N/A
N=333
Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit
Stress
Bottom Line
View on ClinicalTrials.gov: NCT04697173 ↗Enrolled (actual)
333
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Parent/Caregiver Stress 48 to 72 Hours Following Admission to the Pediatric ICU — 9; 8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Single consent (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parent/Caregiver Stress 48 to 72 Hours Following Admission to the Pediatric ICU |
9; 8 | — |
| SECONDARY Number of Procedures Performed Without Appropriately Documented Consent |
11; 9 | — |
| SECONDARY Parent/Caregiver Stress at Time of Discharge From the Pediatric ICU |
3; 3 | — |
Summary
The purpose of this research study is to find out about how obtaining consent for procedures in the PICU affects parental/caregiver 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.
Eligibility Criteria
Inclusion Criteria
- Parents/caregivers (>18 years) of children admitted to the Pediatric ICU during the designated study period
Exclusion Criteria
- Anticipated length of PICU stay < 24 hours
- Non-English speaking parents/caregivers
Data sourced from ClinicalTrials.gov (NCT04697173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.