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IRCT2012071810325N1 IRCT 2012-08-06 Vice chancellor for research and technology, Golestan university of Medical sciences Effect of structured auditory stimulation on the level of consciousness in patients' comatose with head trauma Effect of structured auditory stimulation on the level of consciousness in patients' comatose in intensive care unit with head trauma admitted to hospital 5th Azar 2012-07-25 anticipated 40 Complete https://irct.ir/trial/10818 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A comatose patients with head trauma. Intervention 1: Duration of intervention is 10 days and every day 3 times (in three shifts). Every auditory intervention is 15 minutes. A male nurse voice will be recorded and broadcasted for each patient as auditory stimulation. The content of auditory stimulation for each subject includes time, place, individual orientation, and individual demographic, family members’ demographic and professional condition. Intervention 2: In the control group ther is no intervention and patients recieve standard care.
public Gholamreza Mahmoodi Shan
kilometer 2 Gorgan-sari ,Gorgan, Iran.
Gorgan Iran (Islamic Republic of) 49165-568 +98 17 1442 6900 Mahmoudi@goums.ac.ir; Mahmoodigh@yahoo.com Golestan University of Medical Sciences scientific Gholamreza Mahmoodi Shan
kilometer 2 Gorgan-sari ,Gorgan, Iran.
Gorgan Iran (Islamic Republic of) 49165-568 +98 17 1442 6900 Mahmoudi@goums.ac.ir; Mahmoodigh@yahoo.com Golestan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: the admitted comatose patients in ICU with head trauma in the Panje Azar hospital of Gorgan , Iran who have the following criteria will be selected: GCS≤8, 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 (before 10 days, early discharge, disagreement of the responsible of patient for continuing of intervention, and auditory disorder. 15 years 60 years Both VI-S00-T98 Diseases of the nervous system-injury, poisoning and certain other consequences of external causes Prevention N/A Duration of intervention is 10 days and every day 3 times (in three shifts). Every auditory intervention is 15 minutes. A male nurse voice will be recorded and broadcasted for each patient as auditory stimulation. The content of auditory stimulation for each subject includes time, place, individual orientation, and individual demographic, family members’ demographic and professional condition. In the control group ther is no intervention and patients recieve standard care. Level of consciousness. Timepoint: One time in each shift ( 3 times per 24 hours). Method of measurement: GCS criteria. Blood pressure. Timepoint: 3 times in 24 hours. Method of measurement: blood pressure monitored based on mm Hg. Pulse. Timepoint: 3 times in 24 hours. Method of measurement: pulse rate( counting) per minute. Respiratory rate. Timepoint: 3 times in 24 hours. Method of measurement: counting respiratory rate per minute. O2 saturation. Timepoint: 3 times in 24 hours. Method of measurement: the percent of hemoglobine o2 saturatin. Vice chancellor for research and technology, Golestan university of Medical sciences Approved 2012-05-22 Ethical committee of Golestan university of Medical sciences Golestan university of Medical sciences; kilometer 2 Gorgan-sari ,Gorgan, Iran. Gorgan Iran (Islamic Republic of)