Impact of Sleep Quality on Outcomes After Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eye masks and ear plugs.
- Who it may be relevant to
- Registry conditions: Sleep, Atrial Fibrillation, Delirium, Postoperative, Complications, Postoperative. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effects of Non-pharmacological Interventions on the Quality of Sleep in Cardiac Surgical Patients
Overview
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
- Device Eye masks and ear plugs
Eye masks and ear plugs given during sleeping time in Icu After cardiac surgery
Primary outcome measures
- Quality of sleep [Time frame: 6 months]
Secondary outcome measures (5)
- Atrial fibrillation [Time frame: 6 months]
- Delirium [Time frame: 6 months]
- Intensive care unit stay [Time frame: 6 months]
- Vasoactive inotropic score [Time frame: 6 months]
- Mechanical ventilation [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
India · 1 center
- Dr. Nagarjuna — Kochi
Identifiers
NCT: NCT06527105 · IEC-AIMS-2023-CARDANES-009