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IRCT20191105045342N1 IRCT 2020-01-20 Gonabad University of Medical Sciences The effect of melatonin on sleep quality of patients in the intensive care unit The effect of oral melatonin on sleep quality of hospitalized patients in the intensive care unit 2019-12-16 anticipated 70 Complete https://irct.ir/trial/43470 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Addmited ptients in the intensive care unit. 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. Yes - There is a plan to make this available What will be shared: All data is shared after unidentifiable people When: Start accessing 6 months after publishing results To whom: For researchers working only in academic and scientific institutions Conditions: only major consequence Where to obtain: Send request to phone number : 0098 51 34526917 and email : heydarim10@gmail.com How to obtain: Email request in writing Comments:
public Malihe Heydari
No. 106, keshavarzi Ave, Sarallah Blvd, Sarakhs Town
Sarakhs Iran (Islamic Republic of) 9381737448 +98 51 3452 6917 heydarim10@gmail.com Gonabad University of Medical Sciences scientific Mohsen Saheban Maleki
Bohlool hospital, Sadi Ave., Parastar Blve., Gonabad
Gonabad Iran (Islamic Republic of) 7887906432 +98 51 5723 6833 dr.saheban@yahoo.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 < 35 and Estimated mortality < 75% patients with out severe pain level (pain 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 18 years 60 years Both 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 G47 Sleep disorders Treatment - Drugs N/A Intervention group:Tab melatonin, 3 mg, once a day at 9 pm, for 4 night, oral Control group: with out intervention 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. Gonabad University of Medical Sciences Approved 2019-12-31 Ethics committee of Gonabad University of Medical Sciences Bohlool hospital, Sadi Ave., Parastar Blvd., Gonabad Town Gonabad Razavi Khorasan Iran (Islamic Republic of)