Improving Sleep Quality in Flap Patients in the SICU
Completed · Not applicable
Conditions studied: Sleep Deprivation
In brief
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.
Key facts
- Study ID
- NCT03957317
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 90
- Starts
- 2018-02-06
- Expected to finish
- 2019-10-05
- Last updated by the study team
- 2019-10-14
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients age ≥ 18 years
- Individuals undergoing plastic surgery flap procedures requiring hourly monitoring
You may not qualify if…
- Pregnancy
- Incarceration
- Diagnosis of obstructive sleep apnea
- Diagnosis of insomnia or other sleep disturbance
Where it is running
- UT Southwestern Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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