- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05974891
The Effect of Simulation-Based Experience on Nursing Students
The Effect of Simulation-Based Experience on the Development of Self-Awareness and Empathic Skill in Nursing Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gizem KAYA, MsC
- Phone Number: +9005396529857
- Email: gizemkaya3004@hotmail.com
Study Locations
-
-
-
Istanbul, Turkey
- Recruiting
- Istanbul University-Cerrahpasa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years old and over,
- Studying in the 4th grade,
- Having an AGNO grade point average of 1.80 and above,
- It will consist of students who agree to participate in the research.
Exclusion Criteria:
- Having a health problem that may affect the evaluation of the affective field/receiving treatment,
- Repeating courses due to failure in professional main courses,
- Refusing to participate in the research or giving up during the implementation process,
- Students who graduated from health vocational high school and received associate degree education in the field of health.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Simulated group
Pilot application will be carried out with at least 10 students. A pre-test will be applied to the experimental group. After the scales are applied, the experiment will be applied to the experimental group with the "Geriatric Medication Game" simulation. Students simulating the elderly patient role during this simulation will gain a better understanding of age-related health problems and how older adults feel when confronting them. After the application, debriefing, which is the last stage of the simulation training, will be done to evaluate the application. After the application and analysis session is completed, the post-test will be applied to the experimental group. A 3-week clinical practice will be planned for the students in the experimental groups in order to evaluate the continuation of the acquired skills and acquired awareness. In this application, students will be asked to care for the elderly patient and the pre-test will be repeated at the end of the application. |
Pilot application will be carried out with at least 10 students. A pre-test will be applied to the experimental group. After the scales are applied, the experiment will be applied to the experimental group with the "Geriatric Medication Game" simulation. Students simulating the elderly patient role during this simulation will gain a better understanding of age-related health problems and how older adults feel when confronting them. After the application, debriefing, which is the last stage of the simulation training, will be done to evaluate the application. After the application and analysis session is completed, the post-test will be applied to the experimental group. A 3-week clinical practice will be planned for the students in the experimental groups in order to evaluate the continuation of the acquired skills and acquired awareness. In this application, students will be asked to care for the elderly patient and the pre-test will be repeated at the end of the application. |
|
No Intervention: No Intervention: Control group
The control group will be pre-tested.
After the scales are applied, no intervention will be made to the control group.
A 3-week clinical practice will be planned for the students in the control group.
In this application, students in the control group will be asked to care for the elderly patient and the scales will be repeated at the end of the application.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Awareness In Nursing Practice Scale
Time Frame: It will be applied in the pre-test before recruitment. It will be applied immediately after the simulation.
|
The scale, developed by Rasheed et al. (2020) to measure the self-awareness level of nurses, was conducted by Tufan and Oskay Şahin (2021), for its validity and reliability in Turkish.
The original scale consists of 4 sub-dimensions and 18 items.
The Turkish form of the scale consists of 4 sub-dimensions and 15 items.
A 6-point Likert scale (always = 5, very often = 4, sometimes = 3, rarely = 2, very rarely =1 and never=0) is used.
There is no reverse item in the scale.
In the total score evaluation of the scale, the lowest total score is 0 and the highest total score is 75 (Tufan & Oskay Şahin, 2021).
|
It will be applied in the pre-test before recruitment. It will be applied immediately after the simulation.
|
|
Jefferson Empathy Scale for Nursing Students
Time Frame: It will be applied in the pre-test before recruitment. It will be applied immediately after the simulation.
|
The scale developed by Hojat et al. (2001), Turkish validity-reliability study was conducted by Yanık and Saygılı (2014).
The original scale consists of 20 items and 3 dimensions, but the Turkish version has 18 items.
It has been reported that the 5th and 18th items in the Turkish scale were removed by the researchers because the factor load was found to be low (Yanık & Saygılı, 2014).
The 18-item Turkish version of the scale, as in the original, consists of 3 dimensions: Obtaining an Empathic Perspective (9 items), Compassionate Care (7 items) and Viewing from the Patient's Perspective (2 items).
The scale is 7-point Likert type and the scores that can be obtained from the Turkish form vary between 18-126.
A high score indicates a high level of empathy (Yanik & Saygılı, 2014).
|
It will be applied in the pre-test before recruitment. It will be applied immediately after the simulation.
|
|
Kiersma-Chen Empathy Scale
Time Frame: It will be applied in the pre-test before recruitment. It will be applied immediately after the simulation.
|
The scale developed by Kiersma et al. (2013) was adapted into Turkish by Şahin Bayındır et al. (2022).
The original version of the scale consists of 2 subscales (Cognitive Empathy and Affective Empathy) and 15 items.
However, in the Turkish adaptation study, two items with low item-total correlation (item 4 and item 15) were removed from the scale.
The Turkish version of the scale consists of 2 sub-dimensions and 13 items.
The scale is used to evaluate empathy in nursing students and simulation training.
Responses to the scale items are scored on a 7-point Likert type (1=Strongly Disagree, 2=Disagree, 3=Somewhat Disagree, 4=Neither Agree Neither Disagree, 5=Agree Slightly, 6=Agree, 7=Strongly Agree) (Şahin-Bayindir et al., 2022).
The internal consistency coefficient of the Cognitive Empathy Subscale of the scale, which was adapted into Turkish, was 0.78; The internal consistency of the Affective Empathy Subscale was 0.74; the internal consistency coefficient of the total scale is 0.85
|
It will be applied in the pre-test before recruitment. It will be applied immediately after the simulation.
|
|
Student Satisfaction and Self-Confidence Scale in Learning
Time Frame: It will be applied immediately after the simulation
|
The scale was developed by Jeffries and Rizzolo (2006) as 13 items to measure students' simulation activity and self-confidence in learning.
Answering the scale for each item; 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, 5=Strongly Agree (Franklin et al., 2014).
The Turkish validity and reliability study of the scale was carried out by Unver et al. (2017) and the total number of items decreased to 12.
|
It will be applied immediately after the simulation
|
|
The Aging Simulation Experience Survey
Time Frame: It will be applied in the pre-test before recruitment. It will be applied immediately after the simulation.
|
The scale was developed by Chen et al. (2011) to assess students' perceptions of older adults.
In this quantitative scale, there are 13 items (7-point Likert type, 1=strongly disagree…7=strongly agree) to be filled before and after the activity regarding the experience of older adults in the health system and the structure of this system.
Except for 2 items with negative expressions, higher scores were accepted as an indicator of greater understanding and positive perceptions (Chen et al., 2015b).
In addition to 13 items, 8 items related to students' experience of navigating the health system as an older adult were reported to be filled only after the activity and student experiences related to the activity were evaluated (Chen et al., 2015a).
There is no Turkish adaptation of the scale, it is being adapted into Turkish by the researcher.
|
It will be applied in the pre-test before recruitment. It will be applied immediately after the simulation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Awareness In Nursing Practice Scale
Time Frame: 3 weeks after the simulation (after clinical practice)
|
The scale, developed by Rasheed et al. (2020) to measure the self-awareness level of nurses, was conducted by Tufan and Oskay Şahin (2021), for its validity and reliability in Turkish.
The original scale consists of 4 sub-dimensions and 18 items.
The Turkish form of the scale consists of 4 sub-dimensions and 15 items.
A 6-point Likert scale (always = 5, very often = 4, sometimes = 3, rarely = 2, very rarely =1 and never=0) is used.
There is no reverse item in the scale.
In the total score evaluation of the scale, the lowest total score is 0 and the highest total score is 75 (Tufan & Oskay Şahin, 2021).
|
3 weeks after the simulation (after clinical practice)
|
|
Jefferson Empathy Scale for Nursing Students
Time Frame: 3 weeks after the simulation (after clinical practice)
|
The scale developed by Hojat et al. (2001), Turkish validity-reliability study was conducted by Yanık and Saygılı (2014).
The original scale consists of 20 items and 3 dimensions, but the Turkish version has 18 items.
It has been reported that the 5th and 18th items in the Turkish scale were removed by the researchers because the factor load was found to be low (Yanık & Saygılı, 2014).
The 18-item Turkish version of the scale, as in the original, consists of 3 dimensions: Obtaining an Empathic Perspective (9 items), Compassionate Care (7 items) and Viewing from the Patient's Perspective (2 items).
The scale is 7-point Likert type and the scores that can be obtained from the Turkish form vary between 18-126.
A high score indicates a high level of empathy (Yanik & Saygılı, 2014).
|
3 weeks after the simulation (after clinical practice)
|
|
Kiersma-Chen Empathy Scale
Time Frame: 3 weeks after the simulation (after clinical practice)
|
The scale developed by Kiersma et al. (2013) was adapted into Turkish by Şahin Bayındır et al. (2022).
The original version of the scale consists of 2 subscales (Cognitive Empathy and Affective Empathy) and 15 items.
However, in the Turkish adaptation study, two items with low item-total correlation (item 4 and item 15) were removed from the scale.
The Turkish version of the scale consists of 2 sub-dimensions and 13 items.
The scale is used to evaluate empathy in nursing students and simulation training.
Responses to the scale items are scored on a 7-point Likert type (1=Strongly Disagree, 2=Disagree, 3=Somewhat Disagree, 4=Neither Agree Neither Disagree, 5=Agree Slightly, 6=Agree, 7=Strongly Agree) (Şahin-Bayindir et al., 2022).
The internal consistency coefficient of the Cognitive Empathy Subscale of the scale, which was adapted into Turkish, was 0.78; The internal consistency of the Affective Empathy Subscale was 0.74; the internal consistency coefficient of the total scale is 0.85
|
3 weeks after the simulation (after clinical practice)
|
|
The Aging Simulation Experience Survey
Time Frame: 3 weeks after the simulation (after clinical practice)
|
The scale was developed by Chen et al. (2011) to assess students' perceptions of older adults.
In this quantitative scale, there are 13 items (7-point Likert type, 1=strongly disagree…7=strongly agree) to be filled before and after the activity regarding the experience of older adults in the health system and the structure of this system.
Except for 2 items with negative expressions, higher scores were accepted as an indicator of greater understanding and positive perceptions (Chen et al., 2015b).
In addition to 13 items, 8 items related to students' experience of navigating the health system as an older adult were reported to be filled only after the activity and student experiences related to the activity were evaluated (Chen et al., 2015a).
There is no Turkish adaptation of the scale, it is being adapted into Turkish by the researcher.
|
3 weeks after the simulation (after clinical practice)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Funda BÜYÜKYILMAZ, PhD, Istanbul University - Cerrahpasa (IUC)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-74555795-050.01.04-634230
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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