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Effect of Pediatric Intensive Care Unit Diaries on PICS-p

B

Bambino Gesù Children's Hospital IRCCS

Status

Enrolling

Conditions

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

Treatments

Other: PICU diary

Study type

Interventional

Funder types

Other

Identifiers

NCT06310109
2358_OPBG 2020

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

Under 19 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

110 participants in 2 patient groups

PICU diary
Experimental group
Description:
The "PICU diary" arm, will receive a PICU diary at the patient bedside.
Treatment:
Other: PICU diary
Control arm
No Intervention group
Description:
The control arm will receive standard care (no PICU diary).

Trial contacts and locations

1

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Central trial contact

Orsola Gawronski, PhD

Data sourced from clinicaltrials.gov

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