Actively Recruiting
The Effects of Non-pharmacological Interventions on the Quality of Sleep in Cardiac Surgical Patients
Led by Amrita Institute of Medical Sciences & Research Center · Updated on 2024-09-25
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Sleep is a vital human need essential for good health and quality of life, yet it is often overlooked in intensive care units (ICUs) where patients experience significant sleep deprivation. This deprivation can lead to negative effects such as brain dysfunction, including inattention, restlessness, hallucinations, agitation, and cognitive impairments ranging from confusion to delirium. It may also contribute to hypertension, fatigue, metabolic disorders, and cardiovascular complications, especially in patients undergoing cardiac surgery. This research evaluates the impact of non-drug interventions using eye masks and ear plugs during sleep in the ICU after cardiac surgery. Patients are randomly assigned to either receive these devices during sleep or to receive routine care without any intervention. The study compares sleep quality and postoperative complications across these groups over a six-month period. Participants will be monitored for sleep quality and other health outcomes such as atrial fibrillation, delirium, ICU stay length, vasoactive inotropic score, and mechanical ventilation duration. The study involves follow-up assessments over six months to understand how these interventions affect recovery and complications after cardiac surgery. The trial is sponsored by Amrita Institute of Medical Sciences & Research Center and includes adults aged 18 to 80 years undergoing elective cardiac surgery.
CONDITIONS
Brief Title
Impact of Sleep Quality on Outcomes After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult cardiac surgical patients aged above 18 years undergoing elective cardiac surgery
You will not qualify if you...
- Not willing to give consent
- Use of sleep medications before surgery
- Presence of psychological disorders before surgery
- Mechanical ventilation for more than 12 hours
- Dementia
- History of cerebrovascular accident
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During hospital stay post-surgery
Participants undergo elective cardiac surgery and receive either eye masks and ear plugs during sleep in the ICU or routine care without intervention.
Daily assessments during ICU stay
Duration - 6 months
Participants are observed for outcomes including quality of sleep, atrial fibrillation, delirium, ICU stay, vasoactive inotropic score, and mechanical ventilation over 6 months.
Periodic visits or contacts over 6 months
Trial Site Locations
Total: 1 location
1
Dr. Nagarjuna
Kochi, Kerala, India, 682041
Actively Recruiting
Research Team
N
Nagarjuna P, MD, DM
N
Nagarjuna P
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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