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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Febrile Seizure
• Intervention / Treatment: Other: Standard care; Other: CONSULFE consultation

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex BRIGAND; Phone Number: 05 34 55 84 11; Email: brigand.a@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care; Patients in this arm will receive the standard care stablished in the emergency room after a febrile seizure	Other: Standard 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
Experimental: CONSULFE Consultation; Patients in this arm will receive a consultation managed by the pediatric nurse (CONSULFE)	Other: CONSULFE 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; Other Names: Consultation managed by the pediatric nurse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Alex BRIGAND, University Hospital, Toulouse

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Smith DK, Sadler KP, Benedum M. Febrile Seizures: Risks, Evaluation, and Prognosis. Am Fam Physician. 2019 Apr 1;99(7):445-450.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 13, 2023
• Primary Completion (Estimated): February 13, 2025
• Study Completion (Estimated): February 13, 2025

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: children; fever; anxiety; seizure; convulsion
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Seizures; Hyperthermia; Fever; Seizures, Febrile
• Other Study ID Numbers: RC31/22/0484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No