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Investigator changed departments, parents refused to participate in the study
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Febrile seizures are considered a very common syndrome presented in the pediatric emergency room. Witnessing these seizures may can cause anxiety in parents and generate them psychological sequelae such as major depressive disorder in the short term, or sleep disorders in the long term.
An appropriate care for parents must be put in place in the emergency department, with the objective of improving their knowledge of this pathology and its care, and thus to reduce their anxiety and prevent potential inappropriate or even deleterious behavior and maneuvers towards the child.
Febrile seizures occupy a large place in pediatric practice in the emergency room, their prevalence varies between 3 and 8% in children under 7 years old, hence the notion of a very common syndrome.
When parents witness this event, they can experience it as terrifying, and which can alone cause anxiety and generate psychological sequelae. In the literature, it is described that a third of the parents present a major depressive disorder after the event and a third of the parents still describe sleep disorders after one year.
After the arrival at the pediatric emergency room following the febrile seizure, the priority is given to the care of the child and parents are given succinct medical information. Due to parental anxiety, which may still be significant at this time, this information may not be understood. All of this can make the parent's level of knowledge about this pathology and its management low, potentially leading to future behaviors and maneuvers (such as shaking) that are inappropriate or even harmful to the child.
A different course with appropriate care for parents must be put in place in the emergency department, with the objective of improving their knowledge of this pathology, its care and to reduce parent's anxiety. This is why the CONSULFE childcare consultation is proposed in this research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator | Patients in this arm will receive the standard care stablished in the emergency room after a febrile seizure |
|
| CONSULFE Consultation | Experimental | Patients in this arm will receive a consultation managed by the pediatric nurse (CONSULFE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care | Other | Patients in this arm will receive the standard care stablished in the emergency room after a febrile seizure, consisting of a medical assessment of the child, followed by 6 hours of supervision of the child and his parent in the waiting room, a reassessment of the child by the doctor, and finally they can return home |
| Measure | Description | Time Frame |
|---|---|---|
| Level of anxiety | Change in the level of anxiety felt at the beginning and at the end of the visit to the emergency room by parents during standard treatment vs parents following the CONSULFE consultation. The level of anxiety is measured with the State-Trait Anxiety Inventory (STAI), with a minimum value of 20, meaning no or low anxiety, and a maximum value of 80, meaning high anxiety. | Baseline and 6 hours after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Parent's level of anxiety upon arrival on the emergency room | Level of anxiety measured by the State-Trait Anxiety Inventory (STAI), with a minimum value of 20, meaning no or low anxiety, and a maximum value of 80, meaning high anxiety. | Baseline |
| Parent's socio-economic position |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex BRIGAND | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Toulouse | Toulouse | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23932660 | Background | Tison-Chambellan C, Fine A, Cances C, Chaix Y, Claudet I. [Anthropological approach to current parental perceptions of children's seizures]. Arch Pediatr. 2013 Oct;20(10):1075-82. doi: 10.1016/j.arcped.2013.07.001. Epub 2013 Aug 7. French. | |
| 2058397 | Background | Balslev T. Parental reactions to a child's first febrile convulsion. A follow-up investigation. Acta Paediatr Scand. 1991 Apr;80(4):466-9. doi: 10.1111/j.1651-2227.1991.tb11883.x. |
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| ID | Term |
|---|---|
| D003294 | Seizures, Febrile |
| D001008 | Anxiety Disorders |
| D005334 | Fever |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Prospective, controlled, non-randomized single-center pilot study.
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|
| CONSULFE consultation | Other | In addition to the standard care, patients in this arm will receive a consultation managed by the pediatric nurse (CONSULFE) during the 6 hour supervision time in the waiting room |
|
|
Socio-economic position of parents measured by their level of study |
| Baseline |
| Parent's level of anxiety at the departure of the emergency room | Level of anxiety measured by the State-Trait Anxiety Inventory (STAI), with a minimum value of 20, meaning no or low anxiety, and a maximum value of 80, meaning high anxiety. | 6 hours after the intervention |
| Satisfaction of parents with intervention | Satisfaction with the intervention will be measured using a satisfaction questionnaire with values between 1 and 4, 1 meaning completely satisfied, and 4 meaning not satisfied | 6 hours after the intervention |
| Long term parent's level of anxiety | Level of anxiety measured by the State-Trait Anxiety Inventory (STAI), with a minimum value of 20, meaning no or low anxiety, and a maximum value of 80, meaning high anxiety. | 1 month after the intervention |
| Long term parent's level of post-traumatic stress | Post-traumatic stress (PTSD) measured by the IMPACT OF EVENTS SCALE-Revised (IES-R), with a minimum value of 0, meaning no PTSD, and a maximum value of 88, meaning PTSD is high enough to suppress your immune system's functioning | 1 month after the intervention |
| Cost of the intervention | The costs will be estimated according to two perspectives : from the hospital point of view (time spent by the childcare nurse), and from the health insurance point of view (number of consultations and visits to the emergency room) | 1 month after the intervention |
| 18461360 | Background | Kolahi AA, Tahmooreszadeh S. First febrile convulsions: inquiry about the knowledge, attitudes and concerns of the patients' mothers. Eur J Pediatr. 2009 Feb;168(2):167-71. doi: 10.1007/s00431-008-0724-z. Epub 2008 May 7. |
| 25952398 | Background | Paul SP, Rogers E, Wilkinson R, Paul B. Management of febrile convulsion in children. Emerg Nurse. 2015 May;23(2):18-25. doi: 10.7748/en.23.2.18.e1431. |
| 30932454 | Background | Smith DK, Sadler KP, Benedum M. Febrile Seizures: Risks, Evaluation, and Prognosis. Am Fam Physician. 2019 Apr 1;99(7):445-450. |
| 17419783 | Background | Walsh A, Edwards H, Fraser J. Influences on parents' fever management: beliefs, experiences and information sources. J Clin Nurs. 2007 Dec;16(12):2331-40. doi: 10.1111/j.1365-2702.2006.01890.x. Epub 2007 Apr 5. |
| 34144460 | Background | Klotz KA, Ozcan J, Sag Y, Schonberger J, Kaier K, Jacobs J. Anxiety of families after first unprovoked or first febrile seizure - A prospective, randomized pilot study. Epilepsy Behav. 2021 Sep;122:108120. doi: 10.1016/j.yebeh.2021.108120. Epub 2021 Jun 15. |
| D001523 | Mental Disorders |
| D001832 | Body Temperature Changes |