Skip to content

Impact of Sleep Quality on Outcomes After Cardiac Surgery

The Effects of Non-pharmacological Interventions on the Quality of Sleep in Cardiac Surgical Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06527105
Enrollment
100
Registered
2024-07-30
Start date
2024-07-22
Completion date
2025-01-31
Last updated
2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Complications, Postoperative, Delirium, Postoperative, Sleep

Keywords

Cardiac surgery, Sleep quality

Brief summary

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

Interventions

Eye masks and ear plugs given during sleeping time in Icu After cardiac surgery

Sponsors

Amrita Institute of Medical Sciences & Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of sleep6 monthsOn 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.

Secondary

MeasureTime frameDescription
Atrial fibrillation6 monthsPostoperative atrial fibrillation
Delirium6 monthsPostoperative Delirium
Intensive care unit stay6 monthsDuration of intensive care unit stay (in hours to days)
Vasoactive inotropic score6 monthsVasoactive 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
Mechanical ventilation6 monthsDuration of mechanical ventilation (hours)

Countries

India

Contacts

Primary ContactNagarjuna P, MD, DM
drarjun83@gmail.com9177208286
Backup ContactNagarjuna P
7981144584

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026