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IRCT20120414009469N4 IRCT 2021-05-08 Ahvaz University of Medical Sciences The effect of implementing sensory stimulations program on clinical outcomes of brain injury patients admitted in Intensive Care Unit The effect of implementing sensory stimulations program on clinical outcomes of brain injury patients admitted in Intensive Care Unit 2021-06-21 anticipated 66 Complete https://irct.ir/trial/55583 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, based on the inclusion and non-inclusion criteria, the participants are selected and then will be allocated randomly in two groups of intervention and control by Stratified randomization method. First, categories are created based on age group with an interval of 10 years (18 - 27, 28 - 37, 38 - 47, 47 - 57 and 58 - 67 years) and then in each category, a random sequence will be created by using a table of random numbers. In this way, after survey the patients in terms of inclusion criteria, each of them will have a number based on the order of inclusion in the study. These numbers will be selected using a random number table. The researcher will randomly place his hand on a point in the table of random numbers and then will separate the numbers in pairs from left to right. Numbers will be selected that fall within the sample size range. Even numbers will be considered for the intervention group and odd numbers for the control group. N/A Condition 1: Head trauma. Condition 2: Head trauma. Condition 3: Head trauma. Condition 4: Head trauma. Condition 5: Head trauma. Condition 6: Brain Injury. Intervention 1: Intervention group: Sensory simulations program (Include: olfactory stimulation, auditory stimulation, Vision Stimulation, Tactile stimulation, Motor stimulation, awakening stimulation) will be implemented once a day, Between 4 and 5 p.m. and each time for 60 minutes during hospitalization in the intensive care unit. Intervention 2: Control group: There will be no intervention in the control group, and patients will be received routine care. In routine care, sensory stimulation is usually not performed for patients and there is no specific protocol for this. Yes - There is a plan to make this available What will be shared: All details of the data will be shared without the identification of the person being investigated by maintaining ethical principles. When: Start the access period immediately after publishing the results To whom: It will be accessible to everyone Conditions: A certain condition will not be considered at this time. Where to obtain: Researcher Email How to obtain: Only by visiting the central library of Ahwaz University of Medical Sciences and providing a valid identification card will be available. Comments:
public Mohammad Adineh
Padadshahr, 19th East St., Omid Complex, Ahvaz.
Ahvaz Iran (Islamic Republic of) 6184813161 +98 61 3554 2036 mohadineh@gmail.com Ahvaz University of Medical Sciences scientific Mohammad Adineh
Padadshahr, 19th East St., Omid Complex, Ahvaz.
Ahvaz Iran (Islamic Republic of) 6184813161 +98 61 3554 2036 mohadineh@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) The patient with brain injury Intubated and under ventilator GCS score between 6 and 12 having pupillary reflex Age between 18 and 67 years. 18 years 67 years Both Having a history of mental illness and hospitalization in a mental hospital; More than 2 days have passed since the patient is admitted to the ICU; Having a history of debilitating underlying diseases such as kidney, heart and liver failure; History of alcohol and opioid addiction; Having delirium S06.3 S06.2 S06.4 S06.5 S06.6 S06 Focal traumatic brain injury Diffuse traumatic brain injury Epidural hemorrhage Traumatic subdural hemorrhage Traumatic subarachnoid hemorrhage Intracranial injury Other Other Intervention group: Sensory simulations program (Include: olfactory stimulation, auditory stimulation, Vision Stimulation, Tactile stimulation, Motor stimulation, awakening stimulation) will be implemented once a day, Between 4 and 5 p.m. and each time for 60 minutes during hospitalization in the intensive care unit. Control group: There will be no intervention in the control group, and patients will be received routine care. In routine care, sensory stimulation is usually not performed for patients and there is no specific protocol for this. Type and Incidence rate of delirium. Timepoint: During the patient's hospitalization in the ICU, Daily. Method of measurement: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Severity of pain. Timepoint: 5 minutes before intervention and 5 minutes after intervention. Method of measurement: Behavioral Pain Scale. Consciousness level. Timepoint: 5 minutes before intervention and 5 minutes after intervention. Method of measurement: Glasgow coma score. Dependence on mechanical ventilation period. Timepoint: Number of days dependence on mechanical ventilation. Method of measurement: Checklist. Incidence rate of death. Timepoint: During hospitalization time. Method of measurement: Checklist. Hospitalization period in Intensive Care Unit. Timepoint: Number of days hospitalized in Intensive Care Unit. Method of measurement: Checklist. Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences Approved 2021-04-10 Ethics Committee of Jundishapur Ahvaz University of Medical Sciences Esfand St, Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)