The Visiting Child and His Family in ICU

NCT03954522 | Completed DMC

• 1 other identifier: P/2018/354
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ICU; acute stress; PTSD; child; parent hospitalized

Outcome Measures

Primary Outcomes (5)

• 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

  7 days

• 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

  1 month

• Psychological experience of the visit for the child

  semi directive interview

  7 days

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

  semi directive interviews of caregiver/family

  1 month

• 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

  1 month

Study Arms (1)

Expérimental

EXPERIMENTAL

psychologist interview and psychometrics scales

Other: interview

Interventions

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

Expérimental

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Chu de Besancon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Stress Disorders, Traumatic, Acute; Stress Disorders, Post-Traumatic

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: May 17, 2019
• Study Start: September 26, 2019
• Primary Completion: November 23, 2020
• Study Completion: December 23, 2020
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

FR (1)