FeverNCT06599853
Fever Education Given to Parents of Children Presenting to the Emergency Department With Fever
A study testing Fever Education in people with Fever, run by Merve YETİMOĞLU at 3 sites in Turkey (Türkiye).
Trial summary
Fever is a common symptom of childhood, especially between the ages of one and five, and is the main reason for emergency room visits. These emergency room visits are due to parents incorrect information and practices regarding fever management. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fever
- What is being tested?
- Fever Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Nov 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having a child between the ages of 1-5
- Able to read, understand and have no problems speaking Turkish
- Having a green triage code in the emergency room triage application
Who cannot join
- Children diagnosed with or receiving treatment for chronic diseases
- Children with a history of febrile convulsions
- Children dependent on home mechanical ventilation
- Parents with psychiatric diagnoses will be excluded from the study
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Karadeniz Technical University Faculty of Medicine Pediatric Emergency Unit
Trabzon, Kanuni Campus, 61080
MERVE YETİMOĞLU, +9 0531 813 31 35, merveyetimoglu0@gmail.com
- Recruiting
Karadeniz Technical University Faculty of Medicine Pediatric Emergency Unit
Trabzon, 61080
Ahmet Kağan OZKAYA, Doç.Dr., +90 462 377 1175, akozkaya@ktu.edu.tr
- Recruiting
Karadeniz Technical University Faculty of Medicine Pediatric Emergency Unit
Trabzon, 61080
About this study
Official title: Evaluation of the Effect of Fever Education Given to Parents of Children Presenting to the Emergency Department With Fever on Parental Anxiety Level and Fever Management
Fever is a common symptom of childhood, especially between the ages of one and five, and is the main reason for emergency room visits. These emergency room visits are due to parents incorrect information and practices regarding fever management. This situation causes an increase in parental anxiety and failure to provide fever management. In line with this information, this study was planned to evaluate the effects of education given to parents of children presenting to the emergency room with fever on parental anxiety level and fever management.
Read the detailed description
Fever is a common symptom in childhood and is the main reason for emergency room visits. The rate of children applying to the emergency department due to fever in our country is quite high compared to the rest of the world. Parents misinformation and practices regarding fever increase parental anxiety levels and negatively affect fever management. Interventional studies aimed at reducing parents anxiety levels and ensuring fever management are quite limited. This research will evaluate the effect of fever education given to parents on their anxiety levels and fever management.
The research was planned as a randomized controlled study with experimental and control groups. The research will be carried out between April 2024 and April 2025. After the power analysis of the sample, a total of 80 people will be included in the sample, 40 in the experimental group and 40 in the control group. Parents in the experimental group will be given fever training, while parents in the control group will not receive any treatment. Data will be collected with Parent-Child Introductory Information Form, State Anxiety Scale, Parent Fever Management Scale, Visual Analogue Scale (VAS)- Satisfaction with Fever Education Practice Scale and Parent-Education Satisfaction Form Scale. The data will be pre-tested, post-tested 1 month after the training, and permanence tested 3 months after the training, and the research will be terminated. Generalised linear models analysis, robust ANOVA, independent samples t test, Mann Whitney U and chi-square analysis will be used in the evaluation of the data. Mean, s.deviation, median, minimum and maximum will be used for quantitative data and frequency and percentage will be used for categorical data.As a result of the research, it is expected that fever education given to parents will positively affect parental anxiety level and fever management.
- Conditions
- Fever
- Being tested
- Fever Education
- Keywords
- Emergency, Fever, Parents, Education, Child, Anxiety
- Medical subject headings
- Fever, Emergencies, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fever EducationOther
Also called It is planned to conduct a survey with the first post-test and a retention test 3 months after the training is given to the parents.
Another aspect of this research that is different from other studies is that a retention test will be applied to the participants after the pre-test and post-test, and the long-term effect of the training given will be examined. In this direction, it is aimed to reduce the inappropriate use of emergency services, the use of unnecessary tests and the increasing health system costs. It is aimed to prevent crowding in the emergency department by reducing the inappropriate use of emergency services.
| Study group | Role | What they receive |
|---|---|---|
| Group to be trained | Experimental | Parents in the experimental group were randomly assigned. Parents in the experimental group will be trained with parent fever management training material via home visits. Repeated measurements will be made one month after the training and at 3 months. Parent fever management training material was created by the researcher according to the literature. Opinions of experts in the field were obtained for the suitability of the training booklet. Receives: Other: Fever Education |
| Control group | No intervention | No intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
This form was prepared by the researcher in line with the literature. This form consists of three sections. The parent sociodemographic form, the child sociodemographic form and the form, which includes questions on parental fever-related knowledge and practices, consists of a total of 35 questions.
Measured: one months
State/Trait Anxiety Inventory (SAI)
The scale was developed by Spielber and others in 1964 to determine anxiety levels. The Turkish validity and reliability of the scale was carried out by Öner and Le Compte in 1985. The scale provides information about what is felt at that moment and consists of 20 items in Likert type, scored from 1 to 4. 1 is not at all, 2 is a little, 3 is very much and 4 is completely agree, and the individual marks one of these. A value of 1 indicates high anxiety, while a value of 4 indicates low anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 in the SAI are reversed. When calculating the scale score, the total score of the reversed items is subtracted from the total of the correct statements and a fixed score of 50 is added to this number. The total score obtained from the scale varies between 20 and 80. As the score increases, it indicates that anxiety is high, and as the score decreases, it indicates that anxiety decreases.
Measured: one months
Parental Fever Management Scale-Turkish Version (PFMS-TR)
The scale was developed by Walsh and Edwards in 2008 to assess parents' fever management practices. The Turkish validity and reliability of the scale was conducted by Cınar et al. in 2013. The scale consists of 8 items and is a Likert-type scale with items rated as "(1) never, (2) rarely, (3) sometimes, (4) often, (5) always". The lowest possible score for the scale is 8 and the highest is 40. A higher score indicates more fever management practices, and a lower score indicates less fever management practices. The Cronbach Alpha reliability coefficient of the scale is 0.75.
Measured: one months
Secondary outcomes (5)
State/Trait Anxiety Inventory (SAI)
The scale was developed by Spielber and others in 1964 to determine anxiety levels. The Turkish validity and reliability of the scale was carried out by Öner and Le Compte in 1985. The scale provides information about what is felt at that moment and consists of 20 items on a Likert-type scale scored from 1 to 4. 1 is not at all, 2 is a little, 3 is very much, and 4 is completely agree, and the individual marks one of these. A value of 1 indicates high anxiety, while a value of 4 indicates low anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 on the SAI are reversed. When calculating the scale score, the total score of the reversed items is subtracted from the total of the correct statements and a fixed score of 50 is added to this number. The total score obtained from the scale varies between 20 and 80. As the score increases, it indicates that anxiety is high, and as the score decreases, it indicates that anxiety decreases.
Measured: three months
Visual Analog Scale (VAS) - Satisfaction Scale for Fire Education Application
The scale was developed by Hayes and Patterson in 1921 and is a scale used to measure some expressions with numbers. Two expressions to be evaluated on a straight line are at two extreme points. The line contains numbers from 1 to 10. The participant is asked to mark the point that describes his/her own situation. It was planned to measure satisfaction with the fire education application by taking the Visual Analog Scale as an example. I am not satisfied at one end of the line, and I am very satisfied at the other end, and the parent will be asked to evaluate his/her situation.
Measured: three months
Parental Fever Management Scale-Turkish Version (PFMS-TR)
The scale was developed by Walsh and Edwards in 2008 to assess what parents do in fever management. The Turkish validity and reliability of the scale was carried out by Cınar et al. in 2013. The scale consists of 8 items and is a Likert-type scale where the items are graded as "(1) never, (2) rarely, (3) sometimes, (4) often, (5) always". The lowest possible score for the scale is 8 and the highest is 40. A higher score indicates that more fever management practices are being implemented, and a lower score indicates that fewer fever management practices are being implemented. The Cronbach Alpha reliability coefficient of the scale is 0.75.
Measured: three months
Parental Fever Management Scale-Turkish Version (PFMS-TR)
The scale was developed by Walsh and Edwards in 2008 to assess what parents do in fever management. The Turkish validity and reliability of the scale was carried out by Cınar et al. in 2013. The scale consists of 8 items and is a Likert-type scale where the items are graded as "(1) never, (2) rarely, (3) sometimes, (4) often, (5) always". The lowest possible score for the scale is 8 and the highest is 40. A higher score indicates that more fever management practices are being implemented, and a lower score indicates that fewer fever management practices are being implemented. The Cronbach Alpha reliability coefficient of the scale is 0.75.
Measured: two months
State/Trait Anxiety Inventory (SAI)
The scale was developed by Spielber et al. in 1964 to determine the level of anxiety. The Turkish validity and reliability of the scale was carried out by Öner and Le Compte in 1985. The scale provides information about what is felt at that moment and consists of 20 Likert-type items scored from 1 to 4. 1 is not at all, 2 is a little, 3 is very much and 4 is completely agree, and the individual marks one of these. A value of 1 indicates high anxiety, while a value of 4 indicates low anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 in the SAI are reversed. When calculating the scale score, the total score of the reversed items is subtracted from the total of the correct statements and a fixed score of 50 is added to this number. The total score obtained from the scale varies between 20 and 80. A higher score indicates that anxiety is high, and a lower score indicates that anxiety is decreasing.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Apr 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research was planned as a randomized controlled study with experimental and control groups.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merve YETİMOĞLU
- Sponsor type
- University, hospital or other
- Collaborators
- Karadeniz Technical University
- Responsible party
- Sponsor-investigator, Merve YETİMOĞLU, Karadeniz Technical University
- Investigators
- Merve YETİMOĞLU, Nursing, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599853
- Sponsor's protocol ID
- KaradenizTU-SBF-MY-01
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Fever Education Given to Parents of Children Presenting to the Emergency Department With Fever on Parental Anxiety Level and Fever Management
- ClinicalTrials.gov ID
- NCT06599853
- Acronym / sponsor ID
- KaradenizTU-SBF-MY-01
- Conditions
- Fever
- Keywords
- Emergency, Fever, Parents, Education, Child, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Merve YETİMOĞLUUniversity, hospital or other
- Collaborators
- Karadeniz Technical University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
Fever is a common symptom of childhood, especially between the ages of one and five, and is the main reason for emergency room visits. These emergency room visits are due to parents incorrect information and practices regarding fever management. This situation causes an increase in parental anxiety and failure to provide fever management. In line with this information, this study was planned to evaluate the effects of education given to parents of children presenting to the emergency room with fever on parental anxiety level and fever management.
Detailed description
Fever is a common symptom in childhood and is the main reason for emergency room visits. The rate of children applying to the emergency department due to fever in our country is quite high compared to the rest of the world. Parents misinformation and practices regarding fever increase parental anxiety levels and negatively affect fever management. Interventional studies aimed at reducing parents anxiety levels and ensuring fever management are quite limited. This research will evaluate the effect of fever education given to parents on their anxiety levels and fever management.
The research was planned as a randomized controlled study with experimental and control groups. The research will be carried out between April 2024 and April 2025. After the power analysis of the sample, a total of 80 people will be included in the sample, 40 in the experimental group and 40 in the control group. Parents in the experimental group will be given fever training, while parents in the control group will not receive any treatment. Data will be collected with Parent-Child Introductory Information Form, State Anxiety Scale, Parent Fever Management Scale, Visual Analogue Scale (VAS)- Satisfaction with Fever Education Practice Scale and Parent-Education Satisfaction Form Scale. The data will be pre-tested, post-tested 1 month after the training, and permanence tested 3 months after the training, and the research will be terminated. Generalised linear models analysis, robust ANOVA, independent samples t test, Mann Whitney U and chi-square analysis will be used in the evaluation of the data. Mean, s.deviation, median, minimum and maximum will be used for quantitative data and frequency and percentage will be used for categorical data.As a result of the research, it is expected that fever education given to parents will positively affect parental anxiety level and fever management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research was planned as a randomized controlled study with experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Group to be trained | Experimental | Other: Fever EducationParents in the experimental group were randomly assigned. Parents in the experimental group will be trained with parent fever management training material via home visits. Repeated measurements will be made one month after the training and at 3 months. Parent fever management training material was created by the researcher according to the literature. Opinions of experts in the field were obtained for the suitability of the training booklet. |
| Control group | No intervention | –No intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Having a child between the ages of 1-5
- Able to read, understand and have no problems speaking Turkish
- Having a green triage code in the emergency room triage application
Key exclusion criteria (4 listed)
- Children diagnosed with or receiving treatment for chronic diseases
- Children with a history of febrile convulsions
- Children dependent on home mechanical ventilation
- Parents with psychiatric diagnoses will be excluded from the study
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 |
|---|---|---|
| Fever EducationAlso: It is planned to conduct a survey with the first post-test and a retention test 3 months after the training is given to the parents.Another aspect of this research that is different from other studies is that a retention test will be applied to the participants after the pre-test and post-test, and the long-term effect of the training given will be examined. In this direction, it is aimed to reduce the inappropriate use of emergency services, the use of unnecessary tests and the increasing health system costs. It is aimed to prevent crowding in the emergency department by reducing the inappropriate use of emergency services. | Other | Group to be trained |
Primary outcome
Introductory Information Form
Time frame: one months
This form was prepared by the researcher in line with the literature. This form consists of three sections. The parent sociodemographic form, the child sociodemographic form and the form, which includes questions on parental fever-related knowledge and practices, consists of a total of 35 questions.
State/Trait Anxiety Inventory (SAI)
Time frame: one months
The scale was developed by Spielber and others in 1964 to determine anxiety levels. The Turkish validity and reliability of the scale was carried out by Öner and Le Compte in 1985. The scale provides information about what is felt at that moment and consists of 20 items in Likert type, scored from 1 to 4. 1 is not at all, 2 is a little, 3 is very much and 4 is completely agree, and the individual marks one of these. A value of 1 indicates high anxiety, while a value of 4 indicates low anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 in the SAI are reversed. When calculating the scale score, the total score of the reversed items is subtracted from the total of the correct statements and a fixed score of 50 is added to this number. The total score obtained from the scale varies between 20 and 80. As the score increases, it indicates that anxiety is high, and as the score decreases, it indicates that anxiety decreases.
Parental Fever Management Scale-Turkish Version (PFMS-TR)
Time frame: one months
The scale was developed by Walsh and Edwards in 2008 to assess parents' fever management practices. The Turkish validity and reliability of the scale was conducted by Cınar et al. in 2013. The scale consists of 8 items and is a Likert-type scale with items rated as "(1) never, (2) rarely, (3) sometimes, (4) often, (5) always". The lowest possible score for the scale is 8 and the highest is 40. A higher score indicates more fever management practices, and a lower score indicates less fever management practices. The Cronbach Alpha reliability coefficient of the scale is 0.75.
5 secondary outcomes
State/Trait Anxiety Inventory (SAI)
Time frame: three months
Visual Analog Scale (VAS) - Satisfaction Scale for Fire Education Application
Time frame: three months
Parental Fever Management Scale-Turkish Version (PFMS-TR)
Time frame: three months
Parental Fever Management Scale-Turkish Version (PFMS-TR)
Time frame: two months
State/Trait Anxiety Inventory (SAI)
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Merve YETİMOĞLU, Nursing principal investigator
Karadeniz Technical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fever Education in people with Fever, run by Merve YETİMOĞLU at 3 sites 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 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact merve yetimoğlu, Nursing (531-813-3135, merveyetimoglu0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: one months). The study lists 3 primary outcomes in all. 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 19 Sep 2024.