An interventional study of Eye masks and ear plugs in Sleep, Atrial Fibrillation and Delirium, Postoperative, sponsored by Amrita Institute of Medical Sciences & Research Center. Status unknown at 1 site in India. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Amrita Institute of Medical Sciences & Research Center · Not applicable, Interventional, and Prevention
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
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 100 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Amrita Institute of Medical Sciences & Research Center is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Eye masks and Ear plugs given during sleep
Device: Eye masks and ear plugs
Routine care given without any intervention
Eye masks and ear plugs given during sleeping time in Icu After cardiac surgery
Quality of sleep
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.
Time frame: 6 months
Atrial fibrillation
Postoperative atrial fibrillation
Time frame: 6 months
Delirium
Postoperative Delirium
Time frame: 6 months
Intensive care unit stay
Duration of intensive care unit stay (in hours to days)
Time frame: 6 months
Vasoactive inotropic score
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
Time frame: 6 months
Mechanical ventilation
Duration of mechanical ventilation (hours)
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Dec 2024, 5 months after the start.
Of 789 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 5 months is below that.
Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Amrita Institute of Medical Sciences & Research Center