protocolSection identificationModule nctId: NCT06310109, orgStudyIdInfo id: 2358_OPBG 2020, briefTitle: Effect of Pediatric Intensive Care Unit Diaries on PICS-p, acronym: PICS-p, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-14, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Bambino Gesù Children's Hospital IRCCS, class: OTHER, collaborators name: Ministry of Health, Italy, descriptionModule briefSummary: 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., conditionsModule conditions: Post Intensive Care Syndrome, conditions: Narrative Medicine, conditions: Post Traumatic Stress Disorder, conditions: Anxiety, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: PICU diary, outcomesModule primaryOutcomes measure: Parent's Post Traumatic Stress Disease (PTSD), primaryOutcomes measure: Parent's Anxiety, primaryOutcomes measure: Child's Strengths and difficulties, primaryOutcomes measure: Child's Post Traumatic Stress Disease (PTSD), primaryOutcomes measure: Child's Anxiety, primaryOutcomes measure: Child's Depression, secondaryOutcomes measure: Satisfaction with PICU care, secondaryOutcomes measure: Patient's Quality of Life, eligibilityModule sex: ALL, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Bambino Gesù Children's Hospital IRCCS, status: RECRUITING, city: Rome, zip: 00165, country: Italy, contacts name: Orsola Gawronski, PhD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False