- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03828552
Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit. (VECUREA)
Children recovered in pediatric intensive care unit (PICU) suffer from severe conditions, sometimes life-threatening. Thus, priority is given to urgent somatic care, children medicalization is strong, invasive technics have to be used, and medical monitoring is close.
A stay in PICU often leaves a painful memory to the child and family, and can lead to psychological morbidity such as post-traumatic stress disease.
This study aims to assess parents' experience during their child hospitalization in PICU, and the impact of this stay on the entire family in the following month.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bron, France, 69677
- Pediatric intensive care unit of Women-Mother-Children Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Parent (mother or /and father) of a recovered child in PICU.
- No limit of age, disease or admission mode.
- First stay in PICU, for at least a 3 days stay.
- Parents having been informed and having accepted the participation in the study.
Exclusion Criteria:
- Death of the child during the stay in PICU or during the month following the discharge from PICU
- Non-fluent french speakers/readers.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analyse qualitatively the parents'experience during the PICU stay of their child
Time Frame: 1 month
|
Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale)
|
1 month
|
|
Assessment of the impact on the family of this PICU stay of their child
Time Frame: 1 month
|
Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale)
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 69HCL18_0700
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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