Nursing EducationNCT05283772
Developing and Examining the Effectiveness of an Eye Tracker for Simulation Training
A study testing Development of eye tracker for simulation training in nursing in people with Nursing Education and Eye Tracker, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Today, rapid developments in technology and science; affected the economic, cultural, political and social fields. The use of technology in these areas has become a necessity rather than a privilege. Education is one of the areas where technology is used the most and most intensely affected. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Education, Eye Tracker, Simulation Training
- What is being tested?
- Development of eye tracker for simulation training in nursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 20 Apr 2022
- 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
- To be a 3rd year student at Pamukkale University nursing department in order to be included in the pilot study.
- To be a 4th year student of Pamukkale University nursing department in order to be included in the main application.
- Not working as a nurse in any institution (high school/associate graduate nurse).
- Volunteer to participate in the study.
Who cannot join
- Not being a student of Pamukkale University nursing department (3rd year student for pilot study-4th year student for main application) on the specified dates.
- Working as a nurse in any institution (high school / associate degree nurse).
- Not volunteering to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydin Adnan Menderes Üniversitesi
Aydin, 09100
About this study
Official title: Developing and Examining the Effectiveness of an Eye Tracker for Simulation Training in Nursing: A Double-blind Randomized Controlled Study
Today, rapid developments in technology and science; affected the economic, cultural, political and social fields. The use of technology in these areas has become a necessity rather than a privilege. Education is one of the areas where technology is used the most and most intensely affected. Different education and training technologies can be used at every stage of the education and training process. With the effective and correct use of technology, it is possible to provide efficient and effective service in the fields of education and health care. This situation is gaining more and more importance for our country in the fields of nursing practice and education. Nursing organizations accept technology as the basic building block of nursing education and practice. Simulation is defined as "a technique of developing real patient experiences and the most important aspects of the real world from experience using practice guides in a completely interactive way". According to the World Health Organization, the use of simulation methods for teaching and learning is one of the gold standards in nursing education. In the world, eye tracking systems are used to determine the focal point. Eye tracking technology aims to record the movement of the eyeball to determine where the person is focusing while performing certain tasks. These systems have also contributed to the study of cognitive and neurological development. It has started to be used together with simulation training in health education. By determining where the student focuses during clinical practice simulation training using an eye tracker, it is possible to reschedule the practice training or to provide feedback on the student's misapplications during the application. The purpose of this research; The aim of this study is to develop an eye tracker for simulation training in nursing and to examine the effectiveness of an eye tracker in a simulation scenario.
Read the detailed description
It is a double-blind randomized controlled experimental study in which two groups (experiment-control) will be compared and a post-test control group design will be used. The study consists of 2 stages. Stage 1: a) Developing the eye tracker, b) Preparing the simulation scenario and c) Conducting the pilot study. Stage 2: a) To examine the effectiveness of the developed eye tracker. To be included in the pilot study, it is necessary to be a 3rd year student of the nursing department, and to be a 4th year student of the nursing department to be included in the main application. 10 students will be included for the pilot study. The sample size was calculated in the G power statistics program by utilizing the data of a study in which on nursing students using a simulation intervention was previously performed (α =0.05, d=1.18). Accordingly, it was found that 13 people should be taken for each group to sampling for 80% power. Considering that there might be losses, the number of samples was increased by 10% and it was planned to include a total of 30 people in the study. Intention-to-treat analysis will be performed to manage bias and losses. After the eye tracker pilot application, eye tracker analysis data and video feedback data will be shared with students. Then, the personal information form to be used in the study, the simulation design scale, the student satisfaction and self-confidence scale in learning will be filled and analyzed. At the end of simulation, feedback will be received from the students participating in the pilot application Necessary changes will be made in the application simulation and eye tracker application in line with the feedback. Then the main application will be started. In the main application, eye tracker data and video feedback data will be shared with the experimental group students. Only video feedback data will be shared with the control group. In the main application, the forms and scales used in the pilot study will be used.
- Conditions
- Nursing Education, Eye Tracker, Simulation Training
- Being tested
- Development of eye tracker for simulation training in nursing
- Keywords
- Nursing, Education, Eye tracker, Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Development of eye tracker for simulation training in nursingBehavioural
Purpose: To develop a cost-effective and effective eye tracker for simulation training in nursing in Turkey.
The wearable eye tracker consists of a front camera that will detect the pupil and determine the gaze region of the eye, and glasses or an alternative headband to which these cameras will be connected. A portable mini-computer will be used to process the obtained images. While recording and monitoring the eye movement with the pupil detection camera, real-world images in the user's field of view will be recorded by the front camera and the focal points will be determined. By establishing a linear connection between these found points, temperature (heat) maps will be created at the points where the eye looks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Behavioral: Development of eye tracker for simulation training in nursing |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Students' Satisfaction and Self-confidence Scale
This instrument is a 13-item scale used to measure student satisfaction with the simulation activity (5 items) and self-confidence in learning (8 items). Cronbach's alpha for satisfaction was 0.94; for self-confidence, it was 0.87. Responses are rated on a 5-point Likert scale with values ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher satisfaction and greater levels of selfconfidence.
Measured: up to 2 weeks
Simulation Design Scale
The SDS is a 20-item tool developed to measure constructs from the Jeffries and Rizzolo (2006) simulation model. The design features rated by the students include objectives and information (five items), student support (four items), problem-solving (five items), guided reflection or feedback (four items), and fidelity (two items). Cronbach's alpha for the instrument was 0.92. Responses are rated on a 5-point Likert scale with values ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate increased recognition of design features in simulation.
Measured: up to 2 weeks
Personal Information Form
The personal information form consists of a total of 9 questions about students' demographic information, reasons for choosing the nursing profession, and simulation experiences.
Measured: up to 2 weeks
Secondary outcomes (1)
Wound dressing checklist
It is a checklist developed by taking expert opinion on wound dressing. Before the study, students will be trained on wound dressing. This checklist will be used to assess students' proficiency in wound dressing application following the training provided.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start15 Mar 2022
- Primary completion15 Mar 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing EducationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Halil Öztürk, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283772
- Sponsor's protocol ID
- E-76261397-050.99-37648
- Status last verified
- Aug 2022
- First submitted
- 17 Feb 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Examining the Effectiveness of an Eye Tracker for Simulation Training in Nursing: A Double-blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05283772
- Acronym / sponsor ID
- E-76261397-050.99-37648
- Conditions
- Nursing Education, Eye Tracker, Simulation Training
- Keywords
- Nursing, Education, Eye tracker, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 17 Mar 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.
Today, rapid developments in technology and science; affected the economic, cultural, political and social fields. The use of technology in these areas has become a necessity rather than a privilege. Education is one of the areas where technology is used the most and most intensely affected. Different education and training technologies can be used at every stage of the education and training process. With the effective and correct use of technology, it is possible to provide efficient and effective service in the fields of education and health care. This situation is gaining more and more importance for our country in the fields of nursing practice and education. Nursing organizations accept technology as the basic building block of nursing education and practice. Simulation is defined as "a technique of developing real patient experiences and the most important aspects of the real world from experience using practice guides in a completely interactive way". According to the World Health Organization, the use of simulation methods for teaching and learning is one of the gold standards in nursing education. In the world, eye tracking systems are used to determine the focal point. Eye tracking technology aims to record the movement of the eyeball to determine where the person is focusing while performing certain tasks. These systems have also contributed to the study of cognitive and neurological development. It has started to be used together with simulation training in health education. By determining where the student focuses during clinical practice simulation training using an eye tracker, it is possible to reschedule the practice training or to provide feedback on the student's misapplications during the application. The purpose of this research; The aim of this study is to develop an eye tracker for simulation training in nursing and to examine the effectiveness of an eye tracker in a simulation scenario.
Detailed description
It is a double-blind randomized controlled experimental study in which two groups (experiment-control) will be compared and a post-test control group design will be used. The study consists of 2 stages. Stage 1: a) Developing the eye tracker, b) Preparing the simulation scenario and c) Conducting the pilot study. Stage 2: a) To examine the effectiveness of the developed eye tracker. To be included in the pilot study, it is necessary to be a 3rd year student of the nursing department, and to be a 4th year student of the nursing department to be included in the main application. 10 students will be included for the pilot study. The sample size was calculated in the G power statistics program by utilizing the data of a study in which on nursing students using a simulation intervention was previously performed (α =0.05, d=1.18). Accordingly, it was found that 13 people should be taken for each group to sampling for 80% power. Considering that there might be losses, the number of samples was increased by 10% and it was planned to include a total of 30 people in the study. Intention-to-treat analysis will be performed to manage bias and losses. After the eye tracker pilot application, eye tracker analysis data and video feedback data will be shared with students. Then, the personal information form to be used in the study, the simulation design scale, the student satisfaction and self-confidence scale in learning will be filled and analyzed. At the end of simulation, feedback will be received from the students participating in the pilot application Necessary changes will be made in the application simulation and eye tracker application in line with the feedback. Then the main application will be started. In the main application, eye tracker data and video feedback data will be shared with the experimental group students. Only video feedback data will be shared with the control group. In the main application, the forms and scales used in the pilot study will be used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Development of eye tracker for simulation training in nursing |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be a 3rd year student at Pamukkale University nursing department in order to be included in the pilot study.
- To be a 4th year student of Pamukkale University nursing department in order to be included in the main application.
- Not working as a nurse in any institution (high school/associate graduate nurse).
- Volunteer to participate in the study.
Key exclusion criteria (3 listed)
- Not being a student of Pamukkale University nursing department (3rd year student for pilot study-4th year student for main application) on the specified dates.
- Working as a nurse in any institution (high school / associate degree nurse).
- Not volunteering to participate in the study.
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 |
|---|---|---|
| Development of eye tracker for simulation training in nursingPurpose: To develop a cost-effective and effective eye tracker for simulation training in nursing in Turkey. The wearable eye tracker consists of a front camera that will detect the pupil and determine the gaze region of the eye, and glasses or an alternative headband to which these cameras will be connected. A portable mini-computer will be used to process the obtained images. While recording and monitoring the eye movement with the pupil detection camera, real-world images in the user's field of view will be recorded by the front camera and the focal points will be determined. By establishing a linear connection between these found points, temperature (heat) maps will be created at the points where the eye looks. | Behavioural | Experimental |
Primary outcome
Students' Satisfaction and Self-confidence Scale
Time frame: up to 2 weeks
This instrument is a 13-item scale used to measure student satisfaction with the simulation activity (5 items) and self-confidence in learning (8 items). Cronbach's alpha for satisfaction was 0.94; for self-confidence, it was 0.87. Responses are rated on a 5-point Likert scale with values ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher satisfaction and greater levels of selfconfidence.
Simulation Design Scale
Time frame: up to 2 weeks
The SDS is a 20-item tool developed to measure constructs from the Jeffries and Rizzolo (2006) simulation model. The design features rated by the students include objectives and information (five items), student support (four items), problem-solving (five items), guided reflection or feedback (four items), and fidelity (two items). Cronbach's alpha for the instrument was 0.92. Responses are rated on a 5-point Likert scale with values ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate increased recognition of design features in simulation.
Personal Information Form
Time frame: up to 2 weeks
The personal information form consists of a total of 9 questions about students' demographic information, reasons for choosing the nursing profession, and simulation experiences.
1 secondary outcome
Wound dressing checklist
Time frame: up to 2 weeks
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 4 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Development of eye tracker for simulation training in nursing in people with Nursing Education and Eye Tracker, run by Aydin Adnan Menderes 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 4 inclusion and 3 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 4 Aug 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 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?
Students' Satisfaction and Self-confidence Scale (time frame: up to 2 weeks). 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?
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 4 Aug 2022.