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

NCT ID: NCT05892874

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-30

Study Completion Date

2024-06-14

Brief Summary

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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

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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.

Conditions

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Parents Anxiety Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Parents

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research on Healthcare Performance Lab U1290

OTHER

Sponsor Role collaborator

Claude Bernard University

OTHER

Sponsor Role lead

Responsible Party

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Lilot Marc

Director of research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincent Piriou, PhD

Role: STUDY_CHAIR

Hospices Civils of Lyon

Locations

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Unit 11 Hospices Civils of Lyon

Bron, Auvergne-Rhône-Alpes, France

Site Status

Countries

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France

Other Identifiers

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PARANX

Identifier Type: -

Identifier Source: org_study_id

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