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NCT04697173 · ClinicalTrials.gov registry record · NA
Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit
A NA study of Stress, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- NA
- Development phase
- 333
- Enrollment target
- 1
- Study location
NCT04697173: Completed NA study of Stress, sponsored by Virginia Commonwealth University.
NCT04697173 is a NA study of Stress that has completed, run by Virginia Commonwealth University. The registered enrollment target is 333 participants, below the 784-participant average among 152 other Stress trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04697173, a NA study of Stress, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- NA
- Development phase
- 333 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Stress will be assessed using the Short Stress Overload Scale (SOS-S). The SOS-S is a 10 item questionnaire. Items are rated not at all (1) to a lot (5). Ratings are assigned a score and the scores are summed. Summed scores range from 10 - 50 with higher scores indicating greater stress. The SOS-S generates two subscores, Personal Vulnerability (PV) and Event Load (EL), with a score range from 5 to 25 for each. An individual's PV score corresponds to that individual's readiness to take on new st
Conditions Studied
Interventions
- OTHER Single consent
Study Locations (1)
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2021-01-13 |
| Est. Completion | 2022-06-26 |
| Phase | NA |
What the finished NCT04697173 record still lists
NCT04697173 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, below the 784-participant average among 152 other Stress trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Stress appearing as the primary indexed condition, and to 1 intervention - of which Single consent is the first listed.
NCT04697173 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04697173 about?
NCT04697173 is a clinical study titled "Bundle Consent and Expectation Setting in Pediatric Intensive Care Unit". 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 p...
What is the current status of trial NCT04697173?
This trial is currently completed. It is a NA study. The enrollment target is 333 participants. The study started on 2021-01-13. Estimated completion is 2022-06-26.
What conditions does trial NCT04697173 study?
This clinical trial studies the following conditions: Stress.
What interventions are being tested in trial NCT04697173?
The interventions under investigation include: Single consent (OTHER).
Who is sponsoring clinical trial NCT04697173?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04697173 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04697173's enrollment target sits among peer trials
333 16th of 152 higher than 137 of 152 other Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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