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IRCT20171024036979N1 IRCT 2017-12-08 Student Research Committee, Vice Chancellor for research and technology of Kurdistan University of M The effect of pleasant sound stimulation on hemodynamic parameters, the agitation and level of Consciousness in comatose patient The effect of pleasant sound stimulation on hemodynamic parameters, the agitation and level of Consciousness in comatose patient in Intensive Care Units 2017-12-11 anticipated 80 Complete https://irct.ir/trial/27483 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients eligible for 2 randomized intervention and control groups will be assigned randomly, using packets in envelopes, envelopes 1 for intervention and 2 for control, Blinding description: To blind the study, the first research assistant intervened and due to wearing headphones in the two groups the second researcher would not be able to differentiate between the intervention group and control group. After wearing headphones, regardless of the type of group, he will collect the information. N/A Coma. Intervention 1: Control group: In this group, headphones are worn by patients (with playing no sound) without any other stimuli for 10 minutes for a week. Intervention 2: Intervention group: In this group, sound stimuli pleasant for patients are played for 10 minutes for one week with headphones without any other stimuli. Undecided - It is not yet known if there will be a plan to make this available
public Farzad Rahimi
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
ُSanandaj Iran (Islamic Republic of) 13446-66177 +98 87 3366 0092 F.Rahimi@muk.ac.ir Vice Chancellor for research and technology of Kurdistan University of Medical Sciences scientific Jamal Seidi
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
Sanandaj Iran (Islamic Republic of) 66177-13446 +98 87 3182 7464 Jamal.seidi@muk.ac.ir Kurdistan University of Medical Sciences Iran (Islamic Republic of) Alertness level equal to and less than 8 according to Glasgow Patients aged 15-75 years 24Hours after vital signs are sustained in the intensive care unit Not taking antidepressants or affecting restlessness and tranquilizers and Opiums Absence of mental disorders No previous brain damage No impairment or hearing loss Lack of cerebrospinal fluid or blood from the ears and nose Non-fracture, bleeding and temporal and temporal area surgery No addiction Not getting cancer Lack of fracture in four limbs or quadriplegic No significant changes in intracranial pressure 15 years 75 years Both Discharge or death of the patient before day 6 Cancellation of the patient's continuation of the study Severe changes in vital signs Severe changes in mental status Severe changes in intracranial pressure Destruction of brain stem reflex during research R40.2 Unconsciousness NOS Other Other Control group: In this group, headphones are worn by patients (with playing no sound) without any other stimuli for 10 minutes for a week. Intervention group: In this group, sound stimuli pleasant for patients are played for 10 minutes for one week with headphones without any other stimuli. Hemodynamic parameters. Timepoint: Before, immediately and ten minutes after the intervention. Method of measurement: Systole and diastolic blood pressure with mercuric pressure gauge, moderate blood pressure with the corresponding formula, pulse pressure by decreasing systole pressure from diastol, oxygen saturation with plusoxymmeters. Agitation. Timepoint: Before, immediately and ten minutes after the intervention. Method of measurement: Using Richmond Agitation-Sedation Scale (RASS). Level of consciousness. Timepoint: Before, immediately and ten minutes after the intervention. Method of measurement: Using the Glasgow coma scale (GCS). Student Research Committee, Vice Chancellor for research and technology of Kurdistan University of M Approved 2017-10-07 Ethic committee of Kurdistan University of Medical Sciences Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj Sanandaj Kurdistan Iran (Islamic Republic of)