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The Visiting Child and His Family in ICU (ENVIFAR)

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ClinicalTrials.gov Identifier: NCT03954522
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : February 1, 2021

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





Primary Outcome Measures :
  1. Acute psychotraumatic impact of the visit on the child [ Time Frame: 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


  2. Chronic psychotraumatic impact of the visit on the child [ Time Frame: 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


  3. Psychological experience of the visit for the child [ Time Frame: 7 days ]
    semi directive interview

  4. Parental, family and caregiver support provided to the child during and following the visit [ Time Frame: 1 month ]
    semi directive interviews of caregiver/family

  5. Psychological experience of the visit according the child age [ Time Frame: 1 month ]
    semi directive interview analysed in subgroup: comparison between child aged from 6 to 10 years old versus 11 to 14 years old



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954522


Contacts
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Contact: Stéphanie NGUYEN 06.63.06.74.85 stephanielaurent@gmx.fr
Contact: Alexandra LAURENT Alexandra.Laurent@u-bourgogne.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03954522     History of Changes
Other Study ID Numbers: P/2018/354
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
ICU
acute stress
PTSD
child
parent hospitalized

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic, Acute
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders