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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT04648605
Collaborator
(none)
400
Enrollment
1
Location
1
Arm
4.1
Anticipated Duration (Months)
96.6
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Post traumatic stress disorder questionnaire
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 26, 2021
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

ArmIntervention/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

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. [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

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1CHU ToulouseToulouseFrance

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Sophie BREINIG, MD, CHU Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT04648605
Other Study ID Numbers:
  • RC31/20/0406
First Posted:
Dec 1, 2020
Last Update Posted:
Mar 15, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2021