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NCT Number: NCT04168827

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

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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Key information

Conditions

Severe Trauma Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Depression, post traumatic stress disorder, anxiety

    Time frame: 18 months

    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.

Secondary outcomes

  1. Socio-demographic analysis

    Time frame: 18 months

    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)

  2. Predictive factors for the occurrence of mental disorders

    Time frame: 18 months

    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.

  3. Feeling of hospitalization

    Time frame: 18 months

    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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: RESPET

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2019
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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