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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
Parents will be recruited in a Pediatric Resuscitation Department of the Mother and Child Hospital for 3 months. The doctor taking care of a child and his parents meeting the eligibility criteria will distribute, during the stay, a questionnaire accompanied by a pre-stamped envelope to the two parents not opposing the study. A phone call and / or an email reminder by the intern in the month of the exit will invite each parent to return the questionnaire. The completed questionnaire will be mailed back by the parents using the pre-stamped envelope.

Locations

Country Name City State
France Pediatric intensive care unit of Women-Mother-Children Hospital Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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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