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Clinical Trials/NCT06527105
NCT06527105
Recruiting
Not Applicable

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

Amrita Institute of Medical Sciences & Research Center1 site in 1 country60 target enrollmentJuly 22, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep
Sponsor
Amrita Institute of Medical Sciences & Research Center
Enrollment
60
Locations
1
Primary Endpoint
Quality of sleep
Status
Recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
July 22, 2024
End Date
January 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Amrita Institute of Medical Sciences & Research Center
Responsible Party
Principal Investigator
Principal Investigator

Nagarjuna P

Assistant Professor, Department of Cardiac Anesthesia

Amrita Institute of Medical Sciences & Research Center

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Atrial fibrillation(6 months)
  • Vasoactive inotropic score(6 months)
  • Mechanical ventilation(6 months)
  • Delirium(6 months)
  • Intensive care unit stay(6 months)

Study Sites (1)

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