Skip to content

Emotional and Social Impact on the Relatives of Hospitalized Children for Severe Trauma

Emotional and Social Impact on the Relatives of Hospitalized Children for Severe Trauma of 3 to 6 Months After the Intensive Care Unit Leaving

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04168827
Acronym
RESPET
Enrollment
62
Registered
2019-11-19
Start date
2019-12-09
Completion date
2021-06-09
Last updated
2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Trauma

Keywords

Severe trauma, Post-traumatic stress, Anxiety, Depression, Intensive care

Brief summary

This research aims to study the occurrence of post-traumatic stress, anxiety or depression in the parents of a child who has been hospitalized in intensive care unit following a severe trauma.

Detailed description

With nearly 25% of trauma deaths, trauma is one of the leading causes of death in the world for children aged 5 to 14 years. In children under 4, it is responsible for 6% of deaths. Severe trauma is defined by an Abbreviated Injury Scale \> 3 score in at least one anatomical region. In case of multiple traumas, the Injury Severity Score is used to define severe polytrauma if it is \> 15. Cranial trauma is the most common lesion found in polytraumatized children and is present in 80% of cases. Serious head trauma is defined as the existence of a cranial trauma in a patient whose Glasgow score is less than or equal to 8. Severe trauma is a source of high mortality and severe disability in surviving children. Due to the context of sudden onset, a prolonged length of hospitalization in intensive care, as well as the occurrence of often severe sequelae, the severe trauma causes a real upheaval for the child's relatives. In adults, the occurrence of post-traumatic stress, anxiety and depression is relatively well described in patients and relatives of patients who have been hospitalized in intensive care unit. However, there is currently no pediatric study focusing on this subject, apart from neonatology where the traumatological context remains exceptional. This research aims to study the occurrence of post-traumatic stress, anxiety or depression in the parents of a child who has been hospitalized in intensive care unit following a severe trauma.

Interventions

BEHAVIORALQuestionnaire

Questionnaire completed by the parents of severe traumatized child, between 3 to 6 months after the leaving of the child out of intensive care unit

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Holder of the parental authority of a patient under 18 who has been hospitalized in the surgical intensive care unit of Necker University Hospital for severe trauma (Abbreviated Injury Scale greater than or equal to 3 in one of the anatomical regions) at the admission in the service and regardless of the ending of hospitalization. * Holder of parental authority over 18 years. * Holder of parental authority speaking French.

Exclusion criteria

* Holder of parental authority refusing to participate in the study, after submission of the information document. * Holder of parental authority unable to answer the questionnaire.

Design outcomes

Primary

MeasureTime frameDescription
Depression, post traumatic stress disorder, anxiety18 monthsComposite criterion considered positive if : The subject obtains a score greater than or equal to 13 in the Hospital Anxiety and Depression Scale questionnaire, thus defining a state of anxiety and depression. Hospital Anxiety and Depression Scale score range from 0 to 42 with higher scores indicating worse symptoms. and / or The subject obtains a score greater than or equal to 8 on one of the of the Hospital Anxiety and Depression Scale score. The Hospital Anxiety and Depression Scale score is separated in two section, one for Anxiety and one for depression. Each subscales range from 0 to 21 with higher scores indicating worse symptoms. and / or The subject obtains a score greater than or equal to 30 in the Impact of Event Scale Revised questionnaire defining high risk of presence of a post-traumatic stress disorder. The Impact of Event Scale Revised scores range from 0 to 88, with higher scores indicating worse symptoms.

Secondary

MeasureTime frameDescription
Socio-demographic analysis18 monthsA socio-demographic analysis of the population with data collected by a questionnaire focusing on : * Parent's age (in years) * The presence of a chronic disease (Yes/No) * The presence of psychiatric follow-up (Yes/No) * Taking antidepressant, neuroleptic or anxiolytic drugs (Yes/No) * Modification of marital status (Yes/No) * The presence of difficulties in the relationship with the spouse (Yes/No) * The evolution of professional status (No change / Loss of employment / Sickness leave / Decrease in professional activity) * The presence of financial difficulties (Yes/No)
Predictive factors for the occurrence of mental disorders18 monthsA search for predictive factors of the occurrence of a mental disorder will be conducted using the questionnaire and medical data from the child's file. Sub-group analyses will be carried out according to the results.
Feeling of hospitalization18 monthsThe experience of relatives of hospitalization will be studied on the basis of the questionnaire focusing on : * Sufficient medical information by the team (Yes/No) * Suffering from the following situation: 1. Visiting hours too restricted (Yes/No) 2. Visits limited to parents (Yes/No) 3. Insufficient availability of the medical team (Yes/No) 4. Lack of availability of psychologists (Yes/No) 5. Misunderstanding of the child's health problem (Yes/No) * Follow-up by a psychologist (Yes/No)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPhilippe Meyer

Assistance Publique - Hôpitaux de Paris

STUDY_DIRECTORFlorian Prevost

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026