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Study of the Impact of a Pediatric Nurse's Consultation on Parental Anxiety During a Febrile Convulsion in Children

Study of the Impact of the Setting up of a Pediatric Nurse's Consultation on Parental Anxiety During a Febrile Convulsion in Children

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05947006
Acronym
CONSULFE
Enrollment
8
Registered
2023-07-14
Start date
2024-04-22
Completion date
2025-03-04
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Seizure

Keywords

anxiety, fever, convulsion, seizure, children

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.

Interventions

OTHERStandard care

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

OTHERCONSULFE consultation

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

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective, controlled, non-randomized single-center pilot study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Level of anxietyBaseline and 6 hours after the interventionChange 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.

Secondary

MeasureTime frameDescription
Parent's socio-economic positionBaselineSocio-economic position of parents measured by their level of study
Parent's level of anxiety at the departure of the emergency room6 hours after the interventionLevel 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.
Satisfaction of parents with intervention6 hours after the interventionSatisfaction 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
Parent's level of anxiety upon arrival on the emergency roomBaselineLevel 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.
Long term parent's level of post-traumatic stress1 month after the interventionPost-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
Cost of the intervention1 month after the interventionThe 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)
Long term parent's level of anxiety1 month after the interventionLevel 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026