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IRCT20100707004345N6 IRCT 2019-04-11 Rasht University of Medical Sciences The effect of melatonin on anxiety before hysterectomy Investigating the effect of melatonin on reducing preoperative anxiety in abdominal hysterectomy; a double blinded clinical trial study 2019-05-05 anticipated 80 Complete https://irct.ir/trial/38635 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: To produce random sequences in this clinical trial, we will use this site: http://www.graphpad.com/quickcalcs/index.cfm. A nurse who is not in the study, 90 minutes before surgery, will randomly divide patients into two groups by quadruple block method that includes: lorazepam + melatonin( dissolved in 20 milliliters sugar water) group and lorazepam+ sugar water group, Blinding description: A nurse who is not in the study randomly will divide patients into two groups and 90 minutes before surgery, for the intervention group, she will dissolve two melatonin pills in 20 milliliters of water. 2 sugar loaves will be added to it for not determining the taste. In the Control group, the same amount of sugar water is prescribed. After receiving the drug, the patient will be transferred to the recovery room and will be monitored to control blood pressure and heart rate. In this study, patients, the responsible anesthesiologist, and the information collector are BLIND. 3 Anxiety before abdominal hysterectomy surgery. Intervention 1: Intervention group: The group receiving lorazepam + Melatonin: Dosage of Melatonin for patients will be 6 milligrams based on previous studies. (3 milligrams tablets are available on the market, so two tablets are considered).(manufacturing Company: Aristo ).As the routine of this hospital is to prescribe 1miligramm lorazepam( manufacturing Company: Abidi)preoperative night for all patients candidate for hysterectomy, so both groups will receive this amount of lorazepam. (This treatment alone did not control anxiety in patients.)90 minutes Prior to surgery, a nurse who is not in the study will dissolve melatonin pills in 20 milliliters of water and will add 2 sugar loaves in order to not determine its taste. Intervention 2: Control group: The group receiving lorazepam + sugar water: preoperative night 1miligramm lorazepam( manufacturing Company: Abidi) will be given to patients.90 minutes prior to surgery,2 sugar loaves will be dissolved in 20 milliliters of water and it will be given to the patient by a nurse who is not in the study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is not decided yet
public Ali Mirmansouri
Heshmat Hospital, at the beginning of bayani street, Mosalla Square
Rasht Iran (Islamic Republic of) 4144654839 +98 13 1666 9064 a_mirmansoori@gums.ac.ir Rasht University of Medical Sciences scientific Ali Mirmansouri
Heshmat Hospital, at the beginning of bayani street, Mosalla Square
Rasht Iran (Islamic Republic of) 4144654839 +98 13 1666 9064 a_mirmansoori@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Candidate for elective abdominal hysterectomy Aged 30-65 30 years 65 years Female Major surgery for the past three years Chronic health problems like diabetes, cardiovascular disease Mood disorders (anxiety) that are under medication Addiction Malignant problems that cause hysterectomy Emergency hysterectomy F43 Reaction to severe stress and adjustment disorders Prevention Prevention Intervention group: The group receiving lorazepam + Melatonin: Dosage of Melatonin for patients will be 6 milligrams based on previous studies. (3 milligrams tablets are available on the market, so two tablets are considered).(manufacturing Company: Aristo ).As the routine of this hospital is to prescribe 1miligramm lorazepam( manufacturing Company: Abidi)preoperative night for all patients candidate for hysterectomy, so both groups will receive this amount of lorazepam. (This treatment alone did not control anxiety in patients.)90 minutes Prior to surgery, a nurse who is not in the study will dissolve melatonin pills in 20 milliliters of water and will add 2 sugar loaves in order to not determine its taste. Control group: The group receiving lorazepam + sugar water: preoperative night 1miligramm lorazepam( manufacturing Company: Abidi) will be given to patients.90 minutes prior to surgery,2 sugar loaves will be dissolved in 20 milliliters of water and it will be given to the patient by a nurse who is not in the study. Patient's anxiety before surgery. Timepoint: Before prescribing the drug, when patients enter the operating room and before the anesthetic induction. Method of measurement: Visual Aualogue scale. Blood pressure. Timepoint: Before prescribing the drug, when patients enter the operating room and before the anesthetic induction. Method of measurement: Manometer. Heart rate. Timepoint: Before prescribing the drug, when patients enter the operating room and before the anesthetic induction. Method of measurement: Monitoring. Rasht University of Medical Sciences Approved 2019-03-16 Ethics Committee Of Guilan University Of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street Rasht Guilan Iran (Islamic Republic of)