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

Completed

• Conditions: Parents; Anxiety Postoperative

• Registration Number: NCT05892874
• Lead Sponsor: Claude Bernard University

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2023-01-30
• Study First Submitted: 2023-05-27
• Study First Submitted QC: 2023-05-27
• Study First Posted: 2023-06-07
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
State Trait Anxiety Index - Y version	at the arrival in the intensive care unit	Anxiety declarative scale from 20 to 80 maximum and higher anxiety

Secondary Outcome Measures

Name	Time	Method
Visual Analogic Scale	at the arrival in the intensive care unit	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.

Trial Locations

Locations (1)

Unit 11 Hospices Civils of Lyon; 🇫🇷 Bron, Rhône-Alpes, France