NCT05974891

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

February 26, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

July 15, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

simulationeducationEmpathic SkillSelf-awareness

Outcome Measures

Primary Outcomes (5)

  • 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).

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

  • 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).

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

  • 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

    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

    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

    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 Outcomes (4)

  • Self-Awareness In Nursing Practice Scale

    3 weeks after the simulation (after clinical practice)

  • Jefferson Empathy Scale for Nursing Students

    3 weeks after the simulation (after clinical practice)

  • Kiersma-Chen Empathy Scale

    3 weeks after the simulation (after clinical practice)

  • The Aging Simulation Experience Survey

    3 weeks after the simulation (after clinical practice)

Study Arms (2)

Experimental: Simulated group

EXPERIMENTAL

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.

Other: Pilot application

No Intervention: Control group

NO INTERVENTION

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.

Interventions

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.

Experimental: Simulated group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

  • Funda BÜYÜKYILMAZ, PhD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 15, 2023

First Posted

August 3, 2023

Study Start

February 26, 2024

Primary Completion

April 1, 2024

Study Completion

June 30, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations