Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05672446 |
| Other study ID # |
1234567 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 5, 2019 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
January 2023 |
| Source |
Yuksek Ihtisas University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Performing simulation applications using standardized patients provides realistic
educational results that support critical thinking and learning, conducted using complex,
effective communication scenarios.
Objective: This study was planned to evaluate the effect of the use of standardized pediatric
patient practice in pediatric nursing education on the ability of nursing students to prepare
the child for the procedure.
Method: The research was conducted using a convergent parallel design, which is a mixed
method design. Ethics committee approval was obtained with the decision numbered 19/376
regarding the ethical suitability of the research. The sample of the study consists of 106
students. The students included in the study were given an introductory information form and
the state trait anxiety scale and self-efficacy efficacy scale as pre-tests, and then the
theoretical course "Preparing the child for the process according to age periods and
communicating with the child patient" was explained. The students were divided into
intervention and control groups by randomization. The students in the intervention group
participated in the simulation application using standardized pediatric patients. Qualitative
data were collected during the debriefing phase of the simulation and student satisfaction
and self-confidence in learning scale was applied to the students in the intervention group.
Before clinical practice, state trait anxiety scale, self-efficacy scale and perceived
learning scale were applied as posttests. During the clinical practice, all students were
evaluated in terms of their ability to prepare a real school-age child patient for the
procedure.
Description:
Background The use of high-fidelity simulation in healthcare education has emerged as a
solution to address clinical experiences where patient, educational, or clinical setting
limitations exist. Simulation, used to provide competence and competence in learning, is a
technique or tool that attempts are made to create features of the real world. In the
simulation performed using standardized patients; The patient or case study is portrayed by
playing the role/scenario prepared with structured steps. Use of standardized/simulated
patient in teaching; It contributes to the development of students' communication skills,
history taking and physical examination skills. Training using standardized patients cannot
be substituted for encountering real patients, but it is accepted as a practice that should
be increased in a standard and integrative way. Simulation-based education is ideal for
nursing education because it is an interactive method that can be used to help teach
cognitive, psychomotor, or affective skills to individuals or groups of any skill or
proficiency level. Simulation is a technique that can be used as a training method and/or
research method. Simulation gives the opportunity to apply techniques that cannot be applied
or tested, and provides realism and standardization. It is stated that it is beneficial to
use in high-risk applications such as pediatric applications and where the probability of
encountering students is low. For the child, the concept of illness and hospitalization
include experiences that cause fear and discomfort. The hospital environment, healthcare
professionals, materials and procedures create a sense of uncertainty for all children in the
hospital. All procedures applied in the hospital affect the child physically, emotionally,
behaviorally and cognitively. As a result, many behaviors such as fear, anxiety, anger,
aggressive behaviors, impaired concentration, and rejection of further medical applications
develop in the child. If children are not prepared before the procedure, they may become
withdrawn, never speak or become aggressive due to the fear and anxiety they experience. This
situation increases the psychological and physical pain and pain sensation of the child and
complicates the work of the healthcare team. Preparation before the procedure, support during
the procedure and follow-up after the procedure can help the child cope with invasive
interventions. Nurses trying to provide sensitive care to the child should assume that every
procedure applied to the child may be traumatic for the child.
The school-age child knows about infections and how they spread. The child in this period has
a realistic perception about the disease, the cause of the diseases and their effects on the
organs. The concept of the child's body parts and functions begins to develop. It is
important to learn the child's knowledge about hospitalization and medical procedures and
correct misunderstandings through play. Before the procedure, it is necessary to introduce
himself to the child and allow the child to introduce himself. Parents should be encouraged
to be with the child. All procedures and their reasons should be explained to the child
without using medical terminology. The materials to be used during the procedure should be
introduced to the child, and if possible, the process should be shown to the child on a toy
or anatomical drawing. Giving the child the opportunity to ask questions about the procedure
and answering their questions will reduce their anxiety. He should be allowed to choose as
much as possible and his participation in the process should be encouraged. Before starting
the procedure, the child's consent should be obtained and the child's privacy should be
considered during the procedures. It is important to be rewarded or appreciated for the
compliant behaviors displayed during the procedure.
Child health and diseases nursing is one of the fields where the use of simulation is most
necessary, since pediatric patients are more likely to be harmed by medical errors. The use
of children as standardized patients in medical education; It is not very common because the
physical and mental development of children is incomplete and it is difficult to train
children as standardized patients. However, despite the difficulties, it is very necessary to
use children as standardized patients, to protect real patients from inappropriate
experiences and to ensure patient safety. Clinical practice of child health and diseases
nursing often causes feelings of fear and anxiety, and this reduces the performance of
students. Alleviating these concerns can contribute to improving student performance and
quality of care in the pediatric clinical setting.
Studies using children as standard patients are very limited. This study was planned to
evaluate the effect of using children as standard patients on the child's ability to prepare
for procedures in pediatric nursing education.
Method
Design This research was planned to evaluate the effect of the use of standardized pediatric
patient practice in child health and diseases nursing education on the ability of nursing
students to prepare the child for the procedure. The convergent parallel design, which is one
of the mixed method designs in which quantitative and qualitative research methods are used
together, was used in the research. The purpose of the convergent parallel design is to
collect different but complementary data on the same topic in order to best understand the
research problem.
Sample and arrangements The sample of the study consists of 106 students studying in the
third year of a nursing faculty and taking the child health and diseases nursing course. The
inclusion criteria of the study are as follows; Being a third year student at the faculty of
nursing, taking the child health and diseases nursing course for the first time, being able
to speak and understand Turkish, and giving consent to participate in the research. The
exclusion criteria of the study are as follows; Being a foreign student, having taken the
Child Health and Diseases Nursing course before, not accepting to participate in the
research.
Ethical considerations Ethics committee approval was obtained with the decision numbered
19/376 regarding the ethical suitability of the study. The purpose of the study and the
process were explained to the participants, confidentiality was assured, and they were given
the freedom to withdraw from the study at any time. After the researchers explained the
informed consent form, written consent was obtained from the participants. Numbers were used
instead of real names to identify the participants, and the letter M was added to these
numbers in the intervention group and the letter K in the control group.
Measuring tools
- Introductory features form The introductory characteristics form contains the
sociodemographic data of the students and was prepared by the responsible researchers.
- Perceived learning scale The perceived learning scale was developed by Rovai et al.
(2009). The Turkish validity and reliability of the scale was performed by Albayrak et
al. in 2014. The scale consists of 9 items and has three factors. The level of
participation of each item in the scale; Definitely false (1) and absolutely true (7). A
score between 9 and 63 is obtained from the entire scale. The Cronbach's alpha value of
the scale was found to be 0.83.
- Self-efficacy efficacy scale It was developed by Sherer et al. in 1982 to measure the
individual's general self-efficacy-efficacy perception. The Turkish validity and
reliability of the self-efficacy efficacy scale was performed by Gözüm et al. in 1999.
The Cronbach's alpha value of the scale was calculated as 0.81. The scale is a 5-point
Likert type scale consisting of 23 items. For each item, one of the options 1-"Does not
describe me at all", 2-"Describes me a little", 3-"I am undecided", 4-"Describes me
well", 5-"Describes me very well' is expected to be ticked. Thus, each individual can
get a total score between the lowest 23 and the highest 115. A high total score from the
scale indicates a high perception of general self-efficacy, and a low total score
indicates a low perception of self-efficacy.
- Student satisfaction and self-confidence in learning scale The scale, which is widely
used to measure students' attitudes and beliefs about simulation, was published by the
National League for Nurses=NLN. The Turkish validity and reliability of the scale were
performed by Karaçay et al. in 2017. It consists of two sub-dimensions, "satisfaction in
learning" and "self-confidence", and a total of 13 items. The student satisfaction
sub-dimension score is obtained from the sum of the scores of the 1st, 2nd, 3rd, 4th and
5th items. The self-confidence in learning sub-dimension score is obtained from the sum
of the scores of the 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th items. The highest
total score that can be obtained from the scale is 65, and the lowest is 13. The high
score that can be obtained from the total of the scale indicates high satisfaction and
self-confidence. The Cronbach's alpha value of the scale was found to be 0.88.
- State trait anxiety scale The state trait anxiety scale was developed by Spielberger et
al. It was translated into Turkish by Öner and Le Compte (1985) and its validity and
reliability studies were carried out. The Cronbach Alpha internal consistency
coefficient for the Trait Anxiety scale ranged from 0.83 to 0.87; It was found to be
between 0.94 and 0.96 for the State Anxiety Inventory. There are 40 expressions in the
scale that individuals can use to express their feelings. The first twenty of them
measure the level of anxiety related to the situation and are scored by putting four
options for each statement. These are: "Not at all" (1), "Somewhat" (2), "Many" (3),
"Totally" (4).
- Skill checklist for preparing the school-age child for processing The skill checklist
for preparing the school-age child for processing was created by the responsible
researchers by reviewing the literature. For the content validity of the skill
checklist, expert opinion was obtained from the faculty members of Health Sciences
University, Gülhane Nursing Faculty, Department of Child Health and Diseases Nursing.
The skill checklist for preparing the school-age child for processing consists of 9 items.
While evaluating the students, each applied item was marked and it was accepted that the
student got a "1" point from that item. Accordingly, a student can get a minimum of "0" and a
maximum of "9" points from the skill checklist. The Cronbach alpha value of the skill
checklist for preparing the school-age child for processing was calculated as 0.83.
Developing Scenarios Two scenarios were used in the simulation application. The scenarios
were prepared by the responsible researchers who were trained in simulation training. While
preparing the content of the scenarios, it was necessary to choose a skill for preparing the
pediatric patient for the procedure. Taking the opinions of the faculty members of the
Department of Child Health and Diseases Nursing at the University of Health Sciences, Gülhane
Nursing Faculty, it was decided to choose the skill of preparing the child for bloodletting,
which is one of the skills that students have the most difficulty during clinical practice.
While developing the scenarios, simulation practice standards of the International
Association for Clinical Simulation and Learning Nursing (INACSL) were taken into account.
Standardized Patient Education Two school-age children aged 7-12 years were used as
standardized pediatric patients. Due to the absence of children enrolled in standardized
patient programs in our country, standardized pediatric patients were selected voluntarily
among the school-age children of the faculty members of the Faculty of Health Sciences
Gülhane Nursing Faculty. Standardized pediatric patients and their parents were informed
about the study before participating in the study and their written consent was obtained.
Their parents were present during the education of the children and the execution of the
simulation.
When a literature review was made, it was determined that in standardized patient practice, a
person should undergo 4-8 hours of training after accepting to be a "standardized patient". A
total of 8 hours of standardized patient education was conducted with standard pediatric
patients, lasting 2 hours in 4 separate sessions.
Intervention The quantitative part of the study was conducted in a randomized controlled
manner. Students were randomly divided into two groups. Students in the intervention group
were included in a simulation using standardized pediatric patients. In the simulation
application, 6 groups, 5 of which were 8 students and 1 of which were 9 students,
participated in the application. Two standardized pediatric patients played the prepared
scenarios by repeating them 3 times. A time of 10 minutes is planned for each simulation
application. One student in the group communicated with the standardized pediatric patient,
and the other students took part as observers. The simulation application was recorded with
the video recording method and the students were allowed to watch themselves in the analysis
session held after the simulation. In the last step of the study, all students went into
clinical practice and during the clinical practice, each student was evaluated in terms of
their ability to prepare the child for the procedure.
Data collection The two-hour course "Preparing the child for the procedure according to age
periods and communication with the child patient" was given to the students who formed the
universe of the research. State trait anxiety scale and self-efficacy efficacy scale were
applied as pre-tests to all students who accepted to participate in the study. In the
debriefing session, each of these questions was discussed with the students one by one. After
the debriefing session was completed, a form containing the questions asked to them in the
decoding session was given to the students and they were asked to write their answers. The
written answers of the students constitute the data of the qualitative part of this research.
After the analysis session of the simulation, the students in the intervention group were
applied the student satisfaction and self-confidence scale used in education with simulation.
After the completion of the simulation application, state trait anxiety scale, self-efficacy
efficacy scale, and perceived learning scale were administered to all students in the
intervention and control groups as post-tests.
Analysis of data In the qualitative part of this mixed method research, the written answers
given by the students to the questions asked to them during the analysis phase were analyzed
with the content analysis method, one of the qualitative data analysis methods. In this
study, deductive content analysis method was used. Qualitative data were read repeatedly by
the responsible researchers and the data in the text were coded under the categories of
"doing, watching, feeling, thinking". The editing phase was completed by analyzing the data
and placing them in the relevant categories. The reporting stage, which is the last step of
the content analysis method, was completed with the presentation of the content analysis
steps and findings.
IBM SPSS Statistics 23 package program was used for statistical calculations and analysis of
the quantitative data of the research. Normality assumptions of numerical variables were
examined with Kolmogorov Smirnov normality test. Relationships between two independent
categorical variables were interpreted with Chi-square analysis. Differences between two
independent groups (eg, control and intervention groups) were analyzed using the Independent
Sample T Test for normally distributed variables and the Mann Whitney U test for non-normally
distributed variables. The differences between two dependent numerical variables (pretest and
posttest) were examined with the Dependent Sample T test. Statistical significance in the
analyzes was interpreted at the p<0.05 level.
Theoretical framework The theoretical framework of this research is David A. Kolb's
experiential learning theory. Kolb; He designed learning in the form of a circle in his
experiential learning theory. There are four basic learning stages in this learning circle.
These stages are; These are the "concrete experience" and "abstract conceptualization"
stages, which show the conceptualization of experiences, and the "reflective observation" and
"active experience" stages, which show the transformation of experiences. Written answers to
the questions asked to the students during the analysis phase of the simulation were coded
for the concepts of "feeling", "watching", "thinking" and "doing". These concepts form the
categories of this qualitative research. Qualitative data were read repeatedly by the
responsible researchers and the data in the text were coded under the categories of "doing,
watching, feeling, thinking".
