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The Visiting Child and His Family in ICU (ENVIFAR)

Primary Purpose

Intensive Care, Child, Acute Stress Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
interview
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intensive Care focused on measuring ICU, acute stress, PTSD, child, parent hospitalized

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • family groups in which at least one child aged 6 to 14 years having expressed the wish to visit his/her hospitalized relative
  • family groups in which the non-hospitalized parent has expressed the wish to accompany his/her child during the visit
  • parent hospitalized in ICU is at least 18 years old
  • informed consent of children, non-hospitalized and/or hospitalized relatives
  • informed consent of the accompanying caregiver

Exclusion Criteria:

  • moribund patient
  • child unaccompanied by his/her parent/relative during the visit
  • non-hospitalized non-French-speaking parent/relative (need to be able to answer the questionnaires)
  • child benefiting from a psychological follow-up prior to the hospitalization of his/her parent
  • non French-speaking child
  • child under 6 years old or older than 14
  • hospitalized relative who died before the proposed interview with the child (particular attention will be carry out to the interview conditions. The loss of the hospitalized parent will not allow for an interview on the experience of the visit).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Expérimental

    Arm Description

    psychologist interview and psychometrics scales

    Outcomes

    Primary Outcome Measures

    Acute psychotraumatic impact of the visit on the child
    Scale of stress (Child IES-R : Impact of Event Scale- Revised) : score calculated on 40 points. A score of 17 or greater is considered as clinically relevant
    Chronic psychotraumatic impact of the visit on the child
    Scale of stress (Child IES-R : Impact of Event Scale- Revised) : score calculated on 40 points. A score of 17 or greater is considered as clinically relevant
    Psychological experience of the visit for the child
    semi directive interview
    Parental, family and caregiver support provided to the child during and following the visit
    semi directive interviews of caregiver/family
    Psychological experience of the visit according the child age
    semi directive interview analysed in subgroup: comparison between child aged from 6 to 10 years old versus 11 to 14 years old

    Secondary Outcome Measures

    Full Information

    First Posted
    April 9, 2019
    Last Updated
    May 16, 2019
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03954522
    Brief Title
    The Visiting Child and His Family in ICU
    Acronym
    ENVIFAR
    Official Title
    Evaluation in Children of the Psychological Impact of the Visit of a Hospitalized Relative in ICU
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2019 (Anticipated)
    Primary Completion Date
    August 1, 2020 (Anticipated)
    Study Completion Date
    February 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

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

    5. Study Description

    Brief Summary
    According to literature, it's difficult to evaluate the impact of the visit of the child in ICU. Currently, no recommendations are available regarding welcome and accompany children who visit their relative hospitalized in ICU. Collaboration between humanities and medical sciences brings to this question a complementary look. Majority of studies investigated the question of the impact of young child ICU visit in a unidirectional linear causality scheme visit = psychopathological impact. The visit of the child in ICU should not be considered as an isolated event whose objective characteristics would be alone vectors of trauma. Contrary, the child visit must be apprehended in relation to the quality of the supports on which the child can count. The investigators hypothesize that children can overcome the visit of a kin hospitalized in ICU if accompanying people can support the child and contain, before and after the visit, the emotions of the child.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intensive Care, Child, Acute Stress Disorder, Post Traumatic Stress Disorder
    Keywords
    ICU, acute stress, PTSD, child, parent hospitalized

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Expérimental
    Arm Type
    Experimental
    Arm Description
    psychologist interview and psychometrics scales
    Intervention Type
    Other
    Intervention Name(s)
    interview
    Intervention Description
    Child = A clinical interview (recorded, duration approximately 30 min) and a scale of acute stress (IES child) will be performed at 2 times (during the 7 days following the first visit of hospitalized kin and 1 month after the kin was discharged from ICU) Accompanying parent/kin = Semi-directive interviews (recorded - duration approximately 30 min) will be performed at the same time as those of the child and will be recorded. The parent/kin will also complete a socio-demographic questionnaire of the family group and a depression anxiety scale (HADS) Nursing staff = A semi-directive interview (recorded - duration approximately 30 min) will be performed only once (during the 7 days following the first visit to the hospitalized kin). The caregiver will also complete a socio-demographic questionnaire and a Moral Distress Scale (MDS-R) Hospitalized parent = One month after ICU discharge, a depression anxiety scale (HADS) and an acute stress scale (IES) will be performed
    Primary Outcome Measure Information:
    Title
    Acute psychotraumatic impact of the visit on the child
    Description
    Scale of stress (Child IES-R : Impact of Event Scale- Revised) : score calculated on 40 points. A score of 17 or greater is considered as clinically relevant
    Time Frame
    7 days
    Title
    Chronic psychotraumatic impact of the visit on the child
    Description
    Scale of stress (Child IES-R : Impact of Event Scale- Revised) : score calculated on 40 points. A score of 17 or greater is considered as clinically relevant
    Time Frame
    1 month
    Title
    Psychological experience of the visit for the child
    Description
    semi directive interview
    Time Frame
    7 days
    Title
    Parental, family and caregiver support provided to the child during and following the visit
    Description
    semi directive interviews of caregiver/family
    Time Frame
    1 month
    Title
    Psychological experience of the visit according the child age
    Description
    semi directive interview analysed in subgroup: comparison between child aged from 6 to 10 years old versus 11 to 14 years old
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: family groups in which at least one child aged 6 to 14 years having expressed the wish to visit his/her hospitalized relative family groups in which the non-hospitalized parent has expressed the wish to accompany his/her child during the visit parent hospitalized in ICU is at least 18 years old informed consent of children, non-hospitalized and/or hospitalized relatives informed consent of the accompanying caregiver Exclusion Criteria: moribund patient child unaccompanied by his/her parent/relative during the visit non-hospitalized non-French-speaking parent/relative (need to be able to answer the questionnaires) child benefiting from a psychological follow-up prior to the hospitalization of his/her parent non French-speaking child child under 6 years old or older than 14 hospitalized relative who died before the proposed interview with the child (particular attention will be carry out to the interview conditions. The loss of the hospitalized parent will not allow for an interview on the experience of the visit).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stéphanie NGUYEN
    Phone
    06.63.06.74.85
    Email
    stephanielaurent@gmx.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexandra LAURENT
    Email
    Alexandra.Laurent@u-bourgogne.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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