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NCT05892874 Clinical Trial

Impact of Postoperative Medical Equipment Removal/Insertion on Parental Anxiety in Pediatric Cardiac Intensive Care Unit

Parents Clinical Trial

Official title:
Impact of Postoperative Medical Equipment Removal/Insertion on Parental Anxiety in Pediatric Cardiac Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05892874
Other study ID # PARANX
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2023
Est. completion date December 31, 2023

Study information
Verified date August 2023
Source Claude Bernard University
Contact Marc Lilot, PhD
Phone 0651806521
Email marc.lilot@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

A lot of observationnal studies describe parental stressors in PICU/PCICU, but none studied, prospectively, the links between medical equipment removal/insertion and anxiety modulation. The primary objective is to identify the impact of medical equipment removal/insertion on the STAI-Y score (anxiety) The secondary objective is to identify the parental anxiety determinant (via VAS).

Description:

A lot of observationnal studies describe parental stressors in Paediatric Intensive care Unit, but none studied, prospectively, the links between medical equipment removal or insertion and anxiety modulation. The primary objective is to identify the impact of medical equipment removal or insertion on the STAI-Y score (anxiety) The secondary objective is to identify the parental anxiety determinant (via Visual Analog Stress Scale. Parents will fill out questionnaire upon arrival in the Intensive care unit when reaching the bedside of their hospitalized child right after the elective cardiac surgery. Then after each equipment removal or insertion they will be asked to fill out again the same questionaire.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date December 31, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - parents/legal tutor of minor patient (congenital cardiopathy) with elective hospitalization in PCICU for surgical procedures Exclusion Criteria: - Parents no french speaking - child hospitalized for Cardiac Catheterization - child hospitalized for Berlin Heart insertion - child hospitalized for heart transplantation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Unit 11 Hospices Civils of Lyon Bron Rhône-Alpes

Sponsors (2)
Lead Sponsor Collaborator
Claude Bernard University Research on Healthcare Performance Lab U1290

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary State Trait Anxiety Index - Y version Anxiety declarative scale from 20 to 80 maximum and higher anxiety at the arrival in the intensive care unit
Secondary Visual Analogic Scale VAS from 0 to a maximum of 100 mm evaluating: their child confort ; the clinical information's clarity ; their possibility to participate to the care ; the impact on their parental role perceptions ; their trust in caregivers ; their satisfaction concernaing the caregivers attention ; their child clinical condition impacting their (and caregivers) presence in child hospitalization room. at the arrival in the intensive care unit
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