Post Intensive Care SyndromePICS-pNCT06310109
Effect of Pediatric Intensive Care Unit Diaries on PICS-p
A study testing PICU diary in people with Post Intensive Care Syndrome and Narrative Medicine, run by Bambino Gesù Children's Hospital IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Post Intensive Care Syndrome, Narrative Medicine, Post Traumatic Stress Disorder
- What is being tested?
- PICU diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jul 2021to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children/adolescents admitted to the PICU
- Mechanical ventilation for > 48 hours
- Patient's age <19 years old
Who cannot join
- parents who are unable to communicate in Italian language
- parents who have not signed and informed consent
- patients with a poor prognosis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Bambino Gesù Children's Hospital IRCCS
Rome, 00165
Orsola Gawronski, PhD
About this study
Official 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
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.
Read more
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.
- Conditions
- Post Intensive Care Syndrome, Narrative Medicine, Post Traumatic Stress Disorder, Anxiety, Depression
- Being tested
- PICU diary
- Keywords
- Post Intensive Care Syndrome, Pediatric, Children, Diary, ICU diary, Narrative medicine, Pediatric Intensive Care Unit
- Medical subject headings
- postintensive care syndrome, Narrative Medicine, Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICU diaryOther
Also called Journal
.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.
| Study group | Role | What they receive |
|---|---|---|
| PICU diary | Experimental | The "PICU diary" arm, will receive a PICU diary at the patient bedside. Receives: Other: PICU diary |
| Control arm | No intervention | The control arm will receive standard care (no PICU diary). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent's Post Traumatic Stress Disease (PTSD)
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.
Measured: Through study completion, an average of 3 year
Parent's Anxiety
The Generalized Anxiety Disorder - 7 scale (GAD-7) will be used to measure parent's anxiety.
Measured: Through study completion, an average of 3 year
Child's Strengths and difficulties
The Strengths and Difficulties Questionnaire (SDQ), a brief behavioural screening questionnaire about 2-17 year olds wukk be used.
Measured: Through study completion, an average of 3 year
Child's Post Traumatic Stress Disease (PTSD)
The child's PTSD will be measured using the Revised Child Impact of Event Scale - (R CRIES 8)
Measured: Through study completion, an average of 3 year
Child's Anxiety
The Generalized Anxiety Disorder - 7 scale (GAD-7) will be used to measure the child's anxiety disorder.
Measured: Through study completion, an average of 3 year
Child's Depression
The Patient Health Questionnaire-9 (PHQ-9) will be used to measure the child's depression.
Measured: Through study completion, an average of 3 year
Secondary outcomes (2)
Satisfaction with PICU care
Satisfaction with PICU care will be measured using The EMpowerment of PArents in The Intensive Care (EMPATHIC-P).
Measured: Through study completion, an average of 3 year
Patient's Quality of Life
The Quality of Life will be measured using the Pediatric Quality of Life Inventory (PedsQL).
Measured: Through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start14 Jul 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Principal investigator, Orsola Gawronski, Bambino Gesù Children's Hospital IRCCS
- Investigators
- Orsola Gawronski, PhD, Principal investigator, Bambino Gesù Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310109
- Sponsor's protocol ID
- 2358_OPBG 2020
- Acronym
- PICS-p
- Status last verified
- Aug 2024
- First submitted
- 6 Mar 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Limited dataset, pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06310109
- Acronym / sponsor ID
- PICS-p / 2358_OPBG 2020
- Conditions
- Post Intensive Care Syndrome, Narrative Medicine, Post Traumatic Stress Disorder, Anxiety, Depression
- Keywords
- Post Intensive Care Syndrome, Pediatric, Children, Diary, ICU diary, Narrative medicine, Pediatric Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Bambino Gesù Children's Hospital IRCCSUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICU diary | Experimental | Other: PICU diaryThe "PICU diary" arm, will receive a PICU diary at the patient bedside. |
| Control arm | No intervention | –The control arm will receive standard care (no PICU diary). |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- children/adolescents admitted to the PICU
- Mechanical ventilation for > 48 hours
- Patient's age <19 years old
Key exclusion criteria (3 listed)
- parents who are unable to communicate in Italian language
- parents who have not signed and informed consent
- patients with a poor prognosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICU diaryAlso: Journal.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 | PICU diary |
Primary outcome
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.
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.
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.
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)
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.
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.
2 secondary outcomes
Satisfaction with PICU care
Time frame: Through study completion, an average of 3 year
Patient's Quality of Life
Time frame: Through study completion, an average of 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No. Limited dataset, pilot study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orsola Gawronski, PhD principal investigator
Bambino Gesù Children's Hospital IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICU diary in people with Post Intensive Care Syndrome and Narrative Medicine, run by Bambino Gesù Children's Hospital IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orsola Gawronski, PhD (+393286011479, orsola.gawronski@opbg.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent's Post Traumatic Stress Disease (PTSD) (time frame: Through study completion, an average of 3 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.