Effect of Pediatric Intensive Care Unit Diaries on PICS-p

Not Applicable

Recruiting

• Conditions: Post Traumatic Stress Disorder; Narrative Medicine; Anxiety; Post Intensive Care Syndrome; Depression
• Interventions: Other: PICU diary

• Registration Number: NCT06310109
• Lead Sponsor: Bambino Gesù Children's Hospital IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-14
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PICU diary	PICU diary	The "PICU diary" arm, will receive a PICU diary at the patient bedside.

Primary Outcome Measures

Name	Time	Method
Parent's Post Traumatic Stress Disease (PTSD)	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	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	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)	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	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	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 Outcome Measures

Name	Time	Method
Patient's Quality of Life	Through study completion, an average of 3 year	The Quality of Life will be measured using the Pediatric Quality of Life Inventory (PedsQL).
Satisfaction with PICU care	Through study completion, an average of 3 year	Satisfaction with PICU care will be measured using The EMpowerment of PArents in The Intensive Care (EMPATHIC-P).

Trial Locations

Locations (1)

Bambino Gesù Children's Hospital IRCCS; 🇮🇹 Rome, Italy