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NCT Number: NCT06310109

Effect of Pediatric Intensive Care Unit Diaries on PICS-p

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.

Recruiting

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Key information

Age range

Up to 19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bambino Gesù Children's Hospital IRCCS

Rome, 00165, Italy

Location status: Recruiting

Location contact

Orsola Gawronski, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Journal

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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.

  6. 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.

Secondary outcomes

  1. 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).

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Orsola Gawronski, PhD

CONTACT

[email protected]

+393286011479

Sponsors and collaborators

Lead sponsor

Bambino Gesù Children's Hospital IRCCS

Other

Collaborators

  • Ministry of Health, Italy

Registry information

Official study 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

Acronym: PICS-p

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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