Impact of Postoperative Medical Equipment Removal/inserti... | NCT05892874

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

NCT05892874

Sponsor

Claude Bernard University

Status

Completed

Last Update Posted

Jan 28, 2025Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Parents
Anxiety Postoperative

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2023Actual

Primary Completion Date

May 30, 2024Actual

Completion Date

Jun 14, 2024Actual

First Submitted Date

May 27, 2023

First Submission Date that Met QC Criteria

May 27, 2023

First Posted Date

Jun 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2025

Last Update Posted Date

Jan 28, 2025Actual

Name	Class
Research on Healthcare Performance Lab U1290	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Label	Type	Description	Intervention Names
Parents

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent Piriou, PhD	Hospices Civils of Lyon	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unit 11 Hospices Civils of Lyon		Bron	Auvergne-Rhône-Alpes	69500	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided