Effect of Pediatric Intensive Care Unit Diaries on PICS-p

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Parent's Post Traumatic Stress Disease (PTSD) [Срок оценки: Through study completion, an average of 3 year]
• Parent's Anxiety [Срок оценки: Through study completion, an average of 3 year]
• Child's Strengths and difficulties [Срок оценки: Through study completion, an average of 3 year]
• Child's Post Traumatic Stress Disease (PTSD) [Срок оценки: Through study completion, an average of 3 year]
• Child's Anxiety [Срок оценки: Through study completion, an average of 3 year]
• Child's Depression [Срок оценки: Through study completion, an average of 3 year]

Вторичные конечные точки (2)

• Satisfaction with PICU care [Срок оценки: Through study completion, an average of 3 year]
• Patient's Quality of Life [Срок оценки: Through study completion, an average of 3 year]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Италия · 1 центр

• Bambino Gesù Children's Hospital IRCCS — Rome

Идентификаторы

NCT: NCT06310109 · 2358_OPBG 2020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗