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

January 27, 2025 updated by: Lilot Marc, Claude Bernard University

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhône-Alpes
      • Bron, Rhône-Alpes, France, 69500
        • Unit 11 Hospices Civils of Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Parents of minor patients suffering from congenital cardiopathy, hospitalized for electuve surgical procedures

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Parents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the arrival in the intensive care unit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the arrival in the intensive care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Claude Bernard University

Collaborators

Research on Healthcare Performance Lab U1290

Investigators

  • Study Chair: Vincent Piriou, PhD, Hospices Civils of Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

June 14, 2024

Study Registration Dates

First Submitted

May 27, 2023

First Submitted That Met QC Criteria

May 27, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARANX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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