Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06081751 |
| Other study ID # |
Sbati |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 23, 2022 |
| Est. completion date |
February 22, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Necmettin Erbakan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Traditional games are games based on interpersonal communication and creativity, mostly
involving physical activity. These aspects have positive contributions to the development of
the child. Studies show that group games that include physical activity cause a decrease in
children's stress levels. Playing as a team member and working for a common goal can
contribute to the social development of the child.
Today, with the development of technology, the interest in games played with the internet has
increased, which has caused children to be drawn from the streets to their homes. Turning to
internet games also prevents children from socializing and causes them to lead a sedentary
life. Spending more time on internet games causes sleep problems, conflict with family
members, decrease in school success, increase in stress level, and delay in social skills. It
is stated that nurses have important responsibilities in preventing excessive internet use,
which affects children's physical, mental and social development. It is thought that this
study will help children spend their free time with activities that will positively affect
their development through traditional children's games, and thus contribute to the reduction
in internet usage times and stress levels.
Description:
Today, with the development of technology, the interest in games played with the internet has
increased, which has caused children to be drawn from the streets to their homes. Turning to
internet games also prevents children from socializing and causes them to lead a sedentary
life. Spending more time on internet games causes sleep problems, conflict with family
members, decrease in school success, increase in stress level, and delay in social skill. It
is stated that nurses have important responsibilities in preventing excessive internet use,
which affects children's physical, mental and social development. It is thought that this
study will help children spend their free time with activities that will positively affect
their development through traditional children's games, and thus contribute to the reduction
in internet usage times and stress levels.
MATERIALS AND METHODS Purpose of the research The research was carried out to determine the
effect of traditional children's games on internet usage time and stress level.
hypotheses H0 a = There is no difference in the duration of internet use between the
experimental and control groups.
H0 b = There is no difference between the total scores of the Perceived Stress Scale in
Children (8-11 years) between the experimental and control groups.
Type of Research The research is a pre-test, post-test, parallel group, randomized controlled
study to determine the effect of traditional children's games on internet usage time and
stress level.
Location and Characteristics of the Research The research was carried out in Seydişehir
Mahmut Esat Secondary School affiliated to Konya Provincial Directorate of National
Education. The reason for choosing this school is that it is one of the schools with a high
number of students in the district of Seydişehir and has easy transportation. There are 1079
students enrolled in Seydişehir Mahmut Esat Secondary School in the 2021-2022 academic year.
The school has a total of 18 classes and 516 students, nine of which are in the 5th and 6th
grades, and nine are in the 6th grade. Schools provide full-time education. There are no
infirmaries and nurses in schools. School gardens and gymnasiums are adequate for play.
Population and Sample of the Research The universe of the research consisted of 516 students
enrolled in the 5th and 6th grades in the related school in the 2022-2023 academic year. The
reason for the inclusion of students in this age group in the study is that they use the game
as a tool to reflect the developmental characteristics of the children. For the study group
of the experimental research, a computer-assisted simple random numbers table was prepared by
an independent statistics expert among 516 students. 108 students were selected by simple
random sampling. 30 students included in the study were randomly assigned to the experimental
and 30 control groups.
The work will be carried out in two stages. In the first stage, Parental Consent Form",
"Descriptive Characteristics Form" will be sent to the families of the students at the
school. According to the answers from the parents, the children's internet usage time and
frequency will be determined, and students with more internet usage time (more than 2 hours a
day) and frequency (who use the internet every day) will be included in the sample.
The sample size of the study was calculated based on the results of different studies:
In a study examining the effects of traditional children's games on internet addiction,
social skills and stress levels, the stress post-test mean scores of the group that played
and did not play traditional games were 75±43.15 in the experimental group and 253.31±29.19
in the control group. According to these values, it was calculated that the sample size
should be at least 60 (30/30) with an effect size of 0.77, a power of 0.80 and a margin of
error of 0.05, according to the calculation made in the G*Power 3.1.4 package program.
Randomization After obtaining their consent and pre-testing, the 60 students who make up the
study group of the experimental research will create a random number sequence by an
independent statistician and will be assigned to the experimental (30) and control (30)
groups with a simple randomization method (www.randomizer.org). A separate randomization
table for girls and boys was created from the created class list (Table 4).
CONSORT CHART This study is a randomized controlled pretest-posttest study. It has been
planned in accordance with the CONSORT criteria.
Inclusion Criteria for Participants in the Study
- Approval by the student's family to participate in the study
- Internet usage time is more than 2 hours a day and its frequency is every day
- Willingness to participate in the research Criteria for Exclusion of Participants in the
Study
- Having a physical, orthopedic or mental illness or disability that may interfere with
playing
- Regularly participating in sporting events
- Occurrence of unwanted injury during traditional children's games
- Not being able to attend the traditional children's play program for at least two weeks.
Data Collection Technique and Tools In the collection of research data; The descriptive
features form developed by the researchers and the perceived stress scale in children (8-11
years) will be used.
Descriptive Characteristics Form It includes socio-demographic information about the child
and parent, and information about the duration of internet use.
Perceived Stress Scale in Children (8-11 years) It was developed by Snoeren-Hoefnagels (2014)
and adapted into Turkish by Oral and Ersan in 2017. When the child evaluates the past week,
he is asked to give answers about how appropriate each item is for him. The scale consists of
9 items. It is a 4-point Likert scale. It consists of a single sub-dimension. Responses to
the items were graded as 'never', 'sometimes', 'often' and 'always'. Never gets one point and
always gets 4 points. A minimum score of 9 and a maximum score of 36 are obtained in the
scale without reversed items. High scores on the scale questions mean that the individual's
stress level is high.
Data Collection Data Collection Pre-tests will be applied after obtaining written consent
from the experimental and control groups in the 2022-2023 academic year. After the
application program is completed, the final tests will be applied to the experimental and
control groups.
Application of Research Experimental group The study will be carried out in the 2021-2022
academic year after the necessary permissions are obtained. Before the application,
information will be given by meeting with the school administration and teachers. In a closed
envelope to the parents of the students in the intervention and control groups;
- Parental Consent Form
- A Descriptive Characteristics Form will be sent and parents who agree to participate in
the study will be asked to fill in the other forms in the envelope. The envelopes sent
will be collected by the teachers after 1 week.
Students who were allowed to participate in the study with a consent form by their parents
and who have more internet usage time (more than 2 hours a day) and frequency (who use the
internet every day) according to the data specified in the "Descriptive Characteristics Form"
will be included in the study. The "Perceived Stress Scale for Children (8-11 Years)" will be
administered to the children included in the sample.
Children in the intervention group will be played for 60 minutes, 3 days a week for 8 weeks,
according to the rules set in the "Traditional Children's Games Festival Games Guide Booklet"
prepared by the Ministry of National Education and the Ministry of Youth and Sports.
After the program is completed, the "Perceived Stress Scale for Children (8-11 Years)" will
be re-applied to the students, the parents will be sent the Descriptive Characteristics Form
again in a closed envelope and asked to fill in, and it will be collected by the teachers 1
week later.
No attempt will be made on the control group. Pre-test-post-tests will be applied in parallel
with the intervention group at the same time.
blinding Subjects will not be blinded due to the active role of the intervention group in the
study. Blinding will be done in statistics and reporting in the research. The input of the
research data (pre-tests and post-tests and transferring the data to the computer) will be
entered with "A" and "B" codes without specifying the experimental or control group. The
analysis of the data will be done by an independent statistician. After the statistical
analysis is made and the research report is written, the coding for the experimental and
control groups will be explained to the expert by the coder. Researchers will be blinded to
statistical analysis until the study is complete.
Variables of the Study Dependent variables: Internet use and stress level Independent
variables: Playing traditional children's games Ethical Dimension of Research
- Permission will be obtained from the Ethics Committee of the Faculty of Health Sciences
of Necmettin Erbakan University.
- Permission was obtained from the Ministry of National Education.
- Written permission was obtained from the authors for the use of scales.
- Written consent will be obtained from the children's parents.
- Verbal consent will be obtained from children. Limitations of the Research The findings
of the study can only be generalized to the universe in which the study was conducted.
In the implementation process of the research, there may be difficulties in ensuring the
voluntary basis, since the application will be made to the participants during
extracurricular times and after school.
Statistical Evaluation of Data The data obtained from the research will be evaluated with the
SPSS 20.0 (Statistical Package for Social Sciences) package program. Number, percentage, mean
and standard deviation will be used as descriptive statistics in the evaluation of the data.
Chi-square test or McNemar test will be used to compare categorical data. In the analysis of
the data, Mann Whitney U test will be used in independent groups and Wilcoxon Signed Rank
Test will be used in dependent groups. Significance level will be accepted as p<0.05.
