Addmited ptients in the intensive care unit. Sleep disorders
Conditions
Interventions
Intervention 1: Intervention group:Tab melatonin, 3 mg, once a day at 9 pm, for 4 night, oral. Intervention 2: Control group: with out intervention.
Sponsors
Gonabad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Glasgow Coma Scale (GCS) score =10 patients with stable hemodynamic patients with out alcohol consumption =50 units per week or drug use(addiction) / narcotic or sedation drug order in icu haven't been used of drugs that might alter melatonin secretion and decrease plasma levels of melatonin, such as benzodiazepines, NSAIDs, corticosteroids, beta-blockers, haloperidol and amiodarone / sedation with propofol, morphine, alfentanil and dexmedetomidine has been discontinued for a minimum of 36 hours (48 hours for lorazepam and midazolam) before enter to study Apache II score 7 on the numerical scale of pain) for one hour before the prescribe of melatonin patients with out history of convulsions, psychiatric or neurological disease, deafness or blindness and the lack of any kind of sleep disorder such as sleep apnea, narcolepsy, chronic insomnia, restless legs syndrome (RLS) patients with out liver insufficiency and renal insufficiency (requires dialysis) patients with out severe heart failure (the New York Heart Association classification III/IV) patients with out intestinal obstruction, ileus or other conditions likely to affect the enteral absorption of melatonin Do not be pregnant or breast-feeding women more than 24 hours have passed from general anesthesia or hospitalization age =18 years old and = 60 years old
Exclusion criteria
Exclusion criteria: The incidence of gastrointestinal failure that prevents the absorption of melatonin, including obstruction and ileus The incidence of renal insufficiency (requires dialysis) The incidence of any kind of sleep disorder such as sleep apnea, narcolepsy over night sleep Pain scores above 7 on the numerical scale of pain during the intervention Lack of willingness to cooperate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Richards Campbell sleep questionaire score. Timepoint: before intervention, sixth night after addmited ( fourth night after intervention). Method of measurement: The person on the line specified in each of the 5 questions (Richards Campbell sleep questionaire score ) gives the best description of his or her sleep last night. The score for each question is between 0 and 100, which in total score is divided by 5 and between 0 and 100 points of sleep quality.;Glasgow coma score. Timepoint: before intervention and during the study. Method of measurement: According to the Glasgow coma score table (3-15) . The motor score is 6 points, the verbal score 5 points, and the visual score 4 points.;Pain scale (numerical/face). Timepoint: before intervention, during the study and sixth night after addmited ( fourth night after intervention). Method of measurement: The Visual Analogue Scale is a 10 cm vertical linear pain that is numbered from 0 to 10, or points to a symbolic face. Zero means \"completely pain free" and 10 means "maximum pain intensity". On a numerical scale, pain ratings are usually described as 0 -3 as mild pain, 4 to 6 as moderate pain, and 7 to 10 as severe pain.;Apache 2 score. Timepoint: The first 24 hours hospitalization. Method of measurement: The Apache 2 scale consists of three components: 1 - Acute physiology score ( APS )2 - Age adjustment3 - Chronic health evaluation (CHE). Finally, we summarize the scores obtained from all three components. Patients may receive 0 to 71 points. According to the standard table, if the patient's score is between 0, 15, 16 to 19, 20 to 30 and more than 30 points, the risk of death is 10, 15, 35 and > 75%, respectively. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMalihe Heydari
Gonabad University of Medical Sciences
Outcome results
None listed