Bambino Gesù Children's Hospital IRCCS
Rome, 00165, Italy
Location status: Recruiting
Location contact
Orsola Gawronski, PhD
CONTACT
NCT Number: NCT06310109
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.
Interested in participating?
Request InfoUp to 19 year
All sexes
Interventional
Not applicable
Rome, 00165, Italy
Location status: Recruiting
Orsola Gawronski, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
.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
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.
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.
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.
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)
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.
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.
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).
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).
Contact information is provided by the study sponsor or research team.
Bambino Gesù Children's Hospital IRCCS
Other
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
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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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