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IRCT20220924056030N1 IRCT 2022-11-18 Alborz University of Medical Sciences Investigating the effect of sound on reducing the anxiety level of patients The effect of familiar voice on the patient and the use of sedatives in patients with mechanicalventilation in the ICU trauma wards of the Madani hospital 2023-01-21 anticipated 99 Complete https://irct.ir/trial/66026 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: non, Randomization description: For the purpose of random allocation, the method of dividing blocks of six is used. In this way, two test groups of letter A and B were assigned a control group of letter C,And in blocks of six with letters A, B, and C, ninety states such as ABABCC, AABBCC were written on sheets and thrown into a containerRandomly one of these sheets was taken out of the container and the composition written on it was written down and that sheet was placed outside the container, The sample size in this study was estimated to be 99 patients; Therefore, this process was repeated 17 times (102 x 6 = 17) and each time the extracted combination was written on the sheet following the previous combination. Then, each letter from the beginning of the blocks was assigned a number from 1 to 102.Then the letter was put inside the envelope and the number of that letter was written on the envelope. Each time a patient was admitted, one of the envelopes was opened in the order of the numbers written on the envelope, and it was determined whether the patient should be in the test group or the control group, Blinding description: The person performing the intervention for the patient as well as the person recording the patient's information are blinded to which study patient is in which study group (intervention 1 or 2 and control). N/A head injury. Intervention 1: Intervention group: A group that receives a familiar voice,First-degree relatives are asked who had a stronger emotional relationship with the patient, then the person who had a stronger emotional relationship according to the patient's relatives is asked to repeat the message written by the researcher and their voice is recorded. Yes, this sound is played twice a day for 15 to 30 minutes. Intervention 2: Intervention group: The second group is the group that receives the nurse's voice so that the nurse repeats the message that the researcher says and this message is recorded, the recorded message every day and every time for 15 to 30 minutes during two weeks. It is distributed to patients. Intervention 3: Control group: Patients in the control group have headphones placed on their ears for 15-30 minutes, but no sound is played for them (putting headphones without sound on the ears to reduce the volume of sounds and not hear false sounds by the patient). Yes - There is a plan to make this available What will be shared: Information related to the main design variables will be disclosed When: Since the termination of the plan To whom: All people and applicants Conditions: In the form of an article Where to obtain: To the email of the author responsible for the plan How to obtain: Just sending an email to the author responsible for the project is enough Comments:
public Zahra Tayebi Myaneh
Baghestan Blvd. Nursing School
Karaj Iran (Islamic Republic of) 314683811 +98 26 3433 6007 Nursing@abzums.ac.ir Karaj University of Medical Sciences scientific Zahra Tayebi
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Karaj Iran (Islamic Republic of) 3146883811 +98 912 882 2421 Tayebi.medical@gmail.com Alborz University of Medical Sciences Iran (Islamic Republic of) The age of the patient is 18 to 65 years The level of consciousness should be 8 to 11 according to the Glasgow Trauma Coma Scale, and 10 to 16 according to the Faure Scale. The patient has been admitted to the ward with a diagnosis of concussion. Concussion includes subdural, epidural, intracerebral, ventricular, and subarachnoid hemorrhages. Sedation should be in the range of +2 to -2 based on the Richmond criteria. 48 hours have passed since hospitalization According to the opinion of the attending physician or ENT consultation, patients should have healthy hearing on at least one side. Don't have bandages in their ears No history of depression and other mental disorders Family availability and cooperation for audio recording Not using tobacco, alcohol and highly addictive drugs before the accident according to the family's statement 18 years 65 years Both Having an underlying disease Have a previous history of hearing loss according to family statements Any illness except head injury - - Other Other Other Intervention group: A group that receives a familiar voice,First-degree relatives are asked who had a stronger emotional relationship with the patient, then the person who had a stronger emotional relationship according to the patient's relatives is asked to repeat the message written by the researcher and their voice is recorded. Yes, this sound is played twice a day for 15 to 30 minutes. Intervention group: The second group is the group that receives the nurse's voice so that the nurse repeats the message that the researcher says and this message is recorded, the recorded message every day and every time for 15 to 30 minutes during two weeks. It is distributed to patients. Control group: Patients in the control group have headphones placed on their ears for 15-30 minutes, but no sound is played for them (putting headphones without sound on the ears to reduce the volume of sounds and not hear false sounds by the patient) The level of anxiety: an emotional state that is associated with a feeling of tension, anger, changes in vital signs and increased need for oxygen and increased mortality in patients.س. Timepoint: After the audio is played, it is recorded daily. Method of measurement: Anxiety facial scale. Dosage of drugs taken in mg during the day of hospitalization. Timepoint: Daily. Method of measurement: According to the amount of daily prescription and the amount of medicine received through case review and nursing report. The type of sedative drugs, which are divided into 4 categories: barbiturates, benzodiazepines, and narcotics. Timepoint: Daily. Method of measurement: According to the order prescribed through the patient file and nursing report. Duration of taking sedatives. Timepoint: Daily. Method of measurement: Daily. Mechanical ventilation status. Timepoint: Daily. Method of measurement: View and insert in the checklist. Alborz University of Medical Sciences Approved 2022-09-18 Ethics Committee of Alborz University of Medical Sciences Alborz Nursing School, Golestan 1st, Golestan 1st, Sobhamati St., Baghistan, Karaj Karaj Alborz Iran (Islamic Republic of)