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
About this trial
This is an interventional other trial for Intensive Care focused on measuring ICU, acute stress, PTSD, child, parent hospitalized
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).
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
NCT ID
NCT03954522
First Posted
April 9, 2019
Last Updated
May 16, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
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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