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CompletedNCT03954522ENVIFARUpdated Jan 16, 2025

The Visiting Child and His Family in ICU

An interventional study of interview in Intensive Care, Child and Acute Stress Disorder, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-16.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Not applicable
Ages
6 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Intensive Care
  • Child
  • Acute Stress Disorder
  • Post Traumatic Stress Disorder

Keywords

  • ICU
  • acute stress
  • PTSD
  • child
  • parent hospitalized
03

In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 57 is close to the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
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

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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Expérimental

    psychologist interview and psychometrics scales

    Other: interview

Interventions

  • Otherinterview

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 7 days

  2. 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

    Time frame: 1 month

  3. Psychological experience of the visit for the child

    semi directive interview

    Time frame: 7 days

  4. Parental, family and caregiver support provided to the child during and following the visit

    semi directive interviews of caregiver/family

    Time frame: 1 month

  5. 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

    Time frame: 1 month

07

Study locations

1 site
  • Chu de Besancon
    Besancon, 25000, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03954522
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
May 17, 2019
Start date
Sep 26, 2019
Primary completion
Nov 23, 2020
Completion
Dec 23, 2020
Last update
Jan 16, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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