Effect of Pediatric Intensive Care Unit Diaries on PICS-p (PICS-p)

August 7, 2024 updated by: Orsola Gawronski, Bambino Gesù Children's Hospital IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Rome, Italy, 00165
        • Recruiting
        • Bambino Gesù Children's Hospital IRCCS
        • Contact:
          • Orsola Gawronski, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PICU diary
The "PICU diary" arm, will receive a PICU diary at the patient bedside.
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.
Other Names:
  • Journal
No Intervention: Control arm
The control arm will receive standard care (no PICU diary).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent's Post Traumatic Stress Disease (PTSD)
Time Frame: 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.
Through study completion, an average of 3 year
Parent's Anxiety
Time Frame: Through study completion, an average of 3 year
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
Time Frame: 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.
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
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
Time Frame: 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.
Through study completion, an average of 3 year
Child's Depression
Time Frame: Through study completion, an average of 3 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with PICU care
Time Frame: 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).
Through study completion, an average of 3 year
Patient's Quality of Life
Time Frame: Through study completion, an average of 3 year
The Quality of Life will be measured using the Pediatric Quality of Life Inventory (PedsQL).
Through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bambino Gesù Children's Hospital IRCCS

Collaborators

Ministry of Health, Italy

Investigators

  • Principal Investigator: Orsola Gawronski, PhD, Bambino Gesù Children's Hospital IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2021

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2358_OPBG 2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Limited dataset, pilot study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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