AnxietyNCT05668273
Patient Assessment, and Anxiety and Self-Confidence With Clinical Decision Making in Auscultation Skills With Simulation
A study testing education with simulated patient and education with simulator in people with Anxiety and Self-Confidence, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This research is a randomized controlled experimental design. This research will be applied within the scope of the Health Assessment Course. The population of the research will be the students enrolled in the Health Assessment Course (n=138). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Self-Confidence
- What is being tested?
- education with simulated patient and education with simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2022to 6 Jul 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
- Enrolling in the Health Assessment Course for the first time
- Volunteering to participate in research
Who cannot join
- Having a high school, associate, or undergraduate degree in a health-related field,
- Take a previous course in health assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Simulation in the Teaching of Auscultation Skills on Patient Assessment, and Anxiety and Self-Confidence With Clinical Decision Making
This research is a randomized controlled experimental design. This research will be applied within the scope of the Health Assessment Course. The population of the research will be the students enrolled in the Health Assessment Course (n=138). The sample will consist of students who volunteered to participate in the research.
Introductory Specifications Form, Nursing Anxiety and Self-Confidence with Clinical Decision-Making scale, Auscultation of Heart, Lung, and Bowel Sounds Checklist, and Opinions of Students about the Auscultation Skills Training will be used in the implementation of the research.
Permission was obtained from the Gazi University Ethics Committee and the Dean of the Faculty of Health Sciences to conduct the research. Informed consent will be obtained from the students who will participate in the research.
Read the detailed description
This research will be applied within the scope of the Health Assessment Course in Gazi University Faculty of Nursing in the fall and spring semesters of the 2022-2023 academic year. The population of the research will be the students enrolled in the Health Assessment Course (n=138). The sample will consist of students who volunteered to participate in the research.
Introductory Specifications Form, Nursing Anxiety and Self-Confidence with Clinical Decision-Making scale, Auscultation of Heart, Lung, and Bowel Sounds Checklist, and Opinions of Students about the Auscultation Skills Training will be used in the implementation of the research.
The researcher will teach all students the theoretical content of the subject. The students who meet the criteria for inclusion in the research will then be given the Introductory Specifications Form and the Nursing Anxiety and Self-Confidence with Clinical Decision-Making scale (pre-test). Students will be divided into three groups based on their academic averages and scale scores using stratified randomization. Students in experimental group 1 will be trained with a standardized patient, students in experimental group 2 will be trained with a high-fidelity simulator, and students in the control group will be trained with their peers. Following the completion of the application, the students will participate in a debriefing session. Students will be evaluated using checklists one week after submitting their applications. At this point, students in experimental group 1 will practice auscultation of heart, lung, and bowel sounds on a standardized patient, students in experimental group 2 will practice on a high-fidelity simulator, and students in the control group will practice on their peers.
While the students are applying, the observers will fill out the checklist for each item from the "observed," "incorrect/incomplete," and "not observed" options. Following the application, students will complete the Nursing Anxiety and Self-Confidence with Clinical Decision-Making scale (post-test).
During the spring semester, students will participate in clinical practice at various clinics two days per week as part of the Surgical Nursing Course. They also use auscultation skills in clinical settings. Students in the Experimental 1, Experimental 2, and Control groups will complete the Nursing Anxiety and Self-Confidence with Clinical Decision-Making scale and Opinions of Students about the Auscultation Skills Training at the end of the spring semester (when clinical applications are completed) (follow-up test).
Permission was obtained from the Gazi University Ethics Committee and the Dean of the Faculty of Health Sciences to conduct the research. Informed consent will be obtained from the students who will participate in the research.
The quantitative data from this study will be digitized in the SPSS package program, and the necessary statistical analyses will be performed.
- Conditions
- Anxiety, Self-Confidence
- Being tested
- education with simulated patient, education with simulator, control group
- Keywords
- Simulation, Nursing, Auscultation, Patient assessment
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education with simulated patientOther
Students in the education with the simulated patient group will practice auscultation skills on the simulated patient with heart, lung, and bowel sounds. There will be a lecturer at the head of the group who will provide the necessary coordination. A debriefing session will be held with the students by the educator right after the students have finished the application.
education with simulatorOther
Students in the simulator group will practice auscultation skills on high fidelity simulator with heart, lung, and bowel sounds. There will be a lecturer at the head of the group who will provide the necessary coordination. A debriefing session will be held with the students by the educator right after the students have finished the application.
control groupOther
Students in the control group will practice auscultation skills on their peers with heart, lung, and bowel sounds. There will be a lecturer at the head of the group who will provide the necessary coordination.
| Study group | Role | What they receive |
|---|---|---|
| education with simulated patient | Experimental | Participants will be given training on auscultation skills with a simulated patient. Receives: Other: education with simulated patient |
| education with simulator | Experimental | Participants will be given training on auscultation skills with a simulation. Receives: Other: education with simulator |
| control group | Active comparator | Participants will be given training on auscultation skills with their peer students. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of the Nursing Anxiety and Self-Confidence with Clinical Decision-Making
This scale consists of 27 questions. Separate scores are obtained for self-confidence and anxiety from the scale. For both self-confidence and anxiety sections of the scale; It has three sub-dimensions: "Using resources to obtain information and listening fully (13 questions)", "Using the information at hand to determine the problem (7 questions)" and "knowing and acting (7 questions)". As the scores obtained from the self-confidence section and its sub-dimensions increase, the self-confidence level of the student increases, and the low scores obtained from the anxiety section and its sub-dimensions indicate a low level of anxiety. In the scale prepared in a six-point likert type; The lowest score that can be obtained from the self-confidence and anxiety sections is 27, and the highest score is 162.
Measured: 5 months
Auscultation of Heart, Lung and Bowel Sounds Checklist
The checklist has been prepared in line with the objectives of the course content on heart, lung and bowel sounds. It consists of application steps that include the process steps in detail. It was created in the form of a rubric in order to observe the students objectively. Each item in the checklist has different scores according to its importance. The total score to be taken from all of them is 50. Expert opinion of the checklist was taken by 5 faculty members who are experts in the field.
Measured: One week
Secondary outcomes (1)
Opinions of students about the auscultation skills training
The form will be used in order to learn the reflection of auscultation skills education in clinical practice. The interview questions in the form were created in line with the academic experiences of the researchers. The interview form consists of 3 open-ended questions: 1) how the training affected their feelings and thoughts in clinical practice, 2) how it affected their application of physical examination skills for the patients they care for in the clinic, and 3) what would have changed if you had gone to the clinic without this training. This form will be evaluated by thematic analysis.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start5 Dec 2022
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- This research is a randomized controlled experimental design.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evrim Eyikara, Gazi University
- Investigators
- Nurcan Çalışkan, Prof., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668273
- Sponsor's protocol ID
- GaziU-SBF-SA-2
- Status last verified
- Aug 2023
- First submitted
- 12 Dec 2022
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Publications
Bektaş, İ., Yardımcı, F., Bektaş, M., & White, K. A. (2017). Psychometric properties of the Turkish version of nursing anxiety and self-confidence with clinical decision-making scale (NASC-CDM-T). Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 10(2), 83-92.
Gawlik, K.S., Melnyk, B.M., Teall, A.M. (Eds.), (2022), Evidence-based physical examination handbook, Springer Publishing Company, LLC
Hogan-Quigley, B., Palm, M.L., Bickley, L.S., (2012). Bates' nursing guide to physical examination and history taking. Wolters Kluwer Health | Lippincott Williams & Wilkins.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation in the Teaching of Auscultation Skills on Patient Assessment, and Anxiety and Self-Confidence With Clinical Decision Making
- ClinicalTrials.gov ID
- NCT05668273
- Acronym / sponsor ID
- GaziU-SBF-SA-2
- Conditions
- Anxiety, Self-Confidence
- Keywords
- Simulation, Nursing, Auscultation, Patient assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 29 Dec 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.
This research is a randomized controlled experimental design. This research will be applied within the scope of the Health Assessment Course. The population of the research will be the students enrolled in the Health Assessment Course (n=138). The sample will consist of students who volunteered to participate in the research.
Introductory Specifications Form, Nursing Anxiety and Self-Confidence with Clinical Decision-Making scale, Auscultation of Heart, Lung, and Bowel Sounds Checklist, and Opinions of Students about the Auscultation Skills Training will be used in the implementation of the research.
Permission was obtained from the Gazi University Ethics Committee and the Dean of the Faculty of Health Sciences to conduct the research. Informed consent will be obtained from the students who will participate in the research.
Detailed description
This research will be applied within the scope of the Health Assessment Course in Gazi University Faculty of Nursing in the fall and spring semesters of the 2022-2023 academic year. The population of the research will be the students enrolled in the Health Assessment Course (n=138). The sample will consist of students who volunteered to participate in the research.
Introductory Specifications Form, Nursing Anxiety and Self-Confidence with Clinical Decision-Making scale, Auscultation of Heart, Lung, and Bowel Sounds Checklist, and Opinions of Students about the Auscultation Skills Training will be used in the implementation of the research.
The researcher will teach all students the theoretical content of the subject. The students who meet the criteria for inclusion in the research will then be given the Introductory Specifications Form and the Nursing Anxiety and Self-Confidence with Clinical Decision-Making scale (pre-test). Students will be divided into three groups based on their academic averages and scale scores using stratified randomization. Students in experimental group 1 will be trained with a standardized patient, students in experimental group 2 will be trained with a high-fidelity simulator, and students in the control group will be trained with their peers. Following the completion of the application, the students will participate in a debriefing session. Students will be evaluated using checklists one week after submitting their applications. At this point, students in experimental group 1 will practice auscultation of heart, lung, and bowel sounds on a standardized patient, students in experimental group 2 will practice on a high-fidelity simulator, and students in the control group will practice on their peers.
While the students are applying, the observers will fill out the checklist for each item from the "observed," "incorrect/incomplete," and "not observed" options. Following the application, students will complete the Nursing Anxiety and Self-Confidence with Clinical Decision-Making scale (post-test).
During the spring semester, students will participate in clinical practice at various clinics two days per week as part of the Surgical Nursing Course. They also use auscultation skills in clinical settings. Students in the Experimental 1, Experimental 2, and Control groups will complete the Nursing Anxiety and Self-Confidence with Clinical Decision-Making scale and Opinions of Students about the Auscultation Skills Training at the end of the spring semester (when clinical applications are completed) (follow-up test).
Permission was obtained from the Gazi University Ethics Committee and the Dean of the Faculty of Health Sciences to conduct the research. Informed consent will be obtained from the students who will participate in the research.
The quantitative data from this study will be digitized in the SPSS package program, and the necessary statistical analyses will be performed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This research is a randomized controlled experimental design.
| Arm | Type | Receives |
|---|---|---|
| education with simulated patient | Experimental | Other: education with simulated patientParticipants will be given training on auscultation skills with a simulated patient. |
| education with simulator | Experimental | Other: education with simulatorParticipants will be given training on auscultation skills with a simulation. |
| control group | Active comparator | Other: control groupParticipants will be given training on auscultation skills with their peer students. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Enrolling in the Health Assessment Course for the first time
- Volunteering to participate in research
Key exclusion criteria (2 listed)
- Having a high school, associate, or undergraduate degree in a health-related field,
- Take a previous course in health assessment
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 |
|---|---|---|
| education with simulated patientStudents in the education with the simulated patient group will practice auscultation skills on the simulated patient with heart, lung, and bowel sounds. There will be a lecturer at the head of the group who will provide the necessary coordination. A debriefing session will be held with the students by the educator right after the students have finished the application. | Other | education with simulated patient |
| education with simulatorStudents in the simulator group will practice auscultation skills on high fidelity simulator with heart, lung, and bowel sounds. There will be a lecturer at the head of the group who will provide the necessary coordination. A debriefing session will be held with the students by the educator right after the students have finished the application. | Other | education with simulator |
| control groupStudents in the control group will practice auscultation skills on their peers with heart, lung, and bowel sounds. There will be a lecturer at the head of the group who will provide the necessary coordination. | Other | control group |
Primary outcome
The Change of the Nursing Anxiety and Self-Confidence with Clinical Decision-Making
Time frame: 5 months
This scale consists of 27 questions. Separate scores are obtained for self-confidence and anxiety from the scale. For both self-confidence and anxiety sections of the scale; It has three sub-dimensions: "Using resources to obtain information and listening fully (13 questions)", "Using the information at hand to determine the problem (7 questions)" and "knowing and acting (7 questions)". As the scores obtained from the self-confidence section and its sub-dimensions increase, the self-confidence level of the student increases, and the low scores obtained from the anxiety section and its sub-dimensions indicate a low level of anxiety. In the scale prepared in a six-point likert type; The lowest score that can be obtained from the self-confidence and anxiety sections is 27, and the highest score is 162.
Auscultation of Heart, Lung and Bowel Sounds Checklist
Time frame: One week
The checklist has been prepared in line with the objectives of the course content on heart, lung and bowel sounds. It consists of application steps that include the process steps in detail. It was created in the form of a rubric in order to observe the students objectively. Each item in the checklist has different scores according to its importance. The total score to be taken from all of them is 50. Expert opinion of the checklist was taken by 5 faculty members who are experts in the field.
1 secondary outcome
Opinions of students about the auscultation skills training
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- BackgroundBektaş, İ., Yardımcı, F., Bektaş, M., & White, K. A. (2017). Psychometric properties of the Turkish version of nursing anxiety and self-confidence with clinical decision-making scale (NASC-CDM-T). Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 10(2), 83-92.
- BackgroundGawlik, K.S., Melnyk, B.M., Teall, A.M. (Eds.), (2022), Evidence-based physical examination handbook, Springer Publishing Company, LLC
- BackgroundHogan-Quigley, B., Palm, M.L., Bickley, L.S., (2012). Bates' nursing guide to physical examination and history taking. Wolters Kluwer Health | Lippincott Williams & Wilkins.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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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.
Nurcan Çalışkan, Prof. study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education with simulated patient and education with simulator in people with Anxiety and Self-Confidence, run by Gazi University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 23 Aug 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change of the Nursing Anxiety and Self-Confidence with Clinical Decision-Making (time frame: 5 months). 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 NCT05668273, which also lists 3 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 23 Aug 2023.