NCT05892874

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2024

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

May 27, 2023

Last Update Submit

January 27, 2025

Conditions

ParentsAnxiety Postoperative

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Visual Analogic Scale

    at the arrival in the intensive care unit

Study Arms (1)

Parents

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • parents/legal tutor of minor patient (congenital cardiopathy) with elective hospitalization in PCICU for surgical procedures

You may not qualify if:

  • Parents no french speaking
  • child hospitalized for Cardiac Catheterization
  • child hospitalized for Berlin Heart insertion
  • child hospitalized for heart transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit 11 Hospices Civils of Lyon

Bron, Auvergne-Rhône-Alpes, 69500, France

Location

Study Officials

  • Vincent Piriou, PhD

    Hospices Civils of Lyon

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of research

Study Record Dates

First Submitted

May 27, 2023

First Posted

June 7, 2023

Study Start

January 30, 2023

Primary Completion

May 30, 2024

Study Completion

June 14, 2024

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)