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

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

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.

Study Overview

• Status: Unknown
• Conditions: Severe Trauma
• Intervention / Treatment: Behavioral: Questionnaire

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Philippe Meyer, MD; Phone Number: + 33 1 71 19 61 62; Email: philippe.meyer@aphp.fr
• Study Contact Backup: Name: Hélène Morel; Phone Number: + 33 1 71 19 63 46; Email: helene.morel@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Hopital Necker-Enfants Malades
    • Contact: Philippe Meyer, MD; Phone Number: + 33 1 71 19 61 62; Email: philippe.meyer@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Relatives of severe traumatized child; Relatives of a child who has been hospitalized in intensive care of Necker hospital following a severe trauma	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, post traumatic stress disorder, anxiety	Composite 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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio-demographic analysis	A 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)	18 months
Predictive factors for the occurrence of mental disorders	A 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.	18 months
Feeling of hospitalization	The 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:Visiting hours too restricted (Yes/No)Visits limited to parents (Yes/No)Insufficient availability of the medical team (Yes/No)Lack of availability of psychologists (Yes/No)Misunderstanding of the child's health problem (Yes/No); Follow-up by a psychologist (Yes/No)	18 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Philippe Meyer, Assistance Publique - Hôpitaux de Paris; Study Director: Florian Prevost, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Intensive care; Severe trauma; Post-traumatic stress
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: APHP190415; 2019-A01076-51 (Other Identifier: ID RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No