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IRCT20180731040658N2 IRCT 2018-10-15 Qazvin University of Medical Sciences The effect of the vibration on the level of consciousness in head trauma patients The effect of the vibration on the level of consciousness in head trauma patients 2017-05-22 anticipated 50 Complete https://irct.ir/trial/33965 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple random sampling At first, the random allocation of samples was done for two groups of control and intervention using a two-ball orbital draw, so that the white ball indicates the control group and the red ball indicates the intervention group. N/A Head trauma patients. Intervention 1: Intervention group: Performing vibration with 50 Hz Frequency of legs from fingers to ankles using a jacuzzi massager machine Made in China once a day for 15 minutes after an appointment and for 7 consecutive days. Intervention 2: Control group: Control group: In the control group, the usual care was taken in all centers. In the control group, the level of consciousness and vital signs parallel to the intervention group was evaluated and recorded. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information
public Fateme Nazifi
No. 92, Alley 33, Shahid Babaei Street
Qazvin Iran (Islamic Republic of) 3414678113 +98 28 3368 5170 f.nazifi@qums.ac.ir Qazvin University of Medical Sciences scientific Fateme Nazifi
No. 92, Alley 33, Shahid Babaei Street
Qazvin Iran (Islamic Republic of) 3414678113 +98 28 3368 5170 f.nazifi@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) patients with head trauma with a level of consciousness of 5 – 12 age of 17-65 years patients who at least 72 hours have passed since their injury SIMV mod For patients connected to the ventilator 17 years 65 years Both head trauma patients who based on records and history have a history of the diabetes, a history of coma in the past and a history of sensory and neurological disorders fracture, ulcer, infection and skin disease in the wrist to the extremities of both feet fingers, limitation of movement of the lower limbs lower limb amputation Patients receiving infusion of sedation medication can not be stopped death S00.90XA Unspecified superficial injury of unspecified part of head, initial encounter Rehabilitation N/A Intervention group: Performing vibration with 50 Hz Frequency of legs from fingers to ankles using a jacuzzi massager machine Made in China once a day for 15 minutes after an appointment and for 7 consecutive days Control group: Control group: In the control group, the usual care was taken in all centers. In the control group, the level of consciousness and vital signs parallel to the intervention group was evaluated and recorded Level of consciousness. Timepoint: Control the level of consciousness before, one and three hours after the intervention with vibration. Method of measurement: GCS Scale. Qazvin University of Medical Sciences Approved 2017-04-15 Ethics Committee of Qazvin University of Medical Sciences Qazvin University of Medical Sciences, Bahonar Blvd Qazvin Qazvin Iran (Islamic Republic of)