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EmpathyNCT05974891

The Effect of Simulation-Based Experience on Nursing Students

A study testing Pilot application in people with Empathy and Student, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This research was planned as a randomized controlled experimental study to determine the effect of simulation training on the acquisition of self-awareness and empathy skills in nursing students. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Empathy, Student, Self Awareness
What is being tested?
Pilot application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
26 Feb 2024to 30 Jun 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul University-Cerrahpaşa

    Istanbul

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Simulation-Based Experience on the Development of Self-Awareness and Empathic Skill in Nursing Students

This research was planned as a randomized controlled experimental study to determine the effect of simulation training on the acquisition of self-awareness and empathy skills in nursing students.

Read the detailed description

Simulation is defined as one of the methods that enables students to increase their knowledge and performance in an unreal, safe and risk-free environment and gain experience. Recent research involving the use of simulation in nursing education has mostly focused on the development of cognitive learning and psychomotor skills. However; A limited number of simulation studies have been found that include empirical evaluation of affective learning domains such as affective awareness, self-awareness and empathy. As well as the cognitive and psychomotor domains of nurse educators; It is very important for them to develop strategies to strengthen the affective field. It is predicted that the proportion of the elderly population in our country will increase in the coming years. With the increase in the elderly population, it is likely that there will be changes in the patient profile that nurses who are responsible for 24/7 individual care will encounter. Professional development is required to meet the needs of elderly patients. It is of great importance for nursing students who are still in the education stage to raise this awareness, to increase their self-awareness, to empathize with elderly individuals and to gain these characteristics. In this context, it is aimed to present results on the effects of the simulation scenario designed on the care of elderly individuals and the application of "Geriatric Medication Game" on the self-awareness levels and empathy skills of nursing students. Geriatric Medication Game is an aging simulation game that combines the experiences and challenges of older adults in healthcare and a structured role-playing where students assume the identity of healthcare-seeking seniors. It is designed to influence student attitudes and understanding of older adults and the healthcare system.

Being tested
Pilot application
Keywords
simulation, education, Empathic Skill, Self-awareness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pilot applicationOther

    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.

Study groups in NCT05974891
Study groupRoleWhat they receive
Experimental: Simulated groupExperimentalPilot 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.
Receives: Other: Pilot application
No Intervention: Control groupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-Awareness In Nursing Practice Scale

    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).

    Measured: It will be applied in the pre-test before recruitment. It will be applied immediately after the simulation.

  2. Jefferson Empathy Scale for Nursing Students

    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).

    Measured: It will be applied in the pre-test before recruitment. It will be applied immediately after the simulation.

  3. Kiersma-Chen Empathy Scale

    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

    Measured: It will be applied in the pre-test before recruitment. It will be applied immediately after the simulation.

  4. Student Satisfaction and Self-Confidence Scale in Learning

    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.

    Measured: It will be applied immediately after the simulation

  5. The Aging Simulation Experience Survey

    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.

    Measured: It will be applied in the pre-test before recruitment. It will be applied immediately after the simulation.

Secondary outcomes (4)
  1. Self-Awareness In Nursing Practice Scale

    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).

    Measured: 3 weeks after the simulation (after clinical practice)

  2. Jefferson Empathy Scale for Nursing Students

    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).

    Measured: 3 weeks after the simulation (after clinical practice)

  3. Kiersma-Chen Empathy Scale

    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

    Measured: 3 weeks after the simulation (after clinical practice)

  4. The Aging Simulation Experience Survey

    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.

    Measured: 3 weeks after the simulation (after clinical practice)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2023
  2. Study start26 Feb 2024
  3. Primary completionApr 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05974891
Sponsor's protocol ID
E-74555795-050.01.04-634230
Status last verified
Mar 2024
First submitted
15 Jul 2023
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Pilot application in people with Empathy and Student, run by Istanbul University - Cerrahpasa 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 4 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gizem KAYA, MsC (+9005396529857, gizemkaya3004@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 5 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 6 Mar 2024.

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