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IRCT20160308026961N5 IRCT 2018-07-04 Vice chancellor for research of Kermanshah University of Medical Sciences The effect of planned sensory stimulation on the level of consciousness ,vital signs and Oxygen saturation in patients in patients admitted to the ICU The effect of planned sensory stimulation performed by family members and nurses on the level of consciousness ,vital signs and Oxygen saturation in patients admitted to Intensive care unit 2018-05-10 anticipated 115 Complete https://irct.ir/trial/22222 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with stratified blocking method (based on the age group with 10 years distance, 16 to 25, 26 to 35, 36 to 45, 46 to 55, and 56 to 65) will be randomly divided into three groups and within each block, half of the intervening and half-blind individuals are considered as witnesses to balance the number of participants in each of the groups, Blinding description: In this study, patients and outcome evaluators will be blinded to the study groups. 2-3 Patients with head trauma. Intervention 1: The first intervention group will receive sensory stimulation by a family member every day for 2 hours, from 4 to 5 in the evening and 8 to 9 in the night with 3 hours distance and for 6 days. Sensory stimulation program includes sight, auditory, smell, touch and kinesthetic stimulation. Olfactory stimulating by taking alcohol in front of the patient's nose for 5 seconds, sight stimulating by turning the flashlight on and off in front of the patient's eyes for 2 seconds,auditory stimulation by calling the patient's own name, time, place and day near the patient's ear three times,touch stimulating by squeezing and massage and rub the skin with cotton and guas, first, one side of the body and then the other side, kinesthetic stimulation by moving the joints of the hands and feet, the wrist, the hip joint and shoulder joint by bending and straightening, and alternating up and down the arms and legs 15 times, and each of the stimuli is performed once per hour. Intervention 2: The second intervention group will receive sensory stimulation by researcher every day for 2 hours, from 4 to 5 in the evening and 8 to 9 in the night with 3 hours distance and for 6 days. Sensory stimulation program includes sight, auditory, smell, touch and kinesthetic stimulation. Olfactory stimulating by taking alcohol in front of the patient's nose for 5 seconds, sight stimulating by turning the flashlight on and off in front of the patient's eyes for 2 seconds,auditory stimulation by calling the patient's own name, time, place and day near the patient's ear three times,touch stimulating by squeezing and massage and rub the skin with cotton and guas, first, one side of the body and then the other side, kinesthetic stimulation by moving the joints of the hands and feet, the wrist, the hip joint and shoulder joint by bending and straightening, and alternating up and down the arms and legs 15 times, and each of the stimuli is performed once per hour. Intervention 3: The control group will not receive any sensory stimulation. Yes - There is a plan to make this available What will be shared: The main outcomes of the study will be shared. When: 6 months To whom: If requested, results will be made available to other academic researchers Conditions: Collected data is confidential and will not be shared with anyone else Where to obtain: To receive the documentation, email send for update manager How to obtain: In a 15-day period, the documents will be sent e-mail Comments:
public Shila Amini
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 834276301 k.vafaee1360@gmail.com Emam Reza Hospital scientific Kamran Vafaee
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6301 k.vafaee1360@gmail.com Emam Reza Hospital Iran (Islamic Republic of) Visitors are only the main members of the family (father, mother, spouse, child, sister, brother) and their age is over 18 years of age. Patients is hospitalized with head trauma (Types of brain hematomas and other lesions, except diffuse axon damage) The patient has pupil reflexes at the entrance to the ICU section. The level of patients consciousness be between 6 and 12 The patient already has no history of mental illness, GCS fluctuations within a few days prior to the trauma (the Delirium term in this research) It has not been more than 3 days passed since the patient's admitted to the Intensive Care Unit 16 years 65 years Both History of admission to a psychiatric hospital Visitors younger than 18 years of age S09.9 Unspecified injury of head Treatment - Other Treatment - Other Other The first intervention group will receive sensory stimulation by a family member every day for 2 hours, from 4 to 5 in the evening and 8 to 9 in the night with 3 hours distance and for 6 days. Sensory stimulation program includes sight, auditory, smell, touch and kinesthetic stimulation. Olfactory stimulating by taking alcohol in front of the patient's nose for 5 seconds, sight stimulating by turning the flashlight on and off in front of the patient's eyes for 2 seconds,auditory stimulation by calling the patient's own name, time, place and day near the patient's ear three times,touch stimulating by squeezing and massage and rub the skin with cotton and guas, first, one side of the body and then the other side, kinesthetic stimulation by moving the joints of the hands and feet, the wrist, the hip joint and shoulder joint by bending and straightening, and alternating up and down the arms and legs 15 times, and each of the stimuli is performed once per hour The second intervention group will receive sensory stimulation by researcher every day for 2 hours, from 4 to 5 in the evening and 8 to 9 in the night with 3 hours distance and for 6 days. Sensory stimulation program includes sight, auditory, smell, touch and kinesthetic stimulation. Olfactory stimulating by taking alcohol in front of the patient's nose for 5 seconds, sight stimulating by turning the flashlight on and off in front of the patient's eyes for 2 seconds,auditory stimulation by calling the patient's own name, time, place and day near the patient's ear three times,touch stimulating by squeezing and massage and rub the skin with cotton and guas, first, one side of the body and then the other side, kinesthetic stimulation by moving the joints of the hands and feet, the wrist, the hip joint and shoulder joint by bending and straightening, and alternating up and down the arms and legs 15 times, and each of the stimuli is performed once per hour The control group will not receive any sensory stimulation. The level of consciousness. Timepoint: 10 minutes before the intervention and 30 minutes after the intervention. Method of measurement: Using the Glasgow Coma Scale (GCS). Vital signs. Timepoint: 10 minutes before the intervention and 30 minutes after the intervention. Method of measurement: Using a cardio-respiratory monitoring device and an oxilary thermometer. Arterial oxygen saturation. Timepoint: 10 minutes before the intervention and 30 minutes after the intervention. Method of measurement: Using a cardio-respiratory monitor. Vice chancellor for research of Kermanshah University of Medical Sciences Approved 2016-11-23 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti, Kermanshah Kermanshah Iran (Islamic Republic of)