Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04444258 |
| Other study ID # |
2020/263 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2020 |
| Est. completion date |
September 10, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Karabuk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, it was aimed to design virtual pregnancy for pregnancy formation, fetal and
placental development in the virtual reality environment and to evaluate the effectiveness of
the designed virtual pregnancy on midwifery education.
Our study, which will be the first in our second country in the world, aims to reduce the
application errors and determine deviations from normal by examining the formation of
pregnancy, maternal, fetal and placental changes, which form the basis of midwifery
profession, before having clinical experience. In this direction, the objectives of our study
are;
- Development of the virtual pregnancy application, which will be designed for the first
time in our country,
- Ensuring the effective use of virtual pregnancy practice in midwifery education,
- Visualizing fetal and placental development with virtual pregnancy that will form the
basis of midwifery education,
- To minimize the application errors experienced in clinical practices of midwifery
students,
- To increase educational effectiveness, clinical and academic success by visualizing the
formation of pregnancy.
- Measuring cognitive loadings of students after education
- Measuring students' sense of readiness
Description:
Today, simulation education is gradually increasing and it is used effectively in the field
of midwifery education (1). It is observed that simulation education is used effectively
during midwifery, pregnancy, delivery or postpartum period (2,9). Providing a virtual reality
perspective to midwifery simulation training will enable students to use midwifery practices
effectively before going to clinical practice (3,5). Teaching of pregnancy, which forms the
basis of midwifery education, with virtual reality application will minimize clinical
application errors and will provide early diagnosis of fetal presentation and placental
anomalies that will be able to experience pregnancy and childbirth. They will be able to
effectively see the differences that occur as pregnancy progresses and the maternal-fetal
response to these differences. It is an up-to-date and important subject that will enable
them to see the pregnancy process, maternal-fetal development, placental differences and
mother's circulatory response in three dimensions without any obstacle in midwifery education
with virtual pregnancy application (4,6,7,8,9).
Since this application is a newly developed technique, it will create a current perspective
on midwifery education and fill the gap in the virtual reality simulation in its education,
and will provide a basis for midwifery education and literature. Although there are studies
on simulation in midwifery or health in our country, there is no study that combines and
applies virtual reality and pregnancy in midwifery. In the studies related to virtual reality
and health field and midwifery profession in the world, the profession of virtual reality has
been supported in studies that have positive effects on education.
Type of the Study: The study is planned to be an experimental study designed as an
experimental and control group.
Location and Date of the Research: The study will be conducted in the Midwifery Department of
the Faculty of Health Sciences of Karabuk University and between November 2019 and October
2020.
The research consists of 2 parts. In Part I, Virtual Reality Application will be Developed.
Virtual pregnancy software will be prepared through service procurement. For this, fetal
development and fetal physiology will be written in detail by researchers week by week and
virtual pregnancy will be created.
II. The application of the research will be done in the department.
SECTION I: Development of Virtual Reality Application
In the 1st part of the research, the software of virtual pregnancy will be prepared through
service procurement. For this, algorithms will be created by researchers in detail by writing
fetal development, fetal physiology and anatomy weekly. This algorithm will be transferred to
the glasses based on images and drawings (10,11) of fetal development weekly and weekly
images of fetal development from the book of Obstetrics and Gynecology, and the images shared
on the internet for fetal development. As stated in the budget form, service will be
purchased for the development of the Virtual Pregnancy software. TUBITAK will be applied for
this service.
With the Virtual Pregnancy application,
- Learning pregnancy formation week by week,
- To follow placental development and to understand deviations from normal,
- It will provide the opportunity to learn normal fetal development and besides,
information will be remembered for a long time. In this way, its effectiveness in
virtual pregnancy midwifery education will be evaluated.
II. Department: Application of the Research
In this last part of the research, the application part of the research has been started. The
research will consist of 3 groups, 2 experimental groups and a control group. 35 students
will be admitted to each group as a result of G-power analysis calculated with 0.95 power.
The Universe of the research will consist of 464 Midwifery students studying at Karabuk
University.
The sample will consist of 105 midwifery students, including 35 control, 35 experiment I and
35 experiment II, as a result of the G-power analysis calculated by 0.95 power, among the
midwifery students who took theoretical 4 hours in their curriculum within the scope of the
week of week, including fetal development.
Experimental I Group: After the Fetal Development Assessment Information Form (FEGBF), a
computer-aided and guided virtual reality application prepared by the researchers including
the phases of the fetus week by week will be watched and then FEGBF will be applied again by
changing the locations of the questions.
Experiment II Group: Following the Fetal Development Assessment Information Form (FEGBF), the
computer-aided and unguided virtual reality application prepared by the researchers including
the fetal development week by week will be monitored, and then FEGBF will be applied again by
changing the locations of the questions.
Control Group: FEGBF will be applied after 4 hours of theory training. Virtual pregnancy
application will not be watched.
At the first stage: after 4 hours of theory training to all three groups, the information
form (FEGBF) prepared by the researchers to be used in this research will be applied as the
first test.
In the second stage: No application will be made to the control group, computer-aided and
guided virtual reality application will be applied to the experimental group, and
computer-free and non-guided virtual application will be monitored to the experiment II
group.
In the third phase: Post-tests will be applied by changing the locations of FEGBF questions.
After the 4-hour theory training for the control group, the posttest will be done after the
virtual birth application is watched on the experiment groups. Also, at this stage,
"Cognitive Load Scale" and "Feel of Inventory" will be applied to the experimental groups
after the application.
In the fourth stage: After 6 weeks, all three groups will be relocated to FEGBF, and the
effectiveness of the application of virtual birth will be examined in remembering and
recalling the information.
In order not to affect the groups determined by the computer-aided randomization program
according to the class list order as the experiment and control groups, the students will not
be informed which one is in the experiment and which is in the control group. Since virtual
pregnancy application will be applied to all experimental group students on the same day, the
possibility of students being affected by each other will be excluded.
Students who could not participate in the study and were selected as a control group in
randomization will also be provided with virtual reality glasses after the study, so that all
students will see the virtual birth application and equality will be achieved.
Randomization of the Study: The class list of the students who agree to participate in the
study will be transferred to the computer supported randomization program and the groups will
be determined. Sufficient sample size will be provided by choosing again from the students
who did not participate in the study for the last minute or who did not participate in the
study for reasons such as disease or control group, who accepted to participate in the study
and were not selected in randomization.
Teaching complex procedural information by simulation may cause cognitive load in learners
(6). The way to reduce cognitive load and increase teaching achievements is to establish a
sample based system. Thus, the use of rules and examples through modeling simplifies the
process of learning complex procedures. For this reason, the directive on the use of VR and
sample application videos will be presented to the learners as modeling.
Data Collection Tools:
Data collection form: It is planned to apply a form consisting of 15 questions, which
includes the characteristics of the participants such as age, marital status, educational
status and family type.
Fetal Development Assessment Information Form (FEGBF): For the preparation of the information
form, the latest literature information, midwifery core curriculum (EUÇEP) created by YÖK was
reviewed and an information form consisting of 42 questions related to fetal physiology
issues and phases of fetal development was prepared. The items in the information form will
be presented to the students in the form of a full sentence that can be true or false, and
students will be asked to answer these statements as "True" or "False". Total response time
is 30 minutes. Correct answers will be evaluated as 1 point, Wrong answers will be evaluated
as 0 points. Wrong expressions were also used in the information form, and these items were
coded in reverse compared to others. The lowest score to be taken from the information form
is 0 and the highest total score is 42.
Cognitive Load Scale: Kılıç et al. (2004) "Cognitive Load Scale" (BYÖ) adapted to Turkish
will be used. It has single factor and nine points (very little, very little, little, partly
little, neither more nor less, more, more, more, more, more, more or more). The Cronbach
Alpha internal consistency coefficient of the original version was found to be 0.90. Kılıç et
al. (2004) in the adaptation study, the Cronbach Alpha internal consistency coefficient was
found as .78. The lowest point of the scores obtained from the scale is 1.00, the middle
point is 5.00 and the highest point is 9.00. Participants scoring below five points were
evaluated as "cognitively overloaded", and participants scoring above 5 points were evaluated
as "cognitively overloaded" (12).
Availability Sensitivity Scale: It is a scale that was originally 7-likert type in Turkish
validity reliability in 2018, but reduced to 5-likert type in Turkish validity. Cronbach
Alpha reliability coefficient of the scale was calculated as 0.91. The scale measures the
sense of presence in virtual reality-based learning environments. The scale has 5 factors
(lower size): Participation (Factor 1), Cohesion / Surrounding (Factor 2), Sensory Commitment
(Factor 3), Interaction (Factor 4) and Interface Quality (Factor 5) and consists of 29
questions (13 ).
Ethical Aspect of the Research: The study will start after obtaining the ethics committee
permission from the non-interventional research ethics committee of Karabük University, and
the informed volunteer consent form will be obtained from each student who agrees to
participate in the study.
Data Analysis of the Research: Analysis of the data of the study will be done using IBM SPSS
for Mac book 24 version. Average values will be taken for socio-demographic characteristics.
In study models with experiment / control groups, the experimental group is tested / tested
and finally tested. The same test will be applied to the control group without experiment.
Whether the difference between the measurements of the three groups is meaningful or not will
be calculated using "z or t test for independent groups". For statistical significance, p
<0.05 level will be accepted. While evaluating the study data, frequency distributions for
categorical variables and descriptive statistics (mean, standard deviation, median, minimum,
maximum) for numerical variables will be used. Whether there is a relationship between two
categorical variables will be checked by Chi-Square analysis and whether there is a
relationship between two numerical variables will be examined by Pearson Correlation
analysis. If the number of groups is two, whether there is a difference between the variables
and the scores, it will be tested with the "significance test of the difference between the
two averages" (independent t test), and if the group number is more than two, "one way
variance analysis" (ANOVA). As a result of the analysis, first of all, the Levene test for
variance homogeneity will be checked by the "multiple comparison test" (Bonferroni or
Tamhane's T2), from which group or groups the difference originated.
