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IRCT2014051517693N1 IRCT 2014-08-14 Vice-Chancellor for Research of Guilan University of Medical Sciences The effect of Organized auditory stimulation with familiar voices on the level of consciousness and hemodynamic status of coma patients The effect of Organized auditory stimulation with familiar voices on the level of consciousness and hemodynamic status of coma patients hospitalized in intensive care unit 2014-06-22 anticipated 60 Complete https://irct.ir/trial/16204 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A Head Trauma,Brain injury,Intracranial injury. Intervention 1: Organized auditory stimuli in the intervention group for 3 days,Once daily (evening shift) for 10 minutes With the voice of a person of interest to the patient becomes sick auditory stimulation.The content of auditory stimulation for each subject includes: awareness about the location, time,Briefly explain to the patient what has happened to him/her,Then the sweet memories shared and hopeful,optimistic and encouraging in terms of improved patient returned to his family and future plans will be discussed. Intervention 2: The control group did not receive intervention.
public Mohammad Kazem Mohammadi
Iran-Gilan-Rasht
Rasht Iran (Islamic Republic of) +98 13 1226 5049 Mohammadkm64@Gmail.com Guilan University of Medical Sciences scientific Mohammad Reza Yeganeh
Nursing & Midwifery Faculty, Guilan University of Medical Sciences, Daneshjoo St., Shahid Beheshti Ave., Rasht
Rasht Iran (Islamic Republic of) 41469-39814 +98 13 1555 5056 yeganeh@gums.ac.ir Guilan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: the admitted comatose patients in ICU with head trauma in the PourSina hospital of Rasht , Iran who have the following criteria will be selected: GCS≤8, Artificial airway (endotracheal tube - the mouth or nose - or tracheostomy), no have disorder or decrease in auditory function, no heart arrested for 4 minutes or upper, no having Precedence of : convulsion, brain damage, cardiovascular disease, fatty embolism, Rhinorrhea, otorrhea, fracture of basal skull, hemorrhage or surgery in temporal. exclusion criteria:Early death or discharge (before 3 days),Hemodynamic changes during intervention(A sudden increase or decrease in systolic and diastolic pressures over mmhg 20 compared to baseline,A sudden increase or decrease in heart rate over 20 beats to the base,Increased respiratory rate more than 25 and decreased more than 8 times per minute compared to the baseline) 16 years 139 years Both S09.7,S09. Multiple injuries of head,Other specified injuries of head,Intracranial injury Prevention N/A Organized auditory stimuli in the intervention group for 3 days,Once daily (evening shift) for 10 minutes With the voice of a person of interest to the patient becomes sick auditory stimulation.The content of auditory stimulation for each subject includes: awareness about the location, time,Briefly explain to the patient what has happened to him/her,Then the sweet memories shared and hopeful,optimistic and encouraging in terms of improved patient returned to his family and future plans will be discussed The control group did not receive intervention Level of consciousness. Timepoint: Once a day for three consecutive days. Method of measurement: GCS criteria. Blood pressure. Timepoint: Once a day for three consecutive days. Method of measurement: blood pressure monitoring based on mm Hg. Pulse. Timepoint: Once a day for three consecutive days. Method of measurement: pulse rate( counting) per minute by monitoring. Respiratory rate. Timepoint: Once a day for three consecutive days. Method of measurement: respiratory rate counting per minute. Body temperature. Timepoint: Once a day for three consecutive days. Method of measurement: With axillary thermometer based on C. Vice-Chancellor for Research of Guilan University of Medical Sciences Approved 2014-07-07 Guilan University of Medical Sciences Gillan - Rasht - Namjoo Street - opposite Azodi Stadium - Gilan University of Medical Sciences Rasht Iran (Islamic Republic of)