Sleep Bundle for Cardiac Surgery Patients
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a standardized sleep bundle can improve sleep for adults undergoing non-emergency heart surgery. Participants in the sleep bundle group will use non-drug sleep aids, such as a mask, ear plugs, and a noise machine, and may take sleep medication if needed. The researchers aim to determine if these methods enhance sleep quality and recovery compared to usual care. Suitable candidates for this trial are adults planning scheduled heart surgery with a heart-lung machine at the Saint John Regional Hospital, who do not have sleep apnea or regularly use certain sleep medications. As an unphased trial, this study offers participants the chance to contribute to innovative research that may enhance post-surgery recovery.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you use certain sleep medications regularly, you might not be eligible to participate. It's best to discuss your specific medications with the trial team.
What prior data suggests that this sleep bundle is safe for cardiac surgery patients?
Research has shown that using a sleep bundle for heart surgery patients is generally safe. Sleep bundles, which include items like sleep masks, ear plugs, and noise machines, have been used successfully with these patients and can even help reduce pain when used properly.
Regarding side effects, there is little cause for concern. The primary components of the sleep bundle are non-drug sleep aids, known for being well-tolerated. If necessary, sleep medications can be administered carefully to minimize risks. Overall, the sleep bundle aims to improve sleep quality without causing significant side effects.12345Why are researchers excited about this trial?
Researchers are excited about the Sleep Bundle for cardiac surgery patients because it combines non-drug strategies with carefully planned medication use to improve sleep. Unlike the usual postoperative care that mostly relies on standard routines, this approach specifically targets sleep issues, aiming to enhance recovery and overall well-being. They hope to find out if this protocol can provide better sleep quality, potentially leading to faster healing and improved patient outcomes after heart surgery.
What evidence suggests that this sleep bundle is effective for cardiac surgery patients?
Research has shown that a sleep bundle can improve sleep quality for patients after surgery. In this trial, participants in the Sleep Bundle Group will follow a standardized sleep management protocol, which includes non-drug sleep aids like masks and earplugs, along with the option for sleep medications. One study found that patients using a sleep bundle slept better than those who did not. These tools can help patients sleep longer, reduce nighttime awakenings, and enhance the perception of sleep quality. Improving sleep in hospitals can lead to fewer complications, such as reduced confusion, and possibly shorter hospital stays.12467
Who Is on the Research Team?
Caroline E Fitzpatrick
Principal Investigator
Horizon Health Network
Are You a Good Fit for This Trial?
Adults over 19 years old scheduled for non-emergency heart surgery with cardiopulmonary bypass at Saint John Regional Hospital can join. The trial is testing if a 'sleep bundle' helps patients sleep better after surgery compared to usual care.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the standardized sleep bundle or usual postoperative care
Follow-up
Participants are monitored for sleep quality and other clinical outcomes after treatment
Data Analysis
Data collected during the trial is analyzed to inform future studies
What Are the Treatments Tested in This Trial?
Interventions
- Standardized Sleep Bundle
Trial Overview
The study tests a 'sleep bundle' including sleep masks, ear plugs, noise machines, and stepwise use of sleep meds against standard post-op care. It checks if this improves sleep quality using daily questionnaires and Fitbit data.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in this group will receive a standardized sleep management protocol combining non-pharmacological interventions and stepwise pharmacotherapy.
Participants randomized to the control group will receive usual postoperative care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Horizon Health Network
Lead Sponsor
New Brunswick Heart Centre
Collaborator
Citations
Standardized Sleep Bundle for Cardiac Surgery Patients
This study is a pilot randomized controlled trial designed to evaluate the feasibility and effects of a standardized sleep bundle on sleep quality in patients ...
Implementing a Standardized Sleep Bundle in the ...
The 2020 HCAHPS revealed that patients scored the study site's cardiac division “2 out of 5 stars” under the “quietness of the environment at night.
The Effect of a Quality Improvement Intervention on Sleep and ...
Results: Compared with an 8- to 12-week preintervention baseline period, the 8- to 12-week intervention led to significant reductions in the proportion of days ...
Nursing‐Based Sleep Promotion Intervention Effectiveness ...
Extensive investigation of changes in QoS before and after cardiac surgery has reported that poor QoS is highly prevalent and is the most common ...
Non-pharmacological interventions to improve sleep quality ...
Evaluation of nonpharmacologic interventions and sleep outcomes in hospitalized medical and surgical patients: a nonrandomized controlled trial.
Optimizing Recovery in Cardiac Surgery: A Narrative Review ...
Overall, modern cardiac surgery has consistently demonstrated a high level of safety with minimal surgical complication rates, reflecting the ...
7.
scholarworks.uttyler.edu
scholarworks.uttyler.edu/cgi/viewcontent.cgi?article=1197&context=nursing_msnPrioritizing Sleep in the Cardiac-Surgical Patient
Sleep bundles have been effectively used with cardiac surgical patients. A sleep bundle even reduced pain when used correctly. The use of eye ...
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