Effect of Pediatric Intensive Care Unit (PICU) Diaries on the Post Intensive Care Syndrome (PICS-p) in Children and Young Adults and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Parent's Post Traumatic Stress Disease (PTSD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children/adolescents admitted to the PICU
- •Mechanical ventilation for > 48 hours
- •Patient's age <19 years old
排除标准
- •parents who are unable to communicate in Italian language
- •parents who have not signed and informed consent
- •patients with a poor prognosis
结局指标
主要结局
Parent's Post Traumatic Stress Disease (PTSD)
时间窗: 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.
Child's Anxiety
时间窗: 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.
Child's Depression
时间窗: Through study completion, an average of 3 year
The Patient Health Questionnaire-9 (PHQ-9) will be used to measure the child's depression.
Child's Post Traumatic Stress Disease (PTSD)
时间窗: 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)
Parent's Anxiety
时间窗: Through study completion, an average of 3 year
The Generalized Anxiety Disorder - 7 scale (GAD-7) will be used to measure parent's anxiety.
Child's Strengths and difficulties
时间窗: 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.
次要结局
- Patient's Quality of Life(Through study completion, an average of 3 year)
- Satisfaction with PICU care(Through study completion, an average of 3 year)
研究者
Orsola Gawronski
Principal Investigator
Bambino Gesù Children's Hospital IRCCS