Effect of Pediatric Intensive Care Unit Diaries on PICS-p

Depression Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06310109
• Other study ID #: 2358_OPBG 2020
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: March 2024
• Source: Bambino Gesù Children's Hospital IRCCS
• Contact: Orsola Gawronski, PhD
• Phone: +393286011479
• Email: orsola.gawronski[@]opbg.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: October 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Italy	Bambino Gesù Children's Hospital IRCCS	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Bambino Gesù Children's Hospital IRCCS	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent's Post Traumatic Stress Disease (PTSD)	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.	Through study completion, an average of 3 year
Primary	Parent's Anxiety	The Generalized Anxiety Disorder - 7 scale (GAD-7) will be used to measure parent's anxiety.	Through study completion, an average of 3 year
Primary	Child's Strengths and difficulties	The Strengths and Difficulties Questionnaire (SDQ), a brief behavioural screening questionnaire about 2-17 year olds wukk be used.	Through study completion, an average of 3 year
Primary	Child's Post Traumatic Stress Disease (PTSD)	The child's PTSD will be measured using the Revised Child Impact of Event Scale - (R CRIES 8)	Through study completion, an average of 3 year
Primary	Child's Anxiety	The Generalized Anxiety Disorder - 7 scale (GAD-7) will be used to measure the child's anxiety disorder.	Through study completion, an average of 3 year
Primary	Child's Depression	The Patient Health Questionnaire-9 (PHQ-9) will be used to measure the child's depression.	Through study completion, an average of 3 year
Secondary	Satisfaction with PICU care	Satisfaction with PICU care will be measured using The EMpowerment of PArents in The Intensive Care (EMPATHIC-P).	Through study completion, an average of 3 year
Secondary	Patient's Quality of Life	The Quality of Life will be measured using the Pediatric Quality of Life Inventory (PedsQL).	Through study completion, an average of 3 year