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NCT03957317 · ClinicalTrials.gov registry record · NA
Improving Sleep Quality in Flap Patients in the SICU
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
NCT03957317 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 90 participants.
The verdict
NCT03957317, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
Study Summary
This investigation will be a randomized interventional prospective quality improvement study. Patients undergoing plastic surgery with flap procedures (n =123) will be randomized to evaluate the effect of the implementation bundle for sleep quality improvement in the surgical intensive care unit (SICU). Roughly one half of the patients (n =62) will be randomized to the intervention group. This group will receive the intervention bundle which consists of providing ear plugs and eye masks to patients and their family members. Roughly one half of the patients (n =62) will be randomized to the control group. This group will receive "usual care", which does not include ear plugs or eye masks and lacks specified times for laboratory draws and imaging studies. For each of the two groups, the investigators will collect Richards-Campbell Sleep Questionnaire (RCSQ) scores, Confusion Assessment Method for the ICU (CAM-ICU) scores, and modified Family Satisfaction in the Intensive Care Unit (FS-ICU) scores. The investigators will administer the RCSQ to these patients following every night they spend in the SICU and the FS-ICU questionnaire immediately prior to their discharge from the ICU.
Interventions
- OTHER Eye mask and ear plugs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2018-02-06 |
| Est. Completion | 2019-10-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03957317
The ClinicalTrials.gov registry entry for NCT03957317 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Eye mask and ear plugs is the first listed.
NCT03957317 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03957317 about?
NCT03957317 is a clinical study titled "Improving Sleep Quality in Flap Patients in the SICU". This investigation will be a randomized interventional prospective quality improvement study. Patients undergoing plastic surgery with flap procedures (n =123) will be randomized to evaluate the effect of the implementation bundle for sleep quality improvement in the surgical intensive care unit (SI...
What is the current status of trial NCT03957317?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2018-02-06. Estimated completion is 2019-10-05.
What interventions are being tested in trial NCT03957317?
The interventions under investigation include: Eye mask and ear plugs (OTHER).
Who is sponsoring clinical trial NCT03957317?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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