Clinical Trials Logo
  1. Home
  2. Parents
  3. NCT05892874
  4. Details
NCT05892874 Clinical Trial

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

Parents Clinical Trial

Official title:
Impact of Postoperative Medical Equipment Removal/Insertion on Parental Anxiety in Pediatric Cardiac Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05892874
Other study ID # PARANX
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 30, 2023
Est. completion date June 14, 2024

Study information
Verified date June 2024
Source Claude Bernard University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date June 14, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Unit 11 Hospices Civils of Lyon Bron Rhône-Alpes

Sponsors (2)
Lead Sponsor Collaborator
Claude Bernard University Research on Healthcare Performance Lab U1290

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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. at the arrival in the intensive care unit
See also
  Status Clinical Trial Phase
Completed NCT03679520 - New Programme for Antenatal Preparation for Early Parenthood N/A
Not yet recruiting NCT05806983 - Evaluation of the Efficiency of the Technology-Based Psychosocial Empowerment Program Program N/A
Completed NCT05413577 - Reducing Parental Stress Via Instant Messaging During COVID-19 Pandemic: A Randomized Controlled Trial N/A
Completed NCT04901611 - Parental Touch Trial (Petal) N/A
Completed NCT04342871 - An Evaluation of the Fathers and Mothers With Cancer Communication Tool N/A
Recruiting NCT02898285 - Promoting Sport Participation During Early Parenthood N/A
Completed NCT03007277 - Evaluation of the French Maternal and Child Protection Services From 11 French Territories That Have Received Common Intervention Guidelines N/A
Recruiting NCT05540041 - Reducing Anxiety of Children and Their Parents in the Pre-Operative Process With Therapeutic Play N/A
Recruiting NCT05997680 - A Parent-child Yoga Intervention for Reducing Attention Deficits in Children With Congenital Heart Disease: A Feasibility Study N/A
Not yet recruiting NCT05048277 - Single Session Consultation for Parents N/A
Completed NCT05656677 - Parental Involvement in Pain Reducing Measures N/A
Completed NCT03879642 - Reducing Hypoglycemia Fear in Parents of Young Children With Type 1 Diabetes N/A
Completed NCT04121897 - Therapist Education and Massage for Parent Infant-Outcomes N/A
Enrolling by invitation NCT05178290 - Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers N/A
Completed NCT02921958 - The Life Participation for Parents as an Outcome Measure
Completed NCT05019339 - HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity in SNAP-Education N/A
Completed NCT05463926 - Effect of 'Parentbot - a Digital Healthcare Assistant (PDA)' in Improving Parenting Outcomes During the Perinatal Period N/A
Recruiting NCT05919589 - Evaluating Care Integration for Children With Special Health Care Needs v1.0
Recruiting NCT04174404 - Intelligent Customer-driven Solution for Pediatric Surgery Care for Parents and Their Children Undergoing Circumcision N/A
Recruiting NCT05230199 - Sensory Optimization of the Hospital Environment N/A