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Completed

NCT Number: NCT03954522

The Visiting Child and His Family in ICU

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.

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Key information

Conditions

Intensive Care Acute Stress Disorder Child Mental Disorders Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Stress Disorders, Traumatic, Acute Trauma and Stressor Related Disorders

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Besancon

Besançon, 25000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

interview

Other

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: ENVIFAR

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 17, 2019
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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