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IRCT20201014049029N1 IRCT 2020-11-18 Qazvin University of Medical Sciences Comparing The effect of family members' voice and nurse' voice on restlessness, anxiety, delirium and success in weaning of ventilator in patients admitted to Intensive Care Units Comparing The effect of family members' voice and nurse' voice on restlessness, anxiety, delirium and success in weaning of ventilator in patients admitted to Intensive Care Units 2020-08-22 anticipated 90 Complete https://irct.ir/trial/51690 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: All patients who meet the inclusion criteria will be included in the study by random sampling method of block division method with triple blocks. In this way, the letter A will be assigned to the test group and the letter B to the control group, and in 6 blocks with the letter A, B, C, six states ACB, ABC, CAB, BCA, BAC, CBA will be written on the sheet. The blocks will then be sorted according to a table of random numbers. N/A Head trauma. Intervention 1: Intervention group: the voice of a family member is recorded and played to patients through a headset. This intervention is performed twice a day for six days for patients. In the intervention group, this sound will be heard by patients with 60 to 80 beats per minute with MP3 PLAYER through headphones. Intervention 2: Intervention group: a nurse's voice is recorded and played to patients through a headset. This intervention is performed twice a day for six days for patients. In the intervention group, this sound will be heard by patients with 60 to 80 beats per minute with MP3 PLAYER through headphones. Intervention 3: Control group: No sound is played in this group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Fariba Abdollahi
Qazvin University of Medical Sciences Shahid Beheshti, Ave' 3415613911 Qazvin' IRAN
Qazvin Iran (Islamic Republic of) 13911/34156 +98 28 3333 7006 FaribaAbdollahi93@gmail.com Qazvin University of Medical Sciences scientific Fariba Abdollahi
Shahid Beheshti, Ave' 3415613911 Qazvin' IRAN
Qazvin Iran (Islamic Republic of) 13911/34156 +98 28 3337 5518 FaribaAbdollahi93@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) 1.The age of patients should be between 18-65 years 2.The level of consciousness according to the Glasgow coma criterion due to trauma should be 11-8 3.The patient has been admitted to the ward with a diagnosis of concussion. Traumatic brain injury includes subdural, epidural, intracerebral, ventricular, and subarachnoid hemorrhages. 4.Sedation should be in the range of +2 to 2- according to Richmond criteria 5.48 hours have elapsed since hospitalization 6.Patients should have at least one healthy hearing position according to the physician or ENT consultation 7.Have no previous history of hearing loss according to family statements 8.Do not have a bandage on the ear 9.No history of depression and other mental disorders 10.Family availability and collaboration to record audio 11.Do not use alcohol and drugs with high dependence before the accident according to family statements 18 years 65 years Both 1.Dissatisfaction of the patient's companions to continue participating in the study 2.A history of hearing, vision, aphasia and limb movement disorders 3.Patients with vegetative status as determined by physician 4.Patients with severe previous head injury 5.Sudden loss of consciousness more than 3 points according to the Glasgow Coma Criterion during the intervention 6.Simultaneous participation of the patient in similar care programs such as massage therapy and the use of relaxation techniques and ... S07.8XXS Crushing injury of other parts of head, sequela Other Other Other Intervention group: the voice of a family member is recorded and played to patients through a headset. This intervention is performed twice a day for six days for patients. In the intervention group, this sound will be heard by patients with 60 to 80 beats per minute with MP3 PLAYER through headphones. Intervention group: a nurse's voice is recorded and played to patients through a headset. This intervention is performed twice a day for six days for patients. In the intervention group, this sound will be heard by patients with 60 to 80 beats per minute with MP3 PLAYER through headphones. Control group: No sound is played in this group. Restlessness was assessed by the Richmond Restlessness Checklist. The Richmond tool consists of 10 levels, four of which are for restlessness, one for calm and alert, and five for relaxation. Timepoint: Before and after the intervention. Method of measurement: Richmond Restlessness Checklist. Delirium is assessed with the Neecham Delirium instrument and this questionnaire has a total of 30 points. Based on the overall score obtained by the patient, it is divided into 4 categories; A healthy person with a score of 27-30, prone to confusion with a score of 25-26, mild delirium with a score of 20-24, moderate to severe delirium with a score of 0-19. Timepoint: Before and after the intervention. Method of measurement: Neecham Delirium questionnaire. Anxiety was assessed with the Facial Anxiety Scale. It has a range from 1 to 5, the lowest of which is related to the normal state of the facial state and the highest of which is the number 5 related to the maximum state of anxiety. Timepoint: Before and after the intervention. Method of measurement: Facial Anxiety Scale. Weaning success was assessed with the Burn weaning Success Tool. The total score is 26 and after receiving a score of 17 or higher, the separation process begins. Timepoint: Before and after the intervention. Method of measurement: Burn weaning Success Tool. Qazvin University of Medical Sciences Approved 2020-03-02 Dept of research Qazvin University of Medical Sciences Dept of research Qazvin University of Medical Sciences Shahid Beheshti, Ave' 3415613911 Qazvin' IRAN qazvin Qazvin Iran (Islamic Republic of)