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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: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT03957317 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 90 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Richards-Campbell Sleep Questionnaire (RCSQ) is a 5-item questionnaire used to evaluate perceived sleep depth, sleep latency, number of awakenings, efficiency, and sleep quality. Each RCSQ question is measured on a 0 (minimum) to 100 (maximum) visual-analogue scale, with higher scores representing better sleep. The primary outcome measure is a 25% increase in median RCSQ scores from the control group.
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 |
What the finished NCT03957317 record still lists
NCT03957317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Eye mask and ear plugs is the first listed.
NCT03957317 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03957317's enrollment target sits among peer trials
90 941st of 2000 higher than 1,029 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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