Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697173
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2021-01-04
Brief Title:
Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to find out about how obtaining consent for procedures in the PICU affects parentalcaregiver stress The researchers think that alleviating some of the uncertainly of a PICU stay by discussing types of procedural support offered and obtaining informed consent prior to their immediate necessity may help decrease stress experienced by caregivers This study will allow the researchers to learn more about it
Detailed Description:
Having a child admitted to the Pediatric Intensive Care Unit PICU is a deeply challenging and stressful experience for parents and caregivers Despite the high survival when compared to adult ICUs a PICU admission can have meaningful long-term negative health consequences for adult caregivers including symptoms of depression anxiety and PTSD There is little known in regards to what specific factors impact the mental health of parentscaregivers of PICU patients However research into stress and anxiety has suggested that uncertainty is a significant contributor to stress when faced with a new environment
Usual informed consent for procedures performed in the PICU is obtained immediately prior to the procedure Participants will be randomly assigned like the flip of a coin to either usual informed consent prior to each procedure or to a single consent form obtained upon admission to PICU for possible procedures their child may undergo In this study participants will be asked to complete a survey at two separate times during the childs PICU hospitalization- 48-72 hours after admission and again upon transfer or discharge from the PICU Data will be collected about the child from the medical record including age diagnosisreason for PICU admission length of stay and any procedures performed in PICU requiring consent
Usual informed consent for procedures performed in the PICU is obtained immediately prior to the procedure Participants will be randomly assigned like the flip of a coin to either usual informed consent prior to each procedure or to a single consent form obtained upon admission to PICU for possible procedures their child may undergo In this study participants will be asked to complete a survey at two separate times during the childs PICU hospitalization- 48-72 hours after admission and again upon transfer or discharge from the PICU Data will be collected about the child from the medical record including age diagnosisreason for PICU admission length of stay and any procedures performed in PICU requiring consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None