Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05331898 |
| Other study ID # |
B.30.2.ATA.0.01.00/502 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 19, 2020 |
| Est. completion date |
September 19, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study aims to examine the effect of rational drug use education given to parents on
parental attitudes. The pretest-posttest randomized controlled experimental study was carried
out in Erzurum between June 2020 and September 2021. The study's population comprised parents
with children aged 0 to 12 who were registered at an Erzurum FHC. The study sample consisted
of 100 parents who came to the FHC on the specified dates and matched research criteria.
"Parent Introductory Information Form", "Parental Attitude Scale for Rational Drug Use
(PASRDU)" and "Rational Drug Use Education" were used to collect research data.
Description:
Type of the Research The study was conducted as a randomized controlled trial with a
pretest-posttest design.
Place and Time of the Research The research was conducted between June 2020 and September
2021 in a Family Health Center (FHC) in Erzurum.
Population and Sample of the Research The study's population comprised parents with children
aged 0 to 12 who were registered at an Erzurum FHC. Using the probabilistic sampling method,
the study sample consisted of 100 parents who came to the FHC on the specified dates and
matched the research criteria. Power analysis was used to determine the sample size in the
study using the G.Power 3.1.9.2 application. In the power analysis, it was determined that
104 parents should be reached, 52 parents in the experimental group and 52 parents in the
control group, with a 95% confidence interval, 80% theoretical power, and 0.5 impact power.
At this point, 2 experimental and 2 control parents who did not want to participate in the
study were removed from the study, bringing the total number of participants to 100 (50
experimental, 50 control).
Inclusion criteria for the study;
- Being a 0-12 age group child
- Being literate
- Not having any communication problems
- Previous drug use for the child. Data Collection Tools "Parent Introductory Information
Form", "Parental Attitude Scale for Rational Drug Use" and "Rational Drug Use Education"
were used to collect research data.
Parent Introductory Information Form: In this form, which was prepared by the researcher
based on the literature, there are 13 questions in total about age, gender, place of
residence of the parents, family type, social security, socioeconomic level, educational
status, and occupation, the number of children aged 0-12, the presence of children with
chronic diseases, where they most often apply for drug treatment when their child is sick,
and the most frequently non-prescribed drugs.
Parental Attitude Scale for Rational Drug Use (PASRDU): It was developed in 2018. The scale
consists of 2 sub-dimensions and 40 items. The sub-dimensions of the scale "Correct and
Conscious Use" consist of 29 items and "Effective and Safe Use" consists of 11 items. PASRDU
is a 5-point Likert-type scale consisting of five questions with the answers "(1) strongly
disagree, (2) disagree, (3) indecisive, (4) agree, (5) strongly agree". While 12 of the 40
items in the scale were negative (16,30,31,32,33,34,35,36,37,38,39,40) statements, 28 items
consisted of positive statements. The negative items were reverse-scored. The higher the
score obtained from the scale, the higher the positive attitude of parents towards rational
drug use.
Rational Drug Use Education: An education booklet was created by the researchers based on the
literature. What is a drug? What is rational drug use? What are the benefits of rational drug
use? What are the principles of rational drug use? What is irrational drug use? What are the
main effects of irrational drug use? What are the problems of irrational drug use? Who makes
up the rational drug use team? What are the most common errors mothers make when giving their
children drugs? What should be known about rational drug use? What should we pay attention to
when giving a drug to children? These are some of the questions it contains.
Data Collection Control Group: Initially, control group data were collected. In the first
interview, pre-test data were collected by applying the "Parent Introductory Information
Form" and "Parental Attitude Scale for Rational Drug Use". It took roughly 15-20 minutes to
complete the forms. No education was provided. Covid-19 precautions were taken while
collecting data. One month after the pre-test application, the post-test was applied.
Post-test data were collected by the telemonitoring method.
Experimental Group: In the first interview, pre-test data were collected by applying the
"Parent Introductory Information Form" and "Parental Attitude Scale for Rational Drug Use. It
took roughly 15-20 minutes to complete the forms. A PowerPoint presentation developed by the
researcher was used to provide rational drug use training. The parents were given the
prepared education booklet so that they may utilize it whenever they required it. Covid-19
precautions were taken while collecting data. One month after training, posttest data were
collected. Telemonitoring method was used to collect post-test data.
Variables of the Research Dependent Variable: "Parental Attitude Scale for Rational Drug Use"
score averages of parents Independent Variable: "Rational Drug Use" education given to
parents Control Variable: Introductory characteristics of parents Evaluation of the Data
Statistical analysis of the research data was evaluated using the SPSS 22.0 (Statistical
Package for Social Science) package program. Continuous variables were given as mean±standard
deviation and categorical variables as numbers and percentages. The student's t-test was used
for two-group comparisons of normally distributed quantitative data. A Paired-Sample t-test
was used to compare the normally distributed scale scores before and after education.
Additionally, differences between categorical variables were analyzed by Chi-square analysis.
The significance level was set as p˂0.05.
Ethical Principles of the Research Ethical approval of the Ethics Committee was obtained for
the study. The research group's parents were informed about the study's purpose, their
questions were answered, and their verbal and written consents were obtained. The parents
were informed that the information they supplied would be kept private and would not be
shared with anyone else and that they had the right to withdraw from the study at any time.
Since the use of the human phenomenon requires the protection of individual rights, the
relevant ethical principles "Principle of Informed Consent", "Principle of Volunteering" and
"Principle of Protection of Confidentiality" were fulfilled in the research.
