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IRCT20240103060598N1 IRCT 2024-04-04 Bagheiat-allah University of Medical Sciences The Effect of Guided visualization on Calming and Improving the Blood Oxygen Level of Chronic Obstructive Pulmonary Disease Patients Under Non-invasive Mechanical Ventilation The Effect of Guided visualization on Calming and Improving the Blood Oxygen Level of Chronic Obstructive Pulmonary Disease Patients Under Non-invasive Mechanical Ventilation 2024-01-21 anticipated 27 Complete https://irct.ir/trial/74852 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using Altman's nomogram, the required sample size of 27 people in each group was estimated, which was studied by considering ten percent dropout of 30 people in each group. The initial screening was done based on the entry and exit criteria, 70 people were selected and then from Numbers 1 to 70 are coded and sixty patients are selected by lottery and again these sixty patients are listed from number one to sixty using a table of random numbers. N/A Congestive respiratory diseases. Intervention 1: Intervention group:The intervention group used an audio file with headphones based on Benson's relaxation technique for 30 minutes while using a non-invasive mask and repeated up to one hour if needed and controlling the level of anxiety with the rass criterion as well as controlling the physiological conditions such as heart rate, blood pressure of the patient before And after the audio file. Intervention 2: Control group: The control group uses a non-invasive mask alone, as per the department's protocol, and before and during the use of the mask, the blood oxygen level, vital signs and anxiety level of the patient will be controlled with rass criteria. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Javad Jamalreza
Pirouzi Blvd., 20 Alizadeh Haft, No. 14, Unit 1
Mashhad Iran (Islamic Republic of) 9177974865 +98 915 935 8173 javadjjamalreza@gmail.com Bagheiat-allah University of Medical Sciences scientific Abolfazl Rahimi
Baqiyatullah University, Sheikh Bahai St., Mulla Sadra St., Vanak Square, Tehran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 5256 fazel123@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Having COPD Needs high pressure oxygen therapy- Patients with mechanical ventilation with a non-invasive mask- Age between 15 and 65 years old Having healthy hearing and full consciousness Not having nervous and mental diseases- Not taking sedatives and sleeping pills 15 years 65 years Both Invasive mechanical ventilation Repentance or decreased level of consciousness of the patient during the study Use of sedative drugs Unwillingness to continue research J44 Other chronic obstructive pulmonary disease Other Other Intervention group:The intervention group used an audio file with headphones based on Benson's relaxation technique for 30 minutes while using a non-invasive mask and repeated up to one hour if needed and controlling the level of anxiety with the rass criterion as well as controlling the physiological conditions such as heart rate, blood pressure of the patient before And after the audio file Control group: The control group uses a non-invasive mask alone, as per the department's protocol, and before and during the use of the mask, the blood oxygen level, vital signs and anxiety level of the patient will be controlled with rass criteria Reducing the anxiety of patients undergoing non-invasive ventilation. Timepoint: Restlessness level control - physiological conditions when using a non-invasive mask before listening to the file and half an hour after listening to the file. Method of measurement: Use of rass criteria - pulse oximeter and pressure gauge. Bagheiat-allah University of Medical Sciences Approved 2023-12-11 Baqiyatullah-ul-Azam (A.J.) Medical Education Center (Ethics in Research Committee) Tehran - Quds town (west) - between South Flamak and Zarafshan, Simai Iran St. - Central Headquarters of Ministry of Health, Treatment and Medical Education, Block A, 13th floor tehran Tehran Iran (Islamic Republic of)