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IRCT20191230045944N1 IRCT 2020-03-26 Shiraz University of Medical Sciences The effect of hearing stimuli (familiar sounds and preferred music) on intracranial blood pressure level, level of consciousness, cortisol level and vital signs of severe head injury patients. The effect of hearing stimuli (familiar sounds and preferred music) on intracranial blood pressure level, level of consciousness, cortisol level and vital signs of severe head injury patients. 2013-09-23 anticipated 54 Complete https://irct.ir/trial/46136 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Fifty-four patients were divided into three groups of 18 (control, preference music, and familiar voice) using simple randomization via dice throwing. Dice numbers 1 and 2 were used for the control group, 3 and 4 for the familiar group, and 5 and 6 for the preferred music group. The throw of the dice continued until the end of the sampling. For whatever reason, if the patient were removed from any group, the dice would be thrown again. And by inserting headphones and MP3 for the patient by the researcher, blinding the outcome collector was done, Blinding description: The data collector was not aware of the type of groups, and the accuracy of the MPTRIs and Freemasons geometry was verified by the researcher. N/A Patients with severe head injury. Intervention 1: First intervention group: Familiar voices were heard for thirty minutes. Which, based on the patient's family history, recorded the most intimate voice of the patient in a quiet environment. And there was no whimper or cryingwhen recording the sound.While talking to the patient several times, they called the patient by the name they were calling home and in their intimate surroundings. And the person who was recording his voice introduced himself to the patient in his own cultural language at the beginning of the recording. She told the patient what had happened to her and was admitted to the intensive care unit. And he assured the patient to keep track of his treatment and return to health. And they talked about what was going on in the last month and what they were going to do after the patient recovered. Intervention 2: Control group: These patients were receiving routine care in the intensive care unit, and no other new work was being done in the twelve days they were monitored. The headphone was used for thirty minutes for this group of patients who did not make any noise to ensure that the outcome collector was not aware of the control group. Intervention 3: Preferred Music group:The patient's favorite music sound was played for thirty minutes based on the patient's family history of using the headphones. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared When: Access started 6 months after printing. To whom: All interested people in academic, scientific and industrial institutions have permission to use. Conditions: Systematic review and ongoing research in this field Where to obtain: parvin delavari; parvin.delavari@yahoo.com How to obtain: Apply via e-mail Comments:
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Shiraz Iran (Islamic Republic of) 00987133613546 00982346313 parvin.delavari@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) People between 18 and 60 years Informed consent of the patient's family, Glasgow coma score between 3 and 8, Vital signs are constant, Intracranial pressure transducer in patient's head, It's been 4 hours since the last time a patient was given a painkiller, 18 years 60 years Both History of cardiovascular disease Hypertension, Infection, Epilepsy, Prior Stroke or concussion history, Endocrine disorder, Cushing, Diabetes, Liver Failure, Kidney Failure, Brain Tumor, Alcoholism, Syncope, Hearing loss, Major Fractures such as Limbs, Abdomen, Chest, Injury to the patient's ears by accident, Patient's family dissatisfaction at each stage of intervention, Narcotic Addiction, otorrhea, Severe smokers, Taking drugs that lead to anesthesia, taking corticosteroids, Drug and food poisoning Concurrent with a severe head injury, Blindness, bilateral eyelid inflammation or ptosis N/A N/A N/A First intervention group: Familiar voices were heard for thirty minutes. Which, based on the patient's family history, recorded the most intimate voice of the patient in a quiet environment. And there was no whimper or cryingwhen recording the sound.While talking to the patient several times, they called the patient by the name they were calling home and in their intimate surroundings. And the person who was recording his voice introduced himself to the patient in his own cultural language at the beginning of the recording. She told the patient what had happened to her and was admitted to the intensive care unit. And he assured the patient to keep track of his treatment and return to health. And they talked about what was going on in the last month and what they were going to do after the patient recovered. Control group: These patients were receiving routine care in the intensive care unit, and no other new work was being done in the twelve days they were monitored. The headphone was used for thirty minutes for this group of patients who did not make any noise to ensure that the outcome collector was not aware of the control group. Preferred Music group:The patient's favorite music sound was played for thirty minutes based on the patient's family history of using the headphones. The level of blood cortisol levels. Timepoint: The first morning before and after the intervention. Method of measurement: Due to the patient's rights and the high cost of this trial, it was measured twice in only one intervention.Blood sampling was performed by the same collector of outcomes in the Same way. The blood samples were immediately sent to the laboratory of Shahid Rajaee Hospital in Shiraz and put in a centrifuge. The centrifuge was set for five minutes and thirty rounds. After centrifuging the samples, the serum was removed by blood sampling. Serum samples were kept at -20 ° C until the end of the study. At the end of sampling, patients' serum samples were transferred to another laboratory due to lack of laboratory facilities at Shahid Rajaee Hospital in Shiraz. And all patient serum samples in a laboratory were measured by one person using a device with identical kits. The level of intracranial pressure. Timepoint: Before, during, and after the intervention twice daily for three days. Method of measurement: An S1800-ER monitoring device was used to measure intracerebroventricular pressure in patients with severe head trauma admitted to critical care units. It has TFT color display.Patient-related parameters were measured momentarily and updated. Intracerebral pressure was measured using a ventriculostomy implanted by a neurosurgeon within the patient's brain ventricle. Which, due to its aggressive procedure, was used only in patients who, according to their own medical needs, were diagnosed by a neurosurgeon in order to monitor intraocular pressure,The other end of the ventriculostomy was connected to the monitoring device by a transducer. The level of consciousness. Timepoint: Before, during, and after the intervention twice daily for twelve days. Method of measurement: Using the Glasgow Coma Scale, the level of consciousness of patients with severe head injury was measured. Blood pressure. Timepoint: Before, during, and after the intervention twice daily for twelve days. Method of measurement: Monitoring model S1800-ER was used to measure blood pressure in patients with severe head injury admitted to intensive care units. Heart rate. Timepoint: Before, during, and after the intervention twice daily for twelve days. Method of measurement: The S1800-ER monitoring device was used to measure heart rate in patients with severe head injury admitted to intensive care units. Temperatures. Timepoint: Before, during, and after the intervention twice daily for twelve days. Method of measurement: The S1800-ER monitoring device was used to measure the armpit temperature of patients with severe head injury in intensive care units. Mean arterial pressure. Timepoint: Before, during, and after the intervention twice daily for twelve days. Method of measurement: The S1800-ER monitoring device was used to measure mean arterial pressure in patients with severe head injury admitted in intensive care units. Cerebral perfusion pressure. Timepoint: Before, during, and after the intervention twice daily for three days. Method of measurement: We reduced the mean arterial pressure from intracranial pressure. Level of consciousness, intracranial pressure level, blood cortisol level, vital signs. Timepoint: Before, during and after the intervention twice daily for two weeks. Method of measurement: Using the Glasgow Coma Scale, intracranial blood pressure transducer, cardiovascular monitoring device, blood sampling and sending to the laboratory. Shiraz University of Medical Sciences Approved 2019-12-25 Kerman Medical Sciences Kerman, Beginning of the Axis of the Seven Gardens of Alavi, Campus of the University of Medical Sciences kerman Kerman Iran (Islamic Republic of)