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IRCT20210406050871N1 IRCT 2021-04-25 Shahroud University of Medical Sciences The effect of percutaneous electrical nerve stimulation on the respiratory outcomes of patients with Covid-19 with moderate pulmonary involvement The effect of percutaneous electrical nerve stimulation on the respiratory outcomes of patients with Covid-19 with moderate pulmonary involvement: A clinical trial 2021-04-30 anticipated 84 Complete https://irct.ir/trial/55531 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The 4-block block randomization method is used to create a random allocation sequence in this study because the participants gradually enter the study and also the number of assignments to each group is equal. In this research, the random allocation sequence is obtained by the methodology consultant with the software. After creating a random sequence, 84 opaque envelopes with wrappers are prepared and each random sequence is recorded on a card and placed inside the envelopes and closed. In order to maintain the sequence and to prevent disruption, the envelopes will be numbered and placed in a box. Eligible participants will be registered by the principal investigator in the order of their arrival, and an envelope will be opened in the order in which the person enters the study, one of the envelopes will be opened, and thus his / her assigned group will be revealed. Individuals will be placed equally in each group, Blinding description: The present study is three-blind and in addition to the participants, the data collector (outcome assessor) and the statistical analyst are not aware of the allocation of groups. The data collector who is involved in collecting and recording information such as respiration rate, pulse, oxygen saturation, etc., or in completing questionnaires will be unaware of the group of individuals. The analyst will also be unaware of the group of people. It should be noted that the physiotherapist who is responsible for the intervention and is known as the caregiver, by contacting the research colleague who has the sequence, becomes aware of the group to which each person is assigned and performs the intervention. N/A Covid-19. Intervention 1: Intervention group: is performed by a researcher who does not know the assignment of groups under the supervision of an Acu-TENS trained physiotherapist for the intervention group in such a way that the patient is in a sitting or semi-sitting position and by re-controlling the skin of the area for lesions, Two plastic electrodes 5 × 5 cm and sticky are placed on both sides of the spine appendage of 7 cervical vertebrae; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes. Intervention 2: Control group: by a researcher who does not know the assignment of groups under the supervision of a trained physiotherapist, ineffective Acu-TENS was performed for the control group in such a way that the patient is placed in a sitting or semi-sitting position and by re-controlling, the skin of in view of the lesion, two plastic electrodes of 5* 5 cm and adhesive are placed in an ineffective point for breathing, the front of the chest; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome, can be shared. When: Access period starts 6 months after the results are published To whom: Only for researchers working in academic and scientific institutions Conditions: If necessary, contact Dr. Mahboobeh Khajeh and if there is a reasonable justification for use in scientific purposes Where to obtain: Dr. Mahboobeh Khajeh Shahroud, 7thTir Square, Shahroud University of Medical Sciences; School of Nursing and Midwifery 02332395054 m_khajeh@ymail.com How to obtain: By phone call or by email and registration of the request and stating the reason and purpose of the logical and approved up to two weeks Comments:
public Mahboobeh Khajeh
7th Tir Square. Shahroud University of Medical Sciences
شاهرود Iran (Islamic Republic of) ۳۶۱۴۷-۷۳۹۴۷ +98 23 3239 5054 m_khajeh@ymail.com Shahroud University of Medical Sciences scientific Mahboobeh Khajeh
7th Tir Square. Shahroud University of Medical Sciences
شاهرود Iran (Islamic Republic of) ۳۶۱۴۷-۷۳۹۴۷ +98 23 3239 5054 m_khajeh@ymail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Confirmation of Covid-19 diagnosis based on PCR test results or CT Scan findings (Ground Glass view) by physician Age over 18 and under 70 years Use the same treatment protocol for patients Existence of moderate pulmonary involvement (SpO2 between 90 to 93% and pulmonary involvement less than 50%) and the patient being in the second phase of Covid-19 disease according to the guideline of the Ministry of Health 18 years 70 years Both Drug addiction Cigarette addiction Advanced metastatic cancer Congestive heart failure (grades 3 and 4) Kidney failure requires dialysis History of mechanical ventilation before intervention Existence of cardiac pacemaker Cardiac conduction disorders History of allergies and skin sensitivities in the area of ​​the electrodes The presence of a skin lesion in the area where the electrodes are placed Hospitalized patients with other clinical manifestations of Covid-19 and no pulmonary involvement Continuous use of bronchodilators Having liver failure Moderate to severe scoliosis Obesity (BMI above 35) Psychological illnesses lead to lack of patient cooperation Cerebrovascular disorders Having COPD Having uncontrolled diabetes Inability and prohibition to be in a semi-sitting position for any reason U07.1 Coronavirus disease (COVID-19) Treatment - Devices Treatment - Devices Intervention group: is performed by a researcher who does not know the assignment of groups under the supervision of an Acu-TENS trained physiotherapist for the intervention group in such a way that the patient is in a sitting or semi-sitting position and by re-controlling the skin of the area for lesions, Two plastic electrodes 5 × 5 cm and sticky are placed on both sides of the spine appendage of 7 cervical vertebrae; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes. Control group: by a researcher who does not know the assignment of groups under the supervision of a trained physiotherapist, ineffective Acu-TENS was performed for the control group in such a way that the patient is placed in a sitting or semi-sitting position and by re-controlling, the skin of in view of the lesion, two plastic electrodes of 5* 5 cm and adhesive are placed in an ineffective point for breathing, the front of the chest; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes. Percentage of arterial blood oxygen saturation. Timepoint: Daily for up to 4 days before and after the intervention. Method of measurement: Finger pulse oximeter device and monitor. Need for mechanical ventilation. Timepoint: 4, 8 and 12 days after the intervention. Method of measurement: Checklist. Death and survival. Timepoint: until the end of hospitalization. Method of measurement: Checklist. Vital signs (RR,HR). Timepoint: Daily for up to 4 days before and after the intervention. Method of measurement: Count the respiratory rate and heart rate in a minute and record them in a checklist. Severity of breathing (Dyspnea). Timepoint: Daily for up to 4 days before and after the intervention. Method of measurement: Visual Analogue scale for dyspnea (VASD). Shahroud University of Medical Sciences Approved 2021-04-11 Ethics Committee of Shahroud University of Medical Sciences 7th Tir Square, Shahroud University of Medical Sciences Shahroud Semnan Iran (Islamic Republic of)