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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Hamiyet Kızıl

    Istanbul

Other trials in Turkey (Türkiye)

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 groups in NCT06800235
Study groupRoleWhat they receive
Control Group (Standard Procedure)OtherNursing 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 GroupExperimentalNursing 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.

  1. Aspiration Skill Self-Assessment score average

    Nursing students were informed about the Aspiration Skill Self-Assessment Form

    Measured: 1 month

  2. 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.

  1. First posted29 Jan 2025
  2. Study start20 Nov 2024
  3. Primary completion20 Nov 2024
  4. Study completion20 Dec 2024

Resources

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)
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.

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.

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