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

Primary Purpose

Febrile Seizure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard care
CONSULFE consultation
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Febrile Seizure focused on measuring anxiety, fever, convulsion, seizure, children

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard care

    CONSULFE Consultation

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Parent's socio-economic position
    Socio-economic position of parents measured by their level of study
    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.
    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
    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.
    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
    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)

    Full Information

    First Posted
    June 19, 2023
    Last Updated
    July 12, 2023
    Sponsor
    University Hospital, Toulouse
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05947006
    Brief Title
    Study of the Impact of a Pediatric Nurse's Consultation on Parental Anxiety During a Febrile Convulsion in Children
    Acronym
    CONSULFE
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 13, 2023 (Anticipated)
    Primary Completion Date
    February 13, 2025 (Anticipated)
    Study Completion Date
    February 13, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Toulouse

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Febrile Seizure
    Keywords
    anxiety, fever, convulsion, seizure, children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, controlled, non-randomized single-center pilot study.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard care
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm will receive the standard care stablished in the emergency room after a febrile seizure
    Arm Title
    CONSULFE Consultation
    Arm Type
    Experimental
    Arm Description
    Patients in this arm will receive a consultation managed by the pediatric nurse (CONSULFE)
    Intervention Type
    Other
    Intervention Name(s)
    Standard care
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    CONSULFE consultation
    Other Intervention Name(s)
    Consultation managed by the pediatric nurse
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Level of anxiety
    Description
    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.
    Time Frame
    Baseline and 6 hours after the intervention
    Secondary Outcome Measure Information:
    Title
    Parent's level of anxiety upon arrival on the emergency room
    Description
    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.
    Time Frame
    Baseline
    Title
    Parent's socio-economic position
    Description
    Socio-economic position of parents measured by their level of study
    Time Frame
    Baseline
    Title
    Parent's level of anxiety at the departure of the emergency room
    Description
    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.
    Time Frame
    6 hours after the intervention
    Title
    Satisfaction of parents with intervention
    Description
    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
    Time Frame
    6 hours after the intervention
    Title
    Long term parent's level of anxiety
    Description
    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.
    Time Frame
    1 month after the intervention
    Title
    Long term parent's level of post-traumatic stress
    Description
    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
    Time Frame
    1 month after the intervention
    Title
    Cost of the intervention
    Description
    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)
    Time Frame
    1 month after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alex BRIGAND
    Phone
    05 34 55 84 11
    Email
    brigand.a@chu-toulouse.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alex BRIGAND
    Organizational Affiliation
    University Hospital, Toulouse
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23932660
    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.
    Results Reference
    background
    PubMed Identifier
    2058397
    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.
    Results Reference
    background
    PubMed Identifier
    18461360
    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.
    Results Reference
    background
    PubMed Identifier
    25952398
    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.
    Results Reference
    background
    PubMed Identifier
    30932454
    Citation
    Smith DK, Sadler KP, Benedum M. Febrile Seizures: Risks, Evaluation, and Prognosis. Am Fam Physician. 2019 Apr 1;99(7):445-450.
    Results Reference
    background
    PubMed Identifier
    17419783
    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.
    Results Reference
    background
    PubMed Identifier
    34144460
    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.
    Results Reference
    background

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