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

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).

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Key information

Conditions

Parents Anxiety Postoperative

Sex eligibility

All sexes

Study type

Observational

Primary location

Unit 11 Hospices Civils of Lyon

Bron, Auvergne-Rhône-Alpes, 69500, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

State Trait Anxiety Index - Y version

Time frame: at the arrival in the intensive care unit

Anxiety declarative scale from 20 to 80 maximum and higher anxiety

Secondary outcomes

Visual Analogic Scale

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Collaborators

Research on Healthcare Performance Lab U1290

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jun 7, 2023
Registry last updated: Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed