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

NCT ID: NCT04168827

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2021-06-09

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.

Conditions

Severe Trauma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Relatives of severe traumatized child

Relatives of a child who has been hospitalized in intensive care of Necker hospital following a severe trauma

Questionnaire

Intervention Type: BEHAVIORAL

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

Interventions

Questionnaire

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Meyer

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Florian Prevost

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Necker-Enfants Malades

Paris, , France

Countries

France

Other Identifiers

2019-A01076-51

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190415

Identifier Type: -

Identifier Source: org_study_id