- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06800235
The Effect of Computer-Aided Simulation Training on Aspiration Skills and General Efficacy Beliefs
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.
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Hamiyet Kızıl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants;
- Must be enrolled in a nursing program,
- Must be a second year student,
- Must be volunteers for the study.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control Group (Standard Procedure)
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.
|
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.
|
|
Experimental: Experimental Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aspiration Skill Self-Assessment score average
Time Frame: 1 month
|
Nursing students were informed about the Aspiration Skill Self-Assessment Form
|
1 month
|
|
General Self-Efficacy Belief Scale score average
Time Frame: 1 month
|
Nursing students were informed about the general competency scale.
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hamiyet Kızıl, Phd RN, Istanbul Beykent University
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 635
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aspiration Skill Self-assessment
-
George Mason UniversityNational Institute on Drug Abuse (NIDA); University of MarylandCompletedSkill Development of Staff | Use of Standardized Assessment ToolsUnited States
-
Texas A&M UniversityCompletedSelf-Perception | Self-Assessment
-
University Hospital Inselspital, BerneCompletedSelf-AssessmentSwitzerland
-
Johannes Kepler University of LinzMedical University of Graz; FH Joanneum Gesellschaft mbH; Kepler University HospitalNot yet recruitingPerception, Self | Self-Assessment | Body Awareness
-
Johannes Kepler University of LinzMedical University of GrazCompleted
-
Johannes Kepler University of LinzMedical University of GrazCompleted
-
AdventHealthUniversity of South Florida; Yale University; Beth Israel Deaconess Medical Center and other collaboratorsActive, not recruitingAssessment, Self | CompetenceUnited States
-
Istanbul University - CerrahpasaCompletedHealthy | Assessment, SelfTurkey (Türkiye)
-
Technical University of MunichCharite University, Berlin, Germany; Translationales intensivmedizinisches...CompletedCritical Illness | Assessment, Self | Self-AssessmentGermany
Clinical Trials on Control grup
-
Erzincan Binali Yildirim UniversitesiNot yet recruitingMigrants | eHealth Literacy | Digital Literacy
-
Saglik Bilimleri UniversitesiActive, not recruitingBreastfeeding | Training Group, Sensitivity | High Fidelity Simulation Training | Medical Simulation | Standardized PatientTurkey
-
Istanbul Aydın UniversityCompletedMultiple SclerosisTurkey
-
Instituto Materno Infantil Prof. Fernando FigueiraCompleted
-
Cumhuriyet UniversityCompletedInfection | Intensive Care | Nurses Role | Patient CareTurkey
-
Eskisehir Osmangazi UniversityCompletedInterventions PainTurkey
-
Medipol UniversityNot yet recruiting
-
Acıbadem Atunizade HospitalCompletedUpper Extremity Spasticity | Quadriplegic Cerebral PalsyTurkey
-
Pamukkale UniversityCompleted
-
Mersin UniversityRecruitingInternet Gaming DisorderTurkey