Intensive Care Unit Syndrome Clinical Trial
— VECUREAOfficial title:
Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.
| NCT number | NCT03828552 |
| Other study ID # | 69HCL18_0700 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 4, 2019 |
| Est. completion date | June 21, 2019 |
| Verified date | September 2019 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 47 |
| Est. completion date | June 21, 2019 |
| Est. primary completion date | June 21, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Pediatric intensive care unit of Women-Mother-Children Hospital | Bron |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Analyse qualitatively the parents'experience during the PICU stay of their child | Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale) | 1 month | |
| Primary | Assessment of the impact on the family of this PICU stay of their child | Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale) | 1 month |
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