ENVIFAR: The Visiting Child and His Family in ICU

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Unknown status

CT.gov ID

NCT03954522

Collaborator

(none)

240

Enrollment

Arm

20.1

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intensive Care Child Acute Stress Disorder Post Traumatic Stress Disorder	Other: interview	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Evaluation in Children of the Psychological Impact of the Visit of a Hospitalized Relative in ICU

Anticipated Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Expérimental psychologist interview and psychometrics scales	Other: interview 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

Arm

Intervention/Treatment

Experimental: Expérimental

psychologist interview and psychometrics scales

Other: interview

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

Outcome Measures

Primary Outcome Measures

Acute psychotraumatic impact of the visit on the child [7 days]
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 [1 month]
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 [7 days]
semi directive interview
Parental, family and caregiver support provided to the child during and following the visit [1 month]
semi directive interviews of caregiver/family
Psychological experience of the visit according the child age [1 month]
semi directive interview analysed in subgroup: comparison between child aged from 6 to 10 years old versus 11 to 14 years old

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).