Post-traumatic Stress Disorder After Pediatric Intensive Care Unit Hospitalization
POETIC
1 other identifier
interventional
87
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2020
CompletedFirst Posted
Study publicly available on registry
December 1, 2020
CompletedStudy Start
First participant enrolled
January 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2021
CompletedNovember 15, 2022
November 1, 2022
1 month
November 23, 2020
November 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Between one and 6 months after hospitalization.
Study Arms (1)
Questionary
EXPERIMENTALQuestionary for all parents
Interventions
Parents of hospitalized children in pediatric resuscitation carry out a validated questionnaire that validates the post-traumatic stress level by a score.
Eligibility Criteria
You may qualify if:
- \- All parents of children aged 0 to 18 who have been admitted in paediatric resuscitation unit.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Toulouse
Toulouse, France
Study Officials
- PRINCIPAL INVESTIGATOR
Sophie BREINIG, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2020
First Posted
December 1, 2020
Study Start
January 26, 2021
Primary Completion
March 9, 2021
Study Completion
March 9, 2021
Last Updated
November 15, 2022
Record last verified: 2022-11