Febrile ConvulsionFKTNCT06676020
Effect of Febrile Convulsion Training on Anxiety and Knowledge
A study testing Nurse-delivered structured education in people with Febrile Convulsion, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The research will be conducted to determine the effect of the training given to parents/caregivers on their knowledge, attitudes, practices and anxiety towards preventing febrile seizures in children. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Febrile Convulsion
- What is being tested?
- Nurse-delivered structured education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2024to 30 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Referral to paediatric emergency department with febrile convulsion
- Children aged between 6 months and 5 years
- Voluntary participation of the child and his/her family in the study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF THE TRAINING GIVEN TO THE PARENTS OF CHILDREN WITH FEBRILE CONVULSION WHO COME TO THE PAEDIATRIC EMERGENCY DEPARTMENT ON THE ANXIETY AND KNOWLEDGE LEVEL OF THE PARENTS
The research will be conducted to determine the effect of the training given to parents/caregivers on their knowledge, attitudes, practices and anxiety towards preventing febrile seizures in children. The research will be carried out as a randomised controlled experimental design in the Pediatric Emergency Department of Zeynep Kamil Women's and Children's Diseases Training and Research Hospital between October 2024 and October 2025.
Read the detailed description
INTRODUCTION Febrile convulsion (FC) is defined as a type of seizure with fever in the absence of any 6 months to 5 years of age and is the most common neurological disorder of infants and young children. Although FC occurs in 2-4% of the entire paediatric population, 90% of cases occur between 6 months and 3 months of age. Simple FCs, defined as generalised seizures lasting less than 15 minutes, and represent the majority of febrile convulsions that do not recur within 24 hours. The risk of mortality and morbidity in FC is very low and there is no detectable brain damage associated with the disease. Complications of febrile seizures in children include psychosocial effects, cognitive deficits, hospital bed occupancy, prolonged hospitalisation and increased healthcare costs. In a 12-year follow-up of neurological complications from febrile seizures, delayed neurological development and abnormalities were found in 20% of children, neurological deficits in 10% and learning disabilities in 5%. Simple measures such as controlling fever, washing feet and using antipyretics can prevent the incidence of the disease and febrile seizure complications in children. Due to the concurrent relatively high prevalence of this disease in children, the occurrence of two important phenomena, such as fever and seizures, causes severe anxiety to parents and may impair the quality of life of the family. Informing parents by providing adequate knowledge and awareness about fever and seizures is an important step in reducing anxieties and worries. In a study conducted by Sheringham on 154 parents with children in febrile seizures, 54.3% of individuals receiving training had appropriate knowledge and there was a direct correlation between parents' knowledge and practice. In Flury's study, 91% of parents experienced severe anxiety when faced with febrile seizures, and the intensity of anxiety was significantly higher in untrained individuals than in trained individuals. Parmer, in a study of 140 parents with children who had febrile seizures in India, noted that 59.3% of parents were not aware of this disease and only 20% knew the normal values of body temperature. Education of parents was emphasised in the study. In the literature, the number of studies aiming to determine the level of knowledge by providing education to families of children hospitalised with FC is insufficient. Therefore, in the light of the literature, the study will be conducted to determine the impact of education given to parents/carers due to their knowledge, attitudes, practices and concerns in the prevention of febrile seizures in children.
- Conditions
- Febrile Convulsion
- Being tested
- Nurse-delivered structured education
- Keywords
- Febrile convulsion, EDUCATION, anxiety, knowledge level
- Medical subject headings
- Seizures, Febrile, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-delivered structured educationBehavioural
A single approximately 15-minute individual education session delivered by a pediatric emergency nurse, following the Febrile Convulsion Family Handbook prepared by the Division of Child Neurology, Department of Pediatrics, Ege University Faculty of Medicine (Izmir, Türkiye) as a fixed script. Content covered the nature of febrile convulsion, fever measurement and management, antipyretic use, seizure first aid, and rectal diazepam use when prescribed. A printed copy of the handbook was given to the parent. The handbook was publicly available through the Turkish Child Neurology Society website during the study.
| Study group | Role | What they receive |
|---|---|---|
| Structured education | Experimental | Routine clinical education plus a single 15-minute face-to-face structured education session delivered at the bedside by a pediatric emergency nurse, based on the Febrile Convulsion Family Handbook prepared by the Division of Child Neurology, Department of Pediatrics, Ege University Faculty of Medicine (Izmir, Türkiye), which was publicly available through the Turkish Child Neurology Society website during the study. Receives: Behavioral: Nurse-delivered structured education |
| Routine education | No intervention | Routine clinical education alone (brief, unstructured verbal information from the attending clinician). The handbook was provided after the final 1-month assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HAD)
Hospital Anxiety and Depression Scale (HAD) The scale is a four-point Likert-type assessment tool, and the scores of its items range from 0 to 3. However, each item is scored differently; items 1, 3, 5, 6, 8, 10, 11, and 13 show decreasing severity and are scored as 3, 2, 1, 0. On the other hand, items 2, 4, 7, 9, 12, and 14 are scored as 0, 1, 2, 3. The total scores of the subscales are obtained by adding the scores of these items. For the anxiety subscale, items 1, 3, 5, 7, 9, 11 and 13 are added; for the depression subscale, items 2, 4, 6, 8, 10, 12 and 14 are added.
Measured: one year
Febrile Convulsion Knowledge Scale
Febrile Convulsion Knowledge Scale for Parents/Caregivers: In the febrile convulsion knowledge scale, items 1 and 4 are correct statements and the other items are incorrect statements. Incorrect statements should be reversed and calculated when scoring. The total score of the scale varies between 8 and 40, and higher scores indicate that parents/caregivers have more knowledge about febrile convulsions.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start30 Nov 2024
- Primary completion30 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Febrile ConvulsionStudies 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
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba KARAKUS TURKER, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676020
- Sponsor's protocol ID
- UskudarUU
- Acronym
- FKT
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang MC, Huang CC, Thomas K. Febrile convulsions: development and validation of a questionnaire to measure parental knowledge, attitudes, concerns and practices. J Formos Med Assoc. 2006 Jan;105(1):38-48. doi: 10.1016/S0929-6646(09)60107-8.
PubMed 16440069Jones T, Jacobsen SJ. Childhood febrile seizures: overview and implications. Int J Med Sci. 2007 Apr 7;4(2):110-4. doi: 10.7150/ijms.4.110.
PubMed 17479160MacDonald BK, Johnson AL, Sander JW, Shorvon SD. Febrile convulsions in 220 children--neurological sequelae at 12 years follow-up. Eur Neurol. 1999;41(4):179-86. doi: 10.1159/000008048.
PubMed 10343147Verity CM, Greenwood R, Golding J. Long-term intellectual and behavioral outcomes of children with febrile convulsions. N Engl J Med. 1998 Jun 11;338(24):1723-8. doi: 10.1056/NEJM199806113382403.
PubMed 9624192Mohsen S, Mahboobeh SH: The effect of education based on health belief model (HBM) in mothers about behaviour of prevention from febrile convulsion in children. World J Med Sci. 2013, 9:30-5. 10.5829/idosi.wjms.2013.9.1.7617
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF THE TRAINING GIVEN TO THE PARENTS OF CHILDREN WITH FEBRILE CONVULSION WHO COME TO THE PAEDIATRIC EMERGENCY DEPARTMENT ON THE ANXIETY AND KNOWLEDGE LEVEL OF THE PARENTS
- ClinicalTrials.gov ID
- NCT06676020
- Acronym / sponsor ID
- FKT / UskudarUU
- Conditions
- Febrile Convulsion
- Keywords
- Febrile convulsion, EDUCATION, anxiety, knowledge level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 6 Nov 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.
The research will be conducted to determine the effect of the training given to parents/caregivers on their knowledge, attitudes, practices and anxiety towards preventing febrile seizures in children. The research will be carried out as a randomised controlled experimental design in the Pediatric Emergency Department of Zeynep Kamil Women's and Children's Diseases Training and Research Hospital between October 2024 and October 2025.
Detailed description
INTRODUCTION Febrile convulsion (FC) is defined as a type of seizure with fever in the absence of any 6 months to 5 years of age and is the most common neurological disorder of infants and young children. Although FC occurs in 2-4% of the entire paediatric population, 90% of cases occur between 6 months and 3 months of age. Simple FCs, defined as generalised seizures lasting less than 15 minutes, and represent the majority of febrile convulsions that do not recur within 24 hours. The risk of mortality and morbidity in FC is very low and there is no detectable brain damage associated with the disease. Complications of febrile seizures in children include psychosocial effects, cognitive deficits, hospital bed occupancy, prolonged hospitalisation and increased healthcare costs. In a 12-year follow-up of neurological complications from febrile seizures, delayed neurological development and abnormalities were found in 20% of children, neurological deficits in 10% and learning disabilities in 5%. Simple measures such as controlling fever, washing feet and using antipyretics can prevent the incidence of the disease and febrile seizure complications in children. Due to the concurrent relatively high prevalence of this disease in children, the occurrence of two important phenomena, such as fever and seizures, causes severe anxiety to parents and may impair the quality of life of the family. Informing parents by providing adequate knowledge and awareness about fever and seizures is an important step in reducing anxieties and worries. In a study conducted by Sheringham on 154 parents with children in febrile seizures, 54.3% of individuals receiving training had appropriate knowledge and there was a direct correlation between parents' knowledge and practice. In Flury's study, 91% of parents experienced severe anxiety when faced with febrile seizures, and the intensity of anxiety was significantly higher in untrained individuals than in trained individuals. Parmer, in a study of 140 parents with children who had febrile seizures in India, noted that 59.3% of parents were not aware of this disease and only 20% knew the normal values of body temperature. Education of parents was emphasised in the study. In the literature, the number of studies aiming to determine the level of knowledge by providing education to families of children hospitalised with FC is insufficient. Therefore, in the light of the literature, the study will be conducted to determine the impact of education given to parents/carers due to their knowledge, attitudes, practices and concerns in the prevention of febrile seizures in children.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured education | Experimental | Behavioral: Nurse-delivered structured educationRoutine clinical education plus a single 15-minute face-to-face structured education session delivered at the bedside by a pediatric emergency nurse, based on the Febrile Convulsion Family Handbook prepared by the Division of Child Neurology, Department of Pediatrics, Ege University Faculty of Medicine (Izmir, Türkiye), which was publicly available through the Turkish Child Neurology Society website during the study. |
| Routine education | No intervention | –Routine clinical education alone (brief, unstructured verbal information from the attending clinician). The handbook was provided after the final 1-month assessment |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Referral to paediatric emergency department with febrile convulsion
- Children aged between 6 months and 5 years
- Voluntary participation of the child and his/her family in the study.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Nurse-delivered structured educationA single approximately 15-minute individual education session delivered by a pediatric emergency nurse, following the Febrile Convulsion Family Handbook prepared by the Division of Child Neurology, Department of Pediatrics, Ege University Faculty of Medicine (Izmir, Türkiye) as a fixed script. Content covered the nature of febrile convulsion, fever measurement and management, antipyretic use, seizure first aid, and rectal diazepam use when prescribed. A printed copy of the handbook was given to the parent. The handbook was publicly available through the Turkish Child Neurology Society website during the study. | Behavioural | Structured education |
Primary outcome
Hospital Anxiety and Depression Scale (HAD)
Time frame: one year
Hospital Anxiety and Depression Scale (HAD) The scale is a four-point Likert-type assessment tool, and the scores of its items range from 0 to 3. However, each item is scored differently; items 1, 3, 5, 6, 8, 10, 11, and 13 show decreasing severity and are scored as 3, 2, 1, 0. On the other hand, items 2, 4, 7, 9, 12, and 14 are scored as 0, 1, 2, 3. The total scores of the subscales are obtained by adding the scores of these items. For the anxiety subscale, items 1, 3, 5, 7, 9, 11 and 13 are added; for the depression subscale, items 2, 4, 6, 8, 10, 12 and 14 are added.
Febrile Convulsion Knowledge Scale
Time frame: one year
Febrile Convulsion Knowledge Scale for Parents/Caregivers: In the febrile convulsion knowledge scale, items 1 and 4 are correct statements and the other items are incorrect statements. Incorrect statements should be reversed and calculated when scoring. The total score of the scale varies between 8 and 40, and higher scores indicate that parents/caregivers have more knowledge about febrile convulsions.
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 14 Sep 2026.
- Background: PubMed 16440069Huang MC, Huang CC, Thomas K. Febrile convulsions: development and validation of a questionnaire to measure parental knowledge, attitudes, concerns and practices. J Formos Med Assoc. 2006 Jan;105(1):38-48. doi: 10.1016/S0929-6646(09)60107-8.
- Background: PubMed 17479160Jones T, Jacobsen SJ. Childhood febrile seizures: overview and implications. Int J Med Sci. 2007 Apr 7;4(2):110-4. doi: 10.7150/ijms.4.110.
- Background: PubMed 10343147MacDonald BK, Johnson AL, Sander JW, Shorvon SD. Febrile convulsions in 220 children--neurological sequelae at 12 years follow-up. Eur Neurol. 1999;41(4):179-86. doi: 10.1159/000008048.
- Background: PubMed 9624192Verity CM, Greenwood R, Golding J. Long-term intellectual and behavioral outcomes of children with febrile convulsions. N Engl J Med. 1998 Jun 11;338(24):1723-8. doi: 10.1056/NEJM199806113382403.
- BackgroundMohsen S, Mahboobeh SH: The effect of education based on health belief model (HBM) in mothers about behaviour of prevention from febrile convulsion in children. World J Med Sci. 2013, 9:30-5. 10.5829/idosi.wjms.2013.9.1.7617
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-delivered structured education in people with Febrile Convulsion, run by Uskudar 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 3 inclusion and 1 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 14 Sep 2026. 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?
Hospital Anxiety and Depression Scale (HAD) (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06676020, which also lists 5 linked publications.
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 14 Sep 2026.