Clinical trial NCT05947006: Study of the Impact of a Pediatric Nurse's Consultation on Parental Anxiety During a Febrile Convulsion in Children
Official title: Study of the Impact of the Setting up of a Pediatric Nurse's Consultation on Parental Anxiety During a Febrile Convulsion in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Febrile Seizure
Keywords: anxiety
fever
convulsion
seizure
children
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, controlled, non-randomized single-center pilot study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participant being an adult parent who attended the febrile seizure of their child aged 1 to 5, episode lasting less than 15 minutes occurring within 24 hours
* Participant having signed the free and informed consent
* Affiliation to a social security scheme

Exclusion Criteria:

* Parent who already has experience of febrile seizures in one of the siblings
* Parent of a child with a convulsive or neurological history
* Non-French speaking parents
* Parent with a diagnosed psychiatric illness
* Parent benefiting from a legal protection measure
* Parent participating in a study related to the management of anxiety

Primary outcomes:
measure: Level of anxiety
timeFrame: Baseline and 6 hours after the intervention
Secondary outcomes:
measure: Parent's level of anxiety upon arrival on the emergency room
timeFrame: Baseline
measure: Parent's socio-economic position
timeFrame: Baseline
measure: Parent's level of anxiety at the departure of the emergency room
timeFrame: 6 hours after the intervention
measure: Satisfaction of parents with intervention
timeFrame: 6 hours after the intervention
measure: Long term parent's level of anxiety
timeFrame: 1 month after the intervention
measure: Long term parent's level of post-traumatic stress
timeFrame: 1 month after the intervention
measure: Cost of the intervention
timeFrame: 1 month after the intervention
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Alex BRIGAND
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Smith DK, Sadler KP, Benedum M. Febrile Seizures: Risks, Evaluation, and Prognosis. Am Fam Physician. 2019 Apr 1;99(7):445-450.
citation: 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.
citation: 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.