Back to resultsPost-traumatic Stress Disorder After Pediatric Intensive Care Unit Hospitalization (POETIC)
Primary Purpose
Post-traumatic Stress
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Post traumatic stress disorder questionnaire
Sponsored by
About this trial
This is an interventional other trial for Post-traumatic Stress
Eligibility 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
Sites / Locations
- CHU Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Questionary
Arm Description
Questionary for all parents
Outcomes
Primary Outcome Measures
Prevalence of post-traumatic stress disorder among parents of newborns, infants and children who have been hospitalized in a paediatric resuscitation unit.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04648605
First Posted
November 23, 2020
Last Updated
November 14, 2022
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT04648605
Brief Title
Post-traumatic Stress Disorder After Pediatric Intensive Care Unit Hospitalization
Acronym
POETIC
Official Title
Post-traumatic Stress Disorder Occurrence in Parents of Neonate and Children Hospitalized in an Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
March 9, 2021 (Actual)
Study Completion Date
March 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Questionary
Arm Type
Experimental
Arm Description
Questionary for all parents
Intervention Type
Other
Intervention Name(s)
Post traumatic stress disorder questionnaire
Intervention Description
Parents of hospitalized children in pediatric resuscitation carry out a validated questionnaire that validates the post-traumatic stress level by a score.
Primary Outcome Measure Information:
Title
Prevalence of post-traumatic stress disorder among parents of newborns, infants and children who have been hospitalized in a paediatric resuscitation unit.
Description
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.
Time Frame
Between one and 6 months after hospitalization.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie BREINIG, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
Country
France
12. IPD Sharing Statement
Learn more about this trial
Post-traumatic Stress Disorder After Pediatric Intensive Care Unit Hospitalization
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