Pediatric DisorderNCT05331898
Rational Drug Use Education Parental Attitudes
A study testing Education in people with Pediatric Disorder, run by Ataturk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Pediatric Disorder
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2020to 19 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being a 0-12 age group child
- Being literate
- Not having any communication problems
- Previous drug use for the child.
Who cannot join
- 0-12 age group without children
- Being illiterate
- Having communication problems
- The child does not use drugs.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Nursing of Faculty
Erzurum, Center, 25240
About this study
Official title: The Effect Of Rational Drug Use Education Given To Parents On Parental Attitudes
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.
Read the detailed 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.
- Conditions
- Pediatric Disorder
- Being tested
- Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
the education given increased the rational drug use of the parents.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Experimental | increase the rational drug use of the parents. Receives: Behavioral: Education |
| control | No intervention | PARENTS CANNOT USE RATIONAL MEDICATION ON THEIR CHILDREN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Attitude Scale for Rational Drug Use
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.
Measured: 15 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start19 Jun 2020
- Primary completion27 Jan 2021
- Study completion19 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DisorderStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZU SARIALİOĞLU, Ataturk University
- Investigators
- ARZU SARIALİOĞLU, PHD, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331898
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/502
- Status last verified
- Apr 2022
- First submitted
- 10 Apr 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Rational Drug Use Education Given To Parents On Parental Attitudes
- ClinicalTrials.gov ID
- NCT05331898
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/502
- Conditions
- Pediatric Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 19 Sep 2021 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Group | Experimental | Behavioral: Educationincrease the rational drug use of the parents. |
| control | No intervention | –PARENTS CANNOT USE RATIONAL MEDICATION ON THEIR CHILDREN |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being a 0-12 age group child
- Being literate
- Not having any communication problems
- Previous drug use for the child.
Key exclusion criteria (4 listed)
- 0-12 age group without children
- Being illiterate
- Having communication problems
- The child does not use drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educationthe education given increased the rational drug use of the parents. | Behavioural | Education Group |
Primary outcome
Parental Attitude Scale for Rational Drug Use
Time frame: 15 MONTHS
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: No. THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ARZU SARIALİOĞLU, PHD principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Pediatric Disorder, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Attitude Scale for Rational Drug Use (time frame: 15 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.