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

NCT05947006 | Terminated

• 1 other identifier: RC31/22/0484
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Febrile Seizure

Keywords

anxiety; fever; convulsion; seizure; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Parent's level of anxiety upon arrival on the emergency room

  Baseline

• Parent's socio-economic position

  Baseline

• Parent's level of anxiety at the departure of the emergency room

  6 hours after the intervention

• Satisfaction of parents with intervention

  6 hours after the intervention

• Long term parent's level of anxiety

  1 month after the intervention

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Patients in this arm will receive the standard care stablished in the emergency room after a febrile seizure

Other: Standard care

CONSULFE Consultation

EXPERIMENTAL

Patients in this arm will receive a consultation managed by the pediatric nurse (CONSULFE)

Other: CONSULFE consultation

Interventions

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

Standard care

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

Also known as: Consultation managed by the pediatric nurse

CONSULFE Consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

Related Publications (7)

• 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.

  PMID: 23932660 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.

  PMID: 2058397 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.

  PMID: 18461360 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.

  PMID: 25952398 BACKGROUND

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

  PMID: 30932454 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.

  PMID: 17419783 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.

  PMID: 34144460 BACKGROUND

MeSH Terms

Conditions

Seizures, Febrile; Anxiety Disorders; Fever; Seizures

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Body Temperature Changes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alex BRIGAND

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, controlled, non-randomized single-center pilot study.

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 14, 2023
• Study Start: April 22, 2024
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)