Effect of Pediatric Intensive Care Unit Diaries on PICS-p
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PICU diary.
- Who it may be relevant to
- Registry conditions: Post Intensive Care Syndrome, Narrative Medicine, Post Traumatic Stress Disorder, Anxiety. Basic parameters: up to 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other PICU diary
.The PICU diary is a notebook with lined sheets located at the patient's bedside. In this diary parents, other caregivers, family members, healthcare professionals or other visitors can write thoughts, report events related to the child/adolescent's admission, attach drawings or photographs for the patient or related to the PICU admission.
Primary outcome measures
- Parent's Post Traumatic Stress Disease (PTSD) [Time frame: Through study completion, an average of 3 year]
- Parent's Anxiety [Time frame: Through study completion, an average of 3 year]
- Child's Strengths and difficulties [Time frame: Through study completion, an average of 3 year]
- Child's Post Traumatic Stress Disease (PTSD) [Time frame: Through study completion, an average of 3 year]
- Child's Anxiety [Time frame: Through study completion, an average of 3 year]
- Child's Depression [Time frame: Through study completion, an average of 3 year]
Secondary outcome measures (2)
- Satisfaction with PICU care [Time frame: Through study completion, an average of 3 year]
- Patient's Quality of Life [Time frame: Through study completion, an average of 3 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Italy · 1 center
- Bambino Gesù Children's Hospital IRCCS — Rome
Identifiers
NCT: NCT06310109 · 2358_OPBG 2020