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Post-traumatic Stress Disorder After Pediatric Intensive Care Unit Hospitalization (POETIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04648605
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief Summary:

The elements that promote the development of post-traumatic stress in parents following hospitalization in pediatric resuscitation and thus the options for improving initial care at the time of hospitalization are unknown.

It is therefore important to describe the prevalence of post-traumatic stress disorder with current pediatric resuscitation management data, but also to possibly describe the factors associated with it in order to optimize initial management.


Condition or disease Intervention/treatment Phase
Post-traumatic Stress Other: Post traumatic stress disorder questionnaire Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Post-traumatic Stress Disorder Occurrence in Parents of Neonate and Children Hospitalized in an Intensive Care Unit
Actual Study Start Date : January 26, 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Questionary
Questionary for all parents
 Other: Post traumatic stress disorder questionnaire
Parents of hospitalized children in pediatric resuscitation carry out a validated questionnaire that validates the post-traumatic stress level by a score.


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of post-traumatic stress disorder among parents of newborns, infants and children who have been hospitalized in a paediatric resuscitation unit. [ Time Frame: Between one and 6 months after hospitalization. ]
    Parents will complete Post-traumatic stress disorder Checklist. We will consider subjects with a score above 44 to be clinically affected by post-traumatic stress disorder.


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- All parents of children aged 0 to 18 who have been admitted in paediatric resuscitation unit.

Exclusion Criteria:

  • Holders of parental authority who cannot answer the questionnaire because they do not speak French.
  • Opposition of one of the two holders of parental authority
  • Minor parental authority holders
  • Holders of parental authority under safeguarding of justice or guardianship
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648605


Contacts
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Contact: Sophie BREINIG, MD 05.34.55.84.77 breinig.s@chu-toulouse.fr

Locations
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France
CHU Toulouse Recruiting
Toulouse, France
Contact: Sophie BREINIG, MD         
Principal Investigator: Sophie BREINIG         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Sophie BREINIG, MD CHU Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04648605    
Other Study ID Numbers: RC31/20/0406
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders