Problem-solvingNCT05111327
Skills Learning and Self-confidence in Learning in High-fidelity Simulation
A study testing Structured guideline in people with Problem-solving and Clinical Reasoning, run by Tung Wah College at 1 site in Hong Kong.
Trial summary
High-fidelity simulation (HFS) has become a favorable innovative teaching-learning method to facilitate students' learning in professional development in nursing. During the simulation, a variety of skills can be improved through HFS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Problem-solving, Clinical Reasoning, Satisfaction
- What is being tested?
- Structured guideline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2021to 31 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- are undergraduate nursing students
- aged 18 or above
Who cannot join
- are enrolled in the courses with high-fidelity simulation
- Have had clinical placement
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Florence MF Wong
Kowloon, 000
Florence MF Wong, DN, MN, RN, 34686838, florencewong@twc.edu.hk
Florence MF Wong, DN, MN, RN
About this study
Official title: Skill Learning Abilities and Students' Self-confidence in Learning in High-fidelity Simulation: A Mixed Method
High-fidelity simulation (HFS) has become a favorable innovative teaching-learning method to facilitate students' learning in professional development in nursing. During the simulation, a variety of skills can be improved through HFS. This mixed randomized-control and qualitative study aims to examine the effects of the structured HFS guideline on PS, CR and Student Satisfaction and Self-Confidence in Learning in undergraduate nursing students and understand their learning experience in HFS.
Read the detailed description
Nurses are facing new challenges of immediate clinical management for safer and higher quality of patient care in the current practice (Levette - Jones et al. 2018). Students are required to have independent learning and higher-intellectual skills, including problem-solving (PS) and clinical reasoning (CR), for pursuing better clinical judgements and decision-making and the most cost-effective practice (Levette - Jones et al. 2018). High-fidelity simulation (HFS) is one of the innovative and effective methods that allow students to apply integrated knowledge and skills in a designed simulated case scenario to develop higher-intellectual skills (Linn et al., 2012) and self-confidence. To allow students to achieve their HFS with enhancement of skill development and self-confidence in learning, a structured guideline is useful. This structured guideline can help course coordinators to maintain consistence in simulation teaching. Therefore, this study aims to understand students' skill development and self- confidence in learning through the HFS.
- Conditions
- Problem-solving, Clinical Reasoning, Satisfaction
- Being tested
- Structured guideline
- Keywords
- Problem-solving, clinical reasoning, student satisfaction, clinical reasoning, student satisfaction, high-fidelity simulation, nursing education
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured guidelineOther
Students in the intervention group will receive more learning materials before study. The structured guideline will be used to facilitate students' learning in simulation by the facilitator.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Students in the interventional groups will receive structured simulation guideline Receives: Other: Structured guideline |
| Control | No intervention | Students in the control groups will receive standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Problem-solving skills
Problem-solving Inventory (PSI) It consists of 32 items with a six-point Likert scale. The PSI includes three subscales: Problem-Solving Confidence (PSC) (11 items), Approach-Avoidance Style (AAS) (16 items) and Personal Control (PC) (5 items). PSC is to assess self-perceived confidence, belief and self-assurance effectively in solving problems. AAS is to measure an individual's tendency of response to approach or avoid problems. PC is to assess elements of self-control on emotions and behavior.
Measured: 6 months
Nurses' Clinical Reasoning
Nurses' Clinical Reasoning Scale (NCRS) includes 15 items with a Likert five-point scale to assess students' CR competence. Higher scores indicate higher clinical reasoning competence.
Measured: 6 months
Student Satisfaction and Self-Confidence in Learning
The Student Satisfaction and Self-Confidence in Learning consists of 13 items with 5-likert scales to measure students' perception of their satisfaction and self-confidence in learning. Five items are related to students' satisfaction in simulation-based learning activities and the remaining eight items concerns self-confidence in learning.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Nov 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Problem-solvingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Students will be randomly assigned in either interventional group or control group. There are two facilitators. Each facilitator will be consistently responsible for either interventional group or control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tung Wah College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WONG Mei Fung Florence, Tung Wah College
- Investigators
- Florence MF Wong, Doctoral, Principal investigator, Tung Wah College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111327
- Sponsor's protocol ID
- REC2021102
- Status last verified
- Feb 2022
- First submitted
- 28 Oct 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is no plan to share IPD due to confidential data.
Publications
Cadorin L, Rei A, Dante A, Bulfone T, Viera G, Palese A. Enhancing self-directed learning among Italian nursing students: A pre- and post-intervention study. Nurse Educ Today. 2015 Jun;35(6):746-53. doi: 10.1016/j.nedt.2015.02.004. Epub 2015 Feb 18.
PubMed 25735910Heppner, P.P. & Petersen, C.H. The development and implications of a personal problem solving inventory. Journal of Counseling Psychology. 1982; 29: 66-75.
Linn A, Khaw C, Kildea H, Tonkin A. Clinical reasoning - a guide to improving teaching and practice. Aust Fam Physician. 2012 Jan-Feb;41(1-2):18-20.
PubMed 22276278Liou SR, Liu HC, Tsai HM, Tsai YH, Lin YC, Chang CH, Cheng CY. The development and psychometric testing of a theory-based instrument to evaluate nurses' perception of clinical reasoning competence. J Adv Nurs. 2016 Mar;72(3):707-17. doi: 10.1111/jan.12831. Epub 2015 Oct 12.
PubMed 26455724Levett-Jones, T. (2nd Ed.). Clinical reasoning: Learning to think like a nurse. 2018. Pearson.
National League for Nursing. Description of available tools. 2016. Retrieved from http://www.nln.org/professional-development-programs/research/tools-andinstruments/descriptions-of-available-instruments
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skill Learning Abilities and Students' Self-confidence in Learning in High-fidelity Simulation: A Mixed Method
- ClinicalTrials.gov ID
- NCT05111327
- Acronym / sponsor ID
- REC2021102
- Conditions
- Problem-solving, Clinical Reasoning, Satisfaction
- Keywords
- Problem-solving, clinical reasoning, student satisfaction, clinical reasoning, student satisfaction, high-fidelity simulation, nursing education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tung Wah CollegeUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 8 Nov 2021 (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.
High-fidelity simulation (HFS) has become a favorable innovative teaching-learning method to facilitate students' learning in professional development in nursing. During the simulation, a variety of skills can be improved through HFS. This mixed randomized-control and qualitative study aims to examine the effects of the structured HFS guideline on PS, CR and Student Satisfaction and Self-Confidence in Learning in undergraduate nursing students and understand their learning experience in HFS.
Detailed description
Nurses are facing new challenges of immediate clinical management for safer and higher quality of patient care in the current practice (Levette - Jones et al. 2018). Students are required to have independent learning and higher-intellectual skills, including problem-solving (PS) and clinical reasoning (CR), for pursuing better clinical judgements and decision-making and the most cost-effective practice (Levette - Jones et al. 2018). High-fidelity simulation (HFS) is one of the innovative and effective methods that allow students to apply integrated knowledge and skills in a designed simulated case scenario to develop higher-intellectual skills (Linn et al., 2012) and self-confidence. To allow students to achieve their HFS with enhancement of skill development and self-confidence in learning, a structured guideline is useful. This structured guideline can help course coordinators to maintain consistence in simulation teaching. Therefore, this study aims to understand students' skill development and self- confidence in learning through the HFS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Students will be randomly assigned in either interventional group or control group. There are two facilitators. Each facilitator will be consistently responsible for either interventional group or control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Structured guidelineStudents in the interventional groups will receive structured simulation guideline |
| Control | No intervention | –Students in the control groups will receive standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- are undergraduate nursing students
- aged 18 or above
Key exclusion criteria (2 listed)
- are enrolled in the courses with high-fidelity simulation
- Have had clinical placement
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 |
|---|---|---|
| Structured guidelineStudents in the intervention group will receive more learning materials before study. The structured guideline will be used to facilitate students' learning in simulation by the facilitator. | Other | Intervention |
Primary outcome
Problem-solving skills
Time frame: 6 months
Problem-solving Inventory (PSI) It consists of 32 items with a six-point Likert scale. The PSI includes three subscales: Problem-Solving Confidence (PSC) (11 items), Approach-Avoidance Style (AAS) (16 items) and Personal Control (PC) (5 items). PSC is to assess self-perceived confidence, belief and self-assurance effectively in solving problems. AAS is to measure an individual's tendency of response to approach or avoid problems. PC is to assess elements of self-control on emotions and behavior.
Nurses' Clinical Reasoning
Time frame: 6 months
Nurses' Clinical Reasoning Scale (NCRS) includes 15 items with a Likert five-point scale to assess students' CR competence. Higher scores indicate higher clinical reasoning competence.
Student Satisfaction and Self-Confidence in Learning
Time frame: 6 months
The Student Satisfaction and Self-Confidence in Learning consists of 13 items with 5-likert scales to measure students' perception of their satisfaction and self-confidence in learning. Five items are related to students' satisfaction in simulation-based learning activities and the remaining eight items concerns self-confidence in learning.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Background: PubMed 25735910Cadorin L, Rei A, Dante A, Bulfone T, Viera G, Palese A. Enhancing self-directed learning among Italian nursing students: A pre- and post-intervention study. Nurse Educ Today. 2015 Jun;35(6):746-53. doi: 10.1016/j.nedt.2015.02.004. Epub 2015 Feb 18.
- BackgroundHeppner, P.P. & Petersen, C.H. The development and implications of a personal problem solving inventory. Journal of Counseling Psychology. 1982; 29: 66-75.
- Background: PubMed 22276278Linn A, Khaw C, Kildea H, Tonkin A. Clinical reasoning - a guide to improving teaching and practice. Aust Fam Physician. 2012 Jan-Feb;41(1-2):18-20.
- Background: PubMed 26455724Liou SR, Liu HC, Tsai HM, Tsai YH, Lin YC, Chang CH, Cheng CY. The development and psychometric testing of a theory-based instrument to evaluate nurses' perception of clinical reasoning competence. J Adv Nurs. 2016 Mar;72(3):707-17. doi: 10.1111/jan.12831. Epub 2015 Oct 12.
- BackgroundLevett-Jones, T. (2nd Ed.). Clinical reasoning: Learning to think like a nurse. 2018. Pearson.
- BackgroundNational League for Nursing. Description of available tools. 2016. Retrieved from http://www.nln.org/professional-development-programs/research/tools-andinstruments/descriptions-of-available-instruments
- Individual participant dataSharing planned: Yes. There is no plan to share IPD due to confidential data.
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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.
Florence MF Wong, Doctoral principal investigator
Tung Wah College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured guideline in people with Problem-solving and Clinical Reasoning, run by Tung Wah College at 1 site in Hong Kong.
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 2 inclusion and 2 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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 David Wong, PhD ((852) 31906722, florencewong@twc.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Problem-solving skills (time frame: 6 months). The study lists 3 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 NCT05111327, which also lists 6 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 8 Mar 2022.