Skip to main content
Clinical Trials/NCT06310109
NCT06310109
Recruiting
Not Applicable

Effect of Pediatric Intensive Care Unit (PICU) Diaries on the Post Intensive Care Syndrome (PICS-p) in Children and Young Adults and Their Caregivers

Bambino Gesù Children's Hospital IRCCS1 site in 1 country110 target enrollmentJuly 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Intensive Care Syndrome
Sponsor
Bambino Gesù Children's Hospital IRCCS
Enrollment
110
Locations
1
Primary Endpoint
Parent's Post Traumatic Stress Disease (PTSD)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

When children become very sick and need to stay in a Pediatric Intensive Care Unit (PICU), it can have a big impact on their recovery and their family's well-being. Sometimes kids and their families feel worried or sad even after they leave the hospital. This can have an impact on the quality of their life after hospital discharge.

To help understand and improve these experiences, the investigators want to study the "PICU diaries." These are journals that families and hospital staff can write in during the child's time in the hospital. Parents, other visitors and healthcare professionals can share thoughts, experiences, and even drawings or photos related to the child's admission. The content is a narrative account of what happens during the child's hospital stay, for the family to take home at PICU discharge.

The investigators believe that writing in these diaries might help children and their families feel better after leaving the hospital. It might help kids feel less worried or sad, and it might also help their parents or caregivers feel better too.

The study will include children who have been in the PICU and their families. Some families will receive these special diaries to use during their time in the hospital, while others won't. We'll then see how everyone feels after they leave the hospital and compare the two groups to see if the diaries make a difference.

The investigators hope that by understanding how these diaries can help, healthcare professionals can make hospital experiences better for everyone involved.

Registry
clinicaltrials.gov
Start Date
July 14, 2021
End Date
October 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bambino Gesù Children's Hospital IRCCS
Responsible Party
Principal Investigator
Principal Investigator

Orsola Gawronski

Principal Investigator

Bambino Gesù Children's Hospital IRCCS

Eligibility Criteria

Inclusion Criteria

  • children/adolescents admitted to the PICU
  • Mechanical ventilation for \> 48 hours
  • Patient's age \<19 years old

Exclusion Criteria

  • parents who are unable to communicate in Italian language
  • parents who have not signed and informed consent
  • patients with a poor prognosis

Outcomes

Primary Outcomes

Parent's Post Traumatic Stress Disease (PTSD)

Time Frame: Through study completion, an average of 3 year

The PTSD Checklist according to the Diagnostic and Statistical Manual of Mental Disorders (PCL-5) will be used to measure parent's post traumatic stress after PICU discharge.

Child's Anxiety

Time Frame: Through study completion, an average of 3 year

The Generalized Anxiety Disorder - 7 scale (GAD-7) will be used to measure the child's anxiety disorder.

Child's Depression

Time Frame: Through study completion, an average of 3 year

The Patient Health Questionnaire-9 (PHQ-9) will be used to measure the child's depression.

Child's Post Traumatic Stress Disease (PTSD)

Time Frame: Through study completion, an average of 3 year

The child's PTSD will be measured using the Revised Child Impact of Event Scale - (R CRIES 8)

Parent's Anxiety

Time Frame: Through study completion, an average of 3 year

The Generalized Anxiety Disorder - 7 scale (GAD-7) will be used to measure parent's anxiety.

Child's Strengths and difficulties

Time Frame: Through study completion, an average of 3 year

The Strengths and Difficulties Questionnaire (SDQ), a brief behavioural screening questionnaire about 2-17 year olds wukk be used.

Secondary Outcomes

  • Patient's Quality of Life(Through study completion, an average of 3 year)
  • Satisfaction with PICU care(Through study completion, an average of 3 year)

Study Sites (1)

Loading locations...

Similar Trials