Effect of Pediatric Intensive Care Unit Diaries on PICS-p

NCT06310109 | Recruiting

• 1 other identifier: 2358_OPBG 2020
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Satisfaction with PICU care

  Through study completion, an average of 3 year

• Patient's Quality of Life

  Through study completion, an average of 3 year

Study Arms (2)

PICU diary

EXPERIMENTAL

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

Other: PICU diary

Control arm

NO INTERVENTION

The control arm will receive standard care (no PICU diary).

Interventions

PICU diary OTHER

.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.

Also known as: Journal

PICU diary

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children/adolescents admitted to the PICU
• Mechanical ventilation for \> 48 hours
• Patient's age \<19 years old

You may not qualify if:

• parents who are unable to communicate in Italian language
• parents who have not signed and informed consent
• patients with a poor prognosis

Sponsors & Collaborators

• Bambino Gesù Children's Hospital IRCCS: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

Bambino Gesù Children's Hospital IRCCS

Rome, 00165, Italy

RECRUITING

MeSH Terms

Conditions

postintensive care syndrome; Narrative Medicine; Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Narration; Communication; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms

Study Officials

• Orsola Gawronski, PhD

  Bambino Gesù Children's Hospital IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Orsola Gawronski, PhD

CONTACT

+393286011479; orsola.gawronski@opbg.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 15, 2024
• Study Start: July 14, 2021
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)