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IRCT20100816004578N8 IRCT 2020-05-12 Hamedan University of Medical Sciences Effect of Melatonin on prevention of delirium Effect of Melatonin on the incidence of delirium in patients admitted to the intensive care unit: A randomized controlled clinical trial 2019-08-23 anticipated 140 Complete https://irct.ir/trial/46404 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization (groups of 2) will be performed using random numbers list generated by Random Allocation Software © (RAS; Informer Technologies, Inc., Madrid, Spain). The numbers will be placed into sequential containers that will be kept in a secure location until allocation consignment. Enrollment and randomization will be occurred in the emergency department from available admitted ICU patients on a convenience basis. Only patients will be admitted to the ICU through the emergency department will be eligible for inclusion. The consignment will be implemented though: A person who divides patients into control and intervention groups will not be aware of the grouping of individuals, Blinding description: To ensure blinding, the allocation sequence will be created by a different investigator than the one enrolling participants. A third investigator will be responsible for patient follow-up and assessments. Patients will not know what group they are in. Patients, researchers, and data collectors will not be aware of patient grouping. The two intervention and control groups will not be specified for the statistician. The medication regimen of the intervention and control groups has different pills, the intervention group patients will not know which pill is Melatonin. 2-3 Delirium. Intervention 1: Intervention group: Melatonin 3 mg tablet, orally at 9 p.m, every night for one week or till discharge from ICU + Receiving standard treatment of the intensive care unit. Intervention 2: Control group: Receiving standard treatment of the intensive care unit. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Farshid Rahimi-Bashar
General ICU, Besat Hospital, Shahid Motahhari boulevar, Hamadan
Hamadan Iran (Islamic Republic of) 6514845411 +98 81 3264 0047 fr_rahimibashar@yahoo.com Hamedan University of Medical Sciences scientific Farshid Rahimi-Bashar
General ICU, Besat Hospital, Shahid Motahhari boulevar, Hamadan
Hamadan Iran (Islamic Republic of) 65148454411 +98 81 3264 0047 fr_rahimibashar@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Ages 17 to 70 years Having the power of communication RASS score equal to or greater than -3 Hospitalized for at least seven days in ICU ward 18 years 75 years Both Vision and hearing problems History of mental disorders such as psychosis and mental retardation History of antipsychotic medication use F05 Delirium due to known physiological condition Prevention N/A Intervention group: Melatonin 3 mg tablet, orally at 9 p.m, every night for one week or till discharge from ICU + Receiving standard treatment of the intensive care unit Control group: Receiving standard treatment of the intensive care unit Delirium incidence. Timepoint: Daily. Method of measurement: Confusion Assessment Method for the ICU (CAM-ICU); Intensive Care Delirium Screening Checklist (ICDSC). Number of admission days. Timepoint: after discharge from hospital. Method of measurement: patient's records. Hamedan University of Medical Sciences Approved 2019-12-07 Ethics Committee of Hamedan University of Medical Sciences Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan Hamadan Hamadan Iran (Islamic Republic of)