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Effect of Pediatric Intensive Care Unit Diaries on PICS-p

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06310109
Acronym
PICS-p
Enrollment
110
Registered
2024-03-15
Start date
2021-07-14
Completion date
2024-10-31
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Narrative Medicine, Post Intensive Care Syndrome, Post Traumatic Stress Disorder

Keywords

Post Intensive Care Syndrome, Pediatric, Children, Diary, ICU diary, Narrative medicine, Pediatric Intensive Care Unit

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.

Interventions

OTHERPICU 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.

Sponsors

Ministry of Health, Italy
CollaboratorOTHER_GOV
Bambino Gesù Children's Hospital IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 19 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Child's DepressionThrough study completion, an average of 3 yearThe Patient Health Questionnaire-9 (PHQ-9) will be used to measure the child's depression.
Child's Post Traumatic Stress Disease (PTSD)Through study completion, an average of 3 yearThe child's PTSD will be measured using the Revised Child Impact of Event Scale - (R CRIES 8)
Child's AnxietyThrough study completion, an average of 3 yearThe Generalized Anxiety Disorder - 7 scale (GAD-7) will be used to measure the child's anxiety disorder.
Parent's Post Traumatic Stress Disease (PTSD)Through study completion, an average of 3 yearThe 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.
Parent's AnxietyThrough study completion, an average of 3 yearThe Generalized Anxiety Disorder - 7 scale (GAD-7) will be used to measure parent's anxiety.
Child's Strengths and difficultiesThrough study completion, an average of 3 yearThe Strengths and Difficulties Questionnaire (SDQ), a brief behavioural screening questionnaire about 2-17 year olds wukk be used.

Secondary

MeasureTime frameDescription
Patient's Quality of LifeThrough study completion, an average of 3 yearThe Quality of Life will be measured using the Pediatric Quality of Life Inventory (PedsQL).
Satisfaction with PICU careThrough study completion, an average of 3 yearSatisfaction with PICU care will be measured using The EMpowerment of PArents in The Intensive Care (EMPATHIC-P).

Countries

Italy

Contacts

Primary ContactOrsola Gawronski, PhD
orsola.gawronski@opbg.net+393286011479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026