC conceptual framework will be used as an evaluation test. Checklists will be used for the assessment of technical skills and observation grids to assess communication skills.
The student communication performance will be evaluated using a validated assessment grid (Guilbert, 1990), which consist of four variables (i.e., terminology, listening, attention, and clarity), broken down into five levels of expected, observable communicative behaviours. Values between -2 and +2 will be used to evaluate every variable.
Checklists consist of a list of tasks. Each task will be evaluated with a score of 0 if not performed or performed incorrectly, with a score of 1 if performed correctly. The passing score is 80% of the tasks performed correctly.
Measured: At the end of internship learning. (approximately 10 months after the beginning of the study)
Secondary outcomes (4)
Change of perception of fundamental of care by nurses, internship preceptors and students
All nurses working in the internship departments will be asked to answer the questionnaire that investigates how nurses perceive fundamental care concerning the importance, the frequency of implementation and the degree of responsibility perceived.
The nursing perception questionnaire on fundamental nursing care consists of 4 sections (evaluation for every 13 fundamental needs in terms of importance recognized by organization and nurses, frequency of implementation, degree of responsibility perceived, need to have advanced competencies). The tool uses a five-point Likert scale and yes/no answers.
Measured: perception of FoCs data will be collected at 3 time points: "baseline, before FoC framework training of trainers"; immediately after FoC framework training of trainers, immediately after the end of students' internship.
Change of perception of nursing students about how nursing student learn the fundamentals of care
Skills acquired on fundamental of care will be assessed and how the learning process helps develop them by 'Fundamentals of Care' Learning Questionnaire - Basic Care Revised
The questionnaire consists of 46 questions and uses a 4-point Likert scale to express the degree of agreement concerning learning fundamental of care and how it was learned (lesson or internship)
Measured: Immediately after the end of students' theoretical, simulation and internship learning (complete FoC learning path). Approximately 10 months after the beginning of the study
perception of nursing students on the learning environment and supervision of FOC learning during the clinical internship
The Clinical Learning Environment, Supervision and Nurse Teacher Scale (CLES+T) scale consists of 34 statements divided into five sub-dimensions: "Pedagogical atmosphere on the ward" (nine items), "Leadership style of the ward manager" (four items), "Premises of nursing on the ward" (four items), "Supervisory relationship" (eight items) and "Role of the nurse teacher (NT)" (nine items). The CLES + T items are responded to on a 5-point Likert-type scale with higher values indicating more significant agreement with the statement.
Measured: Immediately after the end of students' internship (approximately 10 months after the beginning of the study)
perception of patients concerning to identification of fundamental needs and the responses received to these needs
Patients will be asked to complete a questionnaire to evaluate:
- the perception of fundamental needs present during the hospitalization;
- identification of fundamental needs, indicated as being present by the patients, by the students during their internship;
- effectiveness of interventions implemented by the clinical-care team to respond of fundamental needs indicated by patients The patient FoC outcomes questionnaire consists of 12 questions divided into five sub-dimensions: "Communication and education", "relationship", "Nutrition and hydration" , "Elimination" and "Personal hygiene and clothing" . The patient FoC outcomes items are responded to on a 4-point Likert-type scale.
Measured: During the students internship, at the end of hospitalization, immediately before discharge from the hospital (approximately 10 months after the beginning of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Nursing StudentsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Students participating in the study will be randomly assigned to two groups: 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milko Zanini, University of Genova
- Investigators
- Annamaria Bagnasco, Prof, Principal investigator, Department of Health Sciences, University of Genoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177627
- Sponsor's protocol ID
- FoC-FORM 2021
- Acronym
- FoC-FORM
- Status last verified
- Dec 2021
- First submitted
- 13 Oct 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20649678Feo 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.
PubMed 27045560Bagnasco 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.
PubMed 28599196Feo 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.
PubMed 28271761Feo 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.
PubMed 28378679Huisman-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.
PubMed 29399907Voldbjerg 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.
PubMed 29575165Saarikoski 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.
PubMed 19232789Bagnasco 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. 2026 Apr;82(4):3449-3463. doi: 10.1111/jan.70099. Epub 2025 Jul 28.
PubMed 40726058
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating the Fundamentals of Care Framework Into Italian Nursing Education
- ClinicalTrials.gov ID
- NCT05177627
- Acronym / sponsor ID
- FoC-FORM / FoC-FORM 2021
- Conditions
- Nursing Students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 4 Jan 2022 (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.
Research has shown a gap in what is important to patients and what is important to nurses when providing care. When the patient's fundamental needs are not recognized, such as hygiene, nutrition, mobilization, communication, he feels humiliated, ignored. The study aims to improve patient outcomes by educational interventions to integrate the Fundamental of Care (FoC) framework into nursing education.
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.
Detailed description
Background and Significance: Since 2010, to fill the gap in what is essential when providing care in a complex and challenging environment, both for patients and nurses, a line of research has developed to study the fundamental of nursing care. The "Fundamentals of Care (FoC) Frameworks" defines FoC as fundamental activities for the patient, through which the patient feels at the centre of care and feels attention and respect around him. The framework outlines three dimensions necessary for delivering high-quality fundamental care: the nurse-patient relationship; addressing different fundamental needs; and a context that supports these goals. A positive and trusting nurse-patient relationship is the basis for delivering fundamental care and forms the core of the framework.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Students participating in the study will be randomly assigned to two groups: 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.
| Arm | Type | Receives |
|---|---|---|
| Fundamental of Care Framework implementation | Experimental | Other: Theoretical and classroom learning interventions, Other: Simulation interventions, Other: Internship interventionsEducational 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. |
| No Fundamental of Care Framework implementation | No intervention | –the participants of no intervention group will receive the standard training as scheduled on the curriculum |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All students of nursing degree enrolled in the first year of the course who will choose to participate in the study
- 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.
Key exclusion criteria (1 listed)
- Patients who are unable to answer the questionnaire independently, with altered mental status, with hospitalization of fewer than 24 hours
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 |
|---|---|---|
| Theoretical and classroom learning interventionsaim 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 | Other | Fundamental of Care Framework implementation |
| Simulation interventionsaim 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 | Other | Fundamental of Care Framework implementation |
| Internship interventionsAim 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. | Other | Fundamental of Care Framework implementation |
Primary outcome
technical and relational FOC based performance of students after simulation.
Time frame: At the end of simulation learning. (approximately 7 months after the beginning of the study)
Technical and relational performance acquired on fundamental of care will be assessed by Objective Clinical Structured Examination (OSCE). Scenarios built ad hoc for applying the FoC conceptual framework will be used as an evaluation test. Checklists will be used for the assessment of technical skills and observation grids to assess communication skills. The student communication performance will be evaluated using a validated assessment grid (Guilbert, 1990), which consist of four variables (i.e., terminology, listening, attention, and clarity), broken down into five levels of expected, observable communicative behaviours. Values between -2 and +2 will be used to evaluate every variable. Checklists consist of a list of tasks. Each task will be evaluated with a score of 0 if not performed or performed incorrectly, with a score of 1 if performed correctly. The passing score is 80% of the tasks performed correctly.
technical and relational FOC based performance of students after internship.
Time frame: At the end of internship learning. (approximately 10 months after the beginning of the study)
Technical and relational performance acquired on fundamental of care will be assessed by Objective Clinical Structured Examination (OSCE). Scenarios built ad hoc for applying the FoC conceptual framework will be used as an evaluation test. Checklists will be used for the assessment of technical skills and observation grids to assess communication skills. The student communication performance will be evaluated using a validated assessment grid (Guilbert, 1990), which consist of four variables (i.e., terminology, listening, attention, and clarity), broken down into five levels of expected, observable communicative behaviours. Values between -2 and +2 will be used to evaluate every variable. Checklists consist of a list of tasks. Each task will be evaluated with a score of 0 if not performed or performed incorrectly, with a score of 1 if performed correctly. The passing score is 80% of the tasks performed correctly.
4 secondary outcomes
Change of perception of fundamental of care by nurses, internship preceptors and students
Time frame: perception of FoCs data will be collected at 3 time points: "baseline, before FoC framework training of trainers"; immediately after FoC framework training of trainers, immediately after the end of students' internship.
Change of perception of nursing students about how nursing student learn the fundamentals of care
Time frame: Immediately after the end of students' theoretical, simulation and internship learning (complete FoC learning path). Approximately 10 months after the beginning of the study
perception of nursing students on the learning environment and supervision of FOC learning during the clinical internship
Time frame: Immediately after the end of students' internship (approximately 10 months after the beginning of the study)
perception of patients concerning to identification of fundamental needs and the responses received to these needs
Time frame: During the students internship, at the end of hospitalization, immediately before discharge from the hospital (approximately 10 months after the beginning of the study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Background: PubMed 20649678Kitson 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.
- Background: PubMed 27045560Feo 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.
- Background: PubMed 28599196Bagnasco 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.
- Background: PubMed 28271761Feo 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.
- Background: PubMed 28378679Feo 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.
- Background: PubMed 29399907Huisman-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.
- Background: PubMed 29575165Voldbjerg 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.
- Background: PubMed 19232789Saarikoski 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.
- Derived from this study: PubMed 40726058Bagnasco 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. 2026 Apr;82(4):3449-3463. doi: 10.1111/jan.70099. Epub 2025 Jul 28.
- Individual participant dataSharing planned: No
Related trials for Nursing Students
Not yet recruiting
The Effectiveness of Comic-based Learning Materials on Nursing Students' Knowledge, Attitudes, and Confidence in Dementia Care
Dementia Care Education, Students, Nursing
Not yet recruitingObservational study
AI-Based Model for Predicting Type 2 Diabetes Risk Using Lifestyle Factors Among Senior Nursing Students
Type 2 Diabetes Mellitus
Not yet recruiting
SELF-ASSESSMENT AND KNOWLEDGE LEVEL OF NURSING STUDENTS' PATIENT SAFETY COMPETENCY
Simulation Training, Nursing Education
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
The Effect of Happiness Workshops on Nursing Students' Levels of Psychological Resilience
Psychological Resilience, Nursing Students
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. This study is not recruiting at the moment.
Annamaria Bagnasco, Prof principal investigator
Department of Health Sciences, University of Genoa
Questions about this trial
What is this clinical trial studying?
A study testing Theoretical and classroom learning interventions, Simulation interventions and Internship interventions in people with Nursing Students, run by University of Genova.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianluca Catania, Dr (00390103538485, gianluca.catania@edu.unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical and relational FOC based performance of students after simulation. (time frame: At the end of simulation learning. (approximately 7 months after the beginning of the study)). The study lists 2 primary outcomes in all. 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 NCT05177627, which also lists 9 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 4 Jan 2022.