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IRCT20160716028948N2 IRCT 2021-12-29 Ghoum University of Medical Sciences Effect of breathing exercises training in arterial oxygen saturation and anxiety of COVID-19 Patients Effect of breathing exercises training on arterial oxygen saturation and anxiety in COVID-19 Patients 2021-12-31 anticipated 70 Complete https://irct.ir/trial/60686 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: By referring to the Medical Record Unit of Qom educational hospital, the files of hospitalized COVID-19 patients will be extracted and samples will be selected by simple random sampling (using lottery) based on inclusion criteria. Then, each person is given a number and based on random numbers table, the subjects will be placed in two groups of control and intervention. In this way, from the table, the two digits on the left side of the number chosen randomly are considered as the number of the person and and patients will be placed in two groups of control and intervention every others. N/A COVID-19. Intervention 1: Intervention group: After completing the written consent by the patients, information is collected from the samples of the intervention and control groups by the Beck Anxiety Inventory and a checklist of clinical data on O2Sat and respiration rate. Then, the training program of breathing exercises runs according to the protocol of breathing exercises and relaxation for the intervention group, during 15-minute daily sessions for four weeks at home and virtually (internal messengers such as Eitaa) through the training content provided by trained experts. The subjects in these sessions receive active coughing exercises (3 sets, 10 repetitions), diaphragmatic breathing and budding lips (30 voluntary breathing in various positions including supine position, prone position, side-lying position, and quadruped position), chest volume-enhancing exercises according to the therapist's instructions (the patient performs horizontal opening, bending, turning and external rotation of the arms at the same time with each breathing cycle) and resistance exercises of the respiratory muscles by the patient himself. These exercises will be in a range of simple to difficult and based on the patient's condition. Also, during these four weeks, the research team will be sure that the intervention protocol movements are performed correctly by the patients. One week after the intervention, the level of anxiety and O2Sat in the hospital will be measured again using a pulse oximetry device and a questionnaire by the same researcher who measured and recorded the outcome variables before the breathing exercises. Intervention 2: Control group: No educational intervention is done on the control group and they are received only usual care. Also, data are collected from the samples of the control group before and one week after the intervention. 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 Decisions should be made at the university's discretion
public Dr Zahra Taheri-kharameh
Iran, Qom, University Campus, Building No. 1, School of Paramedical Sciences
Qom Iran (Islamic Republic of) 373617-5513 +98 25 3197 1136 ztaheri@muq.ac.ir Ghoum University of Medical Sciences scientific Dr Zahra Taheri-kharameh
Iran, Qom, University Campus, Building No. 1, School of Paramedical Sciences
Qom Iran (Islamic Republic of) 37361-75513 +98 25 3197 1136 ztaheri@muq.ac.ir Ghoum University of Medical Sciences Iran (Islamic Republic of) Having a minimum Hemoglobin 11 gr/dl Having body temperature between 36.5°C to 37.5°C Having minimum systolic blood pressure 100 mmHg Going through the acute stage of the disease Having full consciousness and awareness of time, place and person Having the desire to participate in training Have not previously received any training on breathing exercises and have not participated in any other training program during this study. 20 years 75 years Both Having heart, kidney, liver, gastrointestinal, and peripheral edema problems Having uncontrolled diabetes and blood pressure Exacerbation of the disease and death of the patient during the study U07.1 COVID-19,virus identified Rehabilitation N/A Intervention group: After completing the written consent by the patients, information is collected from the samples of the intervention and control groups by the Beck Anxiety Inventory and a checklist of clinical data on O2Sat and respiration rate. Then, the training program of breathing exercises runs according to the protocol of breathing exercises and relaxation for the intervention group, during 15-minute daily sessions for four weeks at home and virtually (internal messengers such as Eitaa) through the training content provided by trained experts. The subjects in these sessions receive active coughing exercises (3 sets, 10 repetitions), diaphragmatic breathing and budding lips (30 voluntary breathing in various positions including supine position, prone position, side-lying position, and quadruped position), chest volume-enhancing exercises according to the therapist's instructions (the patient performs horizontal opening, bending, turning and external rotation of the arms at the same time with each breathing cycle) and resistance exercises of the respiratory muscles by the patient himself. These exercises will be in a range of simple to difficult and based on the patient's condition. Also, during these four weeks, the research team will be sure that the intervention protocol movements are performed correctly by the patients. One week after the intervention, the level of anxiety and O2Sat in the hospital will be measured again using a pulse oximetry device and a questionnaire by the same researcher who measured and recorded the outcome variables before the breathing exercises. Control group: No educational intervention is done on the control group and they are received only usual care. Also, data are collected from the samples of the control group before and one week after the intervention. Arterial blood oxygen saturation (O2Sat). Timepoint: The effect of breathing exercises training on Arterial blood oxygen saturation (O2Sat) in Covid-19 patients, before and one week after the intervention. Method of measurement: Arterial blood oxygen saturation (O2Sat) checklist. Respiratory rate (RR). Timepoint: The effect of breathing exercises training on respiratory rate in Covid-19 patients, before and one week after the intervention. Method of measurement: Respiration rate checklist. Anxiety. Timepoint: Before and one week after the intervention. Method of measurement: Beck Anxiety Inventory. Ghoum University of Medical Sciences Approved 2021-07-14 Ethics Committee Qom University of Medical Sciences No. 83, alley 4, Jahad daneshgahi street, Safashahr street, Qom, Iran Qom Ghoum Iran (Islamic Republic of)