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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01076-51 | Other Identifier | ID RCB number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relatives of severe traumatized child | Relatives of a child who has been hospitalized in intensive care of Necker hospital following a severe trauma |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | 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 |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Socio-demographic analysis | A socio-demographic analysis of the population with data collected by a questionnaire focusing on :
|
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Meyer | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Florian Prevost | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker-Enfants Malades | Paris | 75015 | France |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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 :
| 18 months |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |