Clinical trial NCT06310109: Effect of Pediatric Intensive Care Unit Diaries on PICS-p
Official title: Effect of Pediatric Intensive Care Unit (PICU) Diaries on the Post Intensive Care Syndrome (PICS-p) in Children and Young Adults and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Intensive Care Syndrome
Narrative Medicine
Post Traumatic Stress Disorder
Anxiety
Depression
Keywords: Post Intensive Care Syndrome
Pediatric
Children
Diary
ICU diary
Narrative medicine
Pediatric Intensive Care Unit
Lead sponsor: Bambino Gesù Children's Hospital IRCCS
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2024-03-15
Enrollment: 110
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Parent's Post Traumatic Stress Disease (PTSD)
timeFrame: Through study completion, an average of 3 year
measure: Parent's Anxiety
timeFrame: Through study completion, an average of 3 year
measure: Child's Strengths and difficulties
timeFrame: Through study completion, an average of 3 year
measure: Child's Post Traumatic Stress Disease (PTSD)
timeFrame: Through study completion, an average of 3 year
measure: Child's Anxiety
timeFrame: Through study completion, an average of 3 year
measure: Child's Depression
timeFrame: Through study completion, an average of 3 year
Secondary outcomes:
measure: Satisfaction with PICU care
timeFrame: Through study completion, an average of 3 year
measure: Patient's Quality of Life
timeFrame: Through study completion, an average of 3 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Children's Hospital IRCCS
Study officials:
affiliation: Bambino Gesù Children's Hospital IRCCS
name: Orsola Gawronski, PhD
role: PRINCIPAL_INVESTIGATOR
References: