Aspiration Skill Self-assessmentNCT06800235
The Effect of Computer-Aided Simulation Training on Aspiration Skills and General Efficacy Beliefs
A study testing Computer-Assisted Simulation in people with Aspiration Skill Self-assessment and General Competence Belief, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
Purpose This study was conducted to determine the effect of computer-aided simulation education on nursing students' aspiration skills and general competence beliefs. Research Hypotheses H1-1: Computer-aided simulation education has an effect on aspiration self-efficacy. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Aspiration Skill Self-assessment, General Competence Belief
- What is being tested?
- Computer-Assisted Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2024to 20 Dec 2024
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants;
- Must be enrolled in a nursing program,
- Must be a second year student,
- Must be volunteers for the study.
Who cannot join
- Participants;
- Not registered in the nursing program,
- Not being a second year student,
- Having class absences,
- Joining the department through horizontal or vertical transfer,
- Not passing the Fundamentals of Nursing course,
- Not having experienced aspiration skills on a real patient,
- Not volunteering for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Computer-Assisted Simulation Education on Aspiration Skills and General Efficacy Beliefs of Nursing Students
Purpose This study was conducted to determine the effect of computer-aided simulation education on nursing students' aspiration skills and general competence beliefs.
Research Hypotheses H1-1: Computer-aided simulation education has an effect on aspiration self-efficacy.
Read more
H1-2: Computer-aided simulation education has an effect on nursing students' general competence beliefs.
Method
Research Design The research is a randomized controlled experimental study.
Place of the Research The research was conducted with students studying in the second year of the nursing department of the faculty of health sciences of a state university in the fall semester of the 2024-2025 academic year between November 20 and December 20, 2024.
The Universe and Sample of the Study The universe of the study consisted of students studying in the second year of the nursing department of the faculty of health sciences of a state university in the fall semester of the 2024-2025 academic year (N=126). The sample consisted of second year students who met the acceptance criteria of the study. Power analysis was performed to determine the number of people to be included in the study. Power analysis was calculated with the G*Power 3.1 program in the sample calculation. The effect size was taken as 0.80 as high level according to the difference between independent groups determined by Cohen (1988). In order to exceed the 95% value in determining the power of the study; a total of 70 people should be reached, 35 in each group at a significance level of 5% and an effect size of 0.80 (df=68; t=1.668).
The students were randomly assigned to the control and intervention groups. A randomization table was created using the website http://stattrek.com/statistics/random-number-generator.aspx.
Read the detailed description
Purpose This study was conducted to determine the effect of computer-aided simulation education on nursing students' aspiration skills and general competence beliefs.
Research Hypotheses H1-1: Computer-aided simulation education has an effect on aspiration self-efficacy.
H1-2: Computer-aided simulation education has an effect on nursing students' general competence beliefs.
Method
Research Design The research is a randomized controlled experimental study.
Place of the Research The research was conducted with students studying in the second year of the nursing department of the faculty of health sciences of a state university in the fall semester of the 2024-2025 academic year between November 20 and December 20, 2024.
The Universe and Sample of the Study The universe of the study consisted of students studying in the second year of the nursing department of the faculty of health sciences of a state university in the fall semester of the 2024-2025 academic year (N=126). The sample consisted of second year students who met the acceptance criteria of the study. Power analysis was performed to determine the number of people to be included in the study. Power analysis was calculated with the G*Power 3.1 program in the sample calculation. The effect size was taken as 0.80 as high level according to the difference between independent groups determined by Cohen (1988). In order to exceed the 95% value in determining the power of the study; a total of 70 people should be reached, 35 in each group at a significance level of 5% and an effect size of 0.80 (df=68; t=1.668).
The students were randomly assigned to the control and intervention groups. A randomization table was created using the website http://stattrek.com/statistics/random-number-generator.aspx. Inclusion and Exclusion Criteria: Volunteer second-year nursing students were included in the study. Students who were absent from classes in the relevant period, who joined the department through horizontal and vertical transfer, who were unsuccessful in the Fundamentals of Nursing course, who experienced aspiration skill on a real patient, and students who did not volunteer to participate in the study will not be accepted.
Dependent, independent variables: The dependent variables of the study were determined as aspiration self-efficacy and general competence belief scale score average. Independent variables are other characteristics obtained in the student identification form (age, gender, etc.) Data Collection Tools Student Identification Form It was prepared by the researchers in line with the literature. It consists of 6 questions that include the introductory characteristics of nursing students and some information about their education (age, gender, academic grade point average, type of high school graduated, status of choosing the nursing department, status of fear of performing nursing practices).
Aspiration Skill Self-Assessment Form It was created by the researcher in order to evaluate the students' ability to perform the steps of the procedure related to aspiration application. The first form consisting of 25 items in a 5-point Likert type developed by the researchers for aspiration application skills was presented to a total of 10 experts from the field of nursing. The content validity index (CVI) of the expressions for the created items was calculated. In line with the expert opinions; adjustments were made regarding the items that were stated to be incomprehensible, had similar meanings, contained multiple judgments and would not measure the skill. In addition, the Cronbach Alpha value of the evaluation form for this study was determined as 0.882.
General Competence Belief Scale The scale to be used to measure the general competence belief of nursing students was created by Jerusalem and Schwarzer in 1992. Its adaptation to Turkish was also made by Çelik Kaleli and Çapri (2008) (Çelik Kaleli and Çapri, 2008). The scale has 10 items and a 4-point Likert type. The minimum score that can be obtained from the scale is 10, and the maximum score is 40. An increase in the score obtained by the participant indicates that the level of general competence belief also increases. The Cronbach Alpha value of the scale is 0.92. The Cronbach Alpha value of the scale for this study was obtained as 0.875.
Data Collection The data were collected by the researchers between November-December 2024. The study was started after obtaining permission from the ethics committee and the institution. At the beginning of the study, the purpose and process of the study were explained to the students and the "Informed Voluntary Consent Form" and "Student Identification Form" were filled out. After this consent, other forms were applied to the students as a pre-test. Then, the students were separated into experimental and control groups with a random number table and the education date and information were shared with the students. In the study, the control group was given standard education with a skill model and the experimental group was given education with a computer-aided simulation. The forms were applied again as a post-test after each group.
Ethical Aspect of the Study Before starting the study, approval was obtained from the Istanbul Beykent University Non-Interventional Ethics Committee (Date: 18.11.2024 and Number: 72128186/635) and institutional permission was obtained from the Tekirdağ Namık Kemal University Faculty of Health Sciences. The students were informed about the study and written consent was obtained from the students who volunteered to participate in the study. The study was conducted according to the principles of the Helsinki Declaration.
Data Evaluation The data obtained in the study were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistical methods were used in the evaluation of the data: number, percentage, mean, standard deviation. Differences between the rates of categorical variables in independent groups were analyzed with Chi-Square and Fisher exact tests. Independent groups t-test was used to compare quantitative continuous data between two independent groups. Dependent groups t-test was used to compare within-group measurements. The results were evaluated at a 95% confidence interval and significance was at p<0.05.
- Being tested
- Computer-Assisted Simulation, Control grup
- Keywords
- aspiration skill self-assessment, general competence belief, computer-based simulation, nursing practices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted SimulationOther
Nursing students in the experimental group were informed about computer-based simulation. They were also informed about the aspiration skill form and general competency scale.
Control grupOther
Nursing students in the control group were informed about the standard procedure/traditional method. They were also informed about the aspiration skill form and general competency scale.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Standard Procedure) | Other | Nursing students in the control group were informed about the standard procedure/traditional method. They were also informed about the aspiration skill form and general competency scale. Receives: Other: Control grup |
| Experimental Group | Experimental | Nursing students in the experimental group were informed about computer-based simulation. They were also informed about the aspiration skill form and general competency scale. Receives: Other: Computer-Assisted Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspiration Skill Self-Assessment score average
Nursing students were informed about the Aspiration Skill Self-Assessment Form
Measured: 1 month
General Self-Efficacy Belief Scale score average
Nursing students were informed about the general competency scale.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start20 Nov 2024
- Primary completion20 Nov 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aspiration Skill Self-assessmentStudies 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
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamiyet KIZIL, University of Beykent
- Investigators
- Hamiyet Kızıl, Phd RN, Principal investigator, Istanbul Beykent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800235
- Sponsor's protocol ID
- 635
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gülbetekin, E., & Abi, Ö. (2023). Hemşirelik öğrencilerinin mesleki beceri laboratuvarı uygulamaları öncesi ve sonrası stres ve genel yetkinlik inancı düzeyleri: Hemşirelik öğrencilerinin mesleki beceri laboratuvarı uygulamaları. Journal of Infant, Child and Adolescent Health, 3(2), 111-119.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Computer-Assisted Simulation Education on Aspiration Skills and General Efficacy Beliefs of Nursing Students
- ClinicalTrials.gov ID
- NCT06800235
- Acronym / sponsor ID
- 635
- Keywords
- aspiration skill self-assessment, general competence belief, computer-based simulation, nursing practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 29 Jan 2025 (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.
Purpose This study was conducted to determine the effect of computer-aided simulation education on nursing students' aspiration skills and general competence beliefs.
Research Hypotheses H1-1: Computer-aided simulation education has an effect on aspiration self-efficacy.
H1-2: Computer-aided simulation education has an effect on nursing students' general competence beliefs.
Method
Research Design The research is a randomized controlled experimental study.
Place of the Research The research was conducted with students studying in the second year of the nursing department of the faculty of health sciences of a state university in the fall semester of the 2024-2025 academic year between November 20 and December 20, 2024.
The Universe and Sample of the Study The universe of the study consisted of students studying in the second year of the nursing department of the faculty of health sciences of a state university in the fall semester of the 2024-2025 academic year (N=126). The sample consisted of second year students who met the acceptance criteria of the study. Power analysis was performed to determine the number of people to be included in the study. Power analysis was calculated with the G*Power 3.1 program in the sample calculation. The effect size was taken as 0.80 as high level according to the difference between independent groups determined by Cohen (1988). In order to exceed the 95% value in determining the power of the study; a total of 70 people should be reached, 35 in each group at a significance level of 5% and an effect size of 0.80 (df=68; t=1.668).
The students were randomly assigned to the control and intervention groups. A randomization table was created using the website http://stattrek.com/statistics/random-number-generator.aspx.
Detailed description
Purpose This study was conducted to determine the effect of computer-aided simulation education on nursing students' aspiration skills and general competence beliefs.
Research Hypotheses H1-1: Computer-aided simulation education has an effect on aspiration self-efficacy.
H1-2: Computer-aided simulation education has an effect on nursing students' general competence beliefs.
Method
Research Design The research is a randomized controlled experimental study.
Place of the Research The research was conducted with students studying in the second year of the nursing department of the faculty of health sciences of a state university in the fall semester of the 2024-2025 academic year between November 20 and December 20, 2024.
The Universe and Sample of the Study The universe of the study consisted of students studying in the second year of the nursing department of the faculty of health sciences of a state university in the fall semester of the 2024-2025 academic year (N=126). The sample consisted of second year students who met the acceptance criteria of the study. Power analysis was performed to determine the number of people to be included in the study. Power analysis was calculated with the G*Power 3.1 program in the sample calculation. The effect size was taken as 0.80 as high level according to the difference between independent groups determined by Cohen (1988). In order to exceed the 95% value in determining the power of the study; a total of 70 people should be reached, 35 in each group at a significance level of 5% and an effect size of 0.80 (df=68; t=1.668).
The students were randomly assigned to the control and intervention groups. A randomization table was created using the website http://stattrek.com/statistics/random-number-generator.aspx. Inclusion and Exclusion Criteria: Volunteer second-year nursing students were included in the study. Students who were absent from classes in the relevant period, who joined the department through horizontal and vertical transfer, who were unsuccessful in the Fundamentals of Nursing course, who experienced aspiration skill on a real patient, and students who did not volunteer to participate in the study will not be accepted.
Dependent, independent variables: The dependent variables of the study were determined as aspiration self-efficacy and general competence belief scale score average. Independent variables are other characteristics obtained in the student identification form (age, gender, etc.) Data Collection Tools Student Identification Form It was prepared by the researchers in line with the literature. It consists of 6 questions that include the introductory characteristics of nursing students and some information about their education (age, gender, academic grade point average, type of high school graduated, status of choosing the nursing department, status of fear of performing nursing practices).
Aspiration Skill Self-Assessment Form It was created by the researcher in order to evaluate the students' ability to perform the steps of the procedure related to aspiration application. The first form consisting of 25 items in a 5-point Likert type developed by the researchers for aspiration application skills was presented to a total of 10 experts from the field of nursing. The content validity index (CVI) of the expressions for the created items was calculated. In line with the expert opinions; adjustments were made regarding the items that were stated to be incomprehensible, had similar meanings, contained multiple judgments and would not measure the skill. In addition, the Cronbach Alpha value of the evaluation form for this study was determined as 0.882.
General Competence Belief Scale The scale to be used to measure the general competence belief of nursing students was created by Jerusalem and Schwarzer in 1992. Its adaptation to Turkish was also made by Çelik Kaleli and Çapri (2008) (Çelik Kaleli and Çapri, 2008). The scale has 10 items and a 4-point Likert type. The minimum score that can be obtained from the scale is 10, and the maximum score is 40. An increase in the score obtained by the participant indicates that the level of general competence belief also increases. The Cronbach Alpha value of the scale is 0.92. The Cronbach Alpha value of the scale for this study was obtained as 0.875.
Data Collection The data were collected by the researchers between November-December 2024. The study was started after obtaining permission from the ethics committee and the institution. At the beginning of the study, the purpose and process of the study were explained to the students and the "Informed Voluntary Consent Form" and "Student Identification Form" were filled out. After this consent, other forms were applied to the students as a pre-test. Then, the students were separated into experimental and control groups with a random number table and the education date and information were shared with the students. In the study, the control group was given standard education with a skill model and the experimental group was given education with a computer-aided simulation. The forms were applied again as a post-test after each group.
Ethical Aspect of the Study Before starting the study, approval was obtained from the Istanbul Beykent University Non-Interventional Ethics Committee (Date: 18.11.2024 and Number: 72128186/635) and institutional permission was obtained from the Tekirdağ Namık Kemal University Faculty of Health Sciences. The students were informed about the study and written consent was obtained from the students who volunteered to participate in the study. The study was conducted according to the principles of the Helsinki Declaration.
Data Evaluation The data obtained in the study were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistical methods were used in the evaluation of the data: number, percentage, mean, standard deviation. Differences between the rates of categorical variables in independent groups were analyzed with Chi-Square and Fisher exact tests. Independent groups t-test was used to compare quantitative continuous data between two independent groups. Dependent groups t-test was used to compare within-group measurements. The results were evaluated at a 95% confidence interval and significance was at p<0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (Standard Procedure) | Other | Other: Control grupNursing students in the control group were informed about the standard procedure/traditional method. They were also informed about the aspiration skill form and general competency scale. |
| Experimental Group | Experimental | Other: Computer-Assisted SimulationNursing students in the experimental group were informed about computer-based simulation. They were also informed about the aspiration skill form and general competency scale. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants;
- Must be enrolled in a nursing program,
- Must be a second year student,
- Must be volunteers for the study.
Key exclusion criteria (8 listed)
- Participants;
- Not registered in the nursing program,
- Not being a second year student,
- Having class absences,
- Joining the department through horizontal or vertical transfer,
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 |
|---|---|---|
| Computer-Assisted SimulationNursing students in the experimental group were informed about computer-based simulation. They were also informed about the aspiration skill form and general competency scale. | Other | Experimental Group |
| Control grupNursing students in the control group were informed about the standard procedure/traditional method. They were also informed about the aspiration skill form and general competency scale. | Other | Control Group (Standard Procedure) |
Primary outcome
Aspiration Skill Self-Assessment score average
Time frame: 1 month
Nursing students were informed about the Aspiration Skill Self-Assessment Form
General Self-Efficacy Belief Scale score average
Time frame: 1 month
Nursing students were informed about the general competency scale.
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 29 Jan 2025.
- Results publicationGülbetekin, E., & Abi, Ö. (2023). Hemşirelik öğrencilerinin mesleki beceri laboratuvarı uygulamaları öncesi ve sonrası stres ve genel yetkinlik inancı düzeyleri: Hemşirelik öğrencilerinin mesleki beceri laboratuvarı uygulamaları. Journal of Infant, Child and Adolescent Health, 3(2), 111-119.
- Individual participant dataSharing planned: No
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.
Hamiyet Kızıl, Phd RN principal investigator
Istanbul Beykent 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 Computer-Assisted Simulation in people with Aspiration Skill Self-assessment and General Competence Belief, run by University of Beykent 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 4 inclusion and 8 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 29 Jan 2025. 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?
Aspiration Skill Self-Assessment score average (time frame: 1 month). 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 NCT06800235, which also lists 1 linked publication.
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 29 Jan 2025.