Impact of Sleep Quality on Outcomes After Cardiac Surgery
The Effects of Non-pharmacological Interventions on the Quality of Sleep in Cardiac Surgical Patients
Sleep is a basic human need and is essential for good quality of life, good health. In fact, humans spend one third of their life time in sleeping or attempting to do so. However, sleep is not given due importance in intensive care unit (ICU)'s, although it is critical in healing process. Patient's usually get admitted to the hospital few days prior to the surgery, for complete evaluation, depending on the procedure planned. Hospital environment being, an entirely new place for inpatients, will invariably affect their sleep. Sleep deprivation is one of the major sources of anxiety and stress in all the patients during ICU stay. This means that most of patients are sleep deprived, by the time they are admitted to ICU.
The negative effects of sleep deprivation include postoperative brain dysfunction like inattention, restlessness, hallucinations, agitation, aggressiveness. The degree of cognitive impairment may range from subtle derangements in attention, reason, clarity of thought and capacity of decision making to confusion and delirium. Sleep deprivation can also induce hypertension, fatigue, metabolic disorders, cerebrovascular and cardiovascular disease
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nagarjuna P, MD, DM
- Phone Number: 091 9177208286
- Email: drarjun83@gmail.com
Study Contact Backup
- Name: Nagarjuna P
- Phone Number: 7981144584
Study Locations
-
-
Kerala
-
Kochi, Kerala, India, 682041
- Recruiting
- Dr. Nagarjuna
-
Contact:
- Nagarjuna P, MD, DM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult cardiac surgical patients aged above 18years undergoing elective cardiac surgery
Exclusion Criteria:
- Not willing to give consent
- Preoperative sleep medications use
- Preoperative psychological disorders, on mechanical ventilation for >12hrs, dementia, cerebrovascular accident
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Interventional group
Eye masks and Ear plugs given during sleep
|
Eye masks and ear plugs given during sleeping time in Icu After cardiac surgery
|
|
No Intervention: Control group
Routine care given without any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of sleep
Time Frame: 6 months
|
On the morning after the intervention, patient's sleep quality will be assessed using Richard-Campbell sleep questionnaire (RCSQ).
Each point in RCSQ will be scored using a visual analog score, ranging from 0-100.
Total score will be calculated and then will be divided by 5.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Atrial fibrillation
Time Frame: 6 months
|
Postoperative atrial fibrillation
|
6 months
|
|
Delirium
Time Frame: 6 months
|
Postoperative Delirium
|
6 months
|
|
Intensive care unit stay
Time Frame: 6 months
|
Duration of intensive care unit stay (in hours to days)
|
6 months
|
|
Vasoactive inotropic score
Time Frame: 6 months
|
Vasoactive inotropic score is calculated by multiplying the dose of each vasoactive drug used with 10. (minimum score is 0, while maximum score can go upto 20.
Higher the score worse is the outcome
|
6 months
|
|
Mechanical ventilation
Time Frame: 6 months
|
Duration of mechanical ventilation (hours)
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IEC-AIMS-2023-CARDANES-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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