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IRCT20201012049010N1 IRCT 2020-11-12 Qazvin University of Medical Sciences The effect of balloon-blowing on dyspnea and oxygenation in non-critical adult covid-19 patients. A pilot study of the evaluating of the effectiveness of balloon-blowing on dyspnea and oxygenation in non-critical adult covid-19 patients: a randomized clinical trial. 2020-07-22 anticipated 90 Complete https://irct.ir/trial/51591 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Participants in the study were divided into two groups based on, blocks of 10, designed by Excel software in the form of random numbers, Blinding description: The collected data of the two groups were statistically analyzed without labels. N/A dyspnea and hypoxia in COVID-19. Intervention 1: Control group: They received all the necessary medication based on the decision of the relevant medical team. Intervention 2: Intervention group: They received all the necessary medication based on the diagnosis of the relevant medical team (Same with the control group) ; And also the patients were asked, after receiving adequate information and training about the procedure, to inflate a balloon, by blowing up and empty it at least 5 times a day and for a minimum 5 times each time, while lying on the bed. In case of insufficient power to inflate the balloon, the balloon was substituted with a latex glove. The balloons and/or latex gloves were replaced daily. Yes - There is a plan to make this available What will be shared: All collected data will be available after publication in the relevant journal. When: Immediately after the publication of the article. To whom: All medical researchers and institutes. Conditions: All data will be provided to applicants by mentioning the source and the study performed. Where to obtain: Receiving the collected data can be done by email or phone call with the original designer of the project. How to obtain: The data will be provided, after checking the eligibility of the applicant, immediately. Comments:
public Mohammad Bargahi
No-20, Jahangir Ebrahim Ave, Jeyhoon St, tehran.
Tehran Iran (Islamic Republic of) ۱۳۴۳۹۶۳۷۸۵ +98 21 6601 6580 mmd.bargahi@gmail.com Qazvin University of Medical Sciences scientific Mohammad Bargahi
No-20, Jahangir Ebrahim Ave, Jeyhoon St, tehran.
Tehran Iran (Islamic Republic of) ۱۳۴۳۹۶۳۷۸۵ +98 21 6601 6580 mmd.bargahi@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) ≥ 18 years old Patients with definitive diagnosis of Covid-19 Hospitalization in non-intensive care unit dyspnea according to the patient O2-saturation <93% recorded by a pulse oximeter. 18 years no limit Both History of lung diseases (under treatment) History of kidney diseases (under treatment) History of heart diseases history of allergy to latex or balloon material Any case of prohibition from Intense aerobic activity by a physician the need for hospitalization in intensive care units(ICU or CCU). Pregnancy History of neurological diseases U07.1+R06. تنگس نفس-هیپوکسی-کووید۱۹-پنومونی های وایرال N/A Treatment - Other Control group: They received all the necessary medication based on the decision of the relevant medical team. Intervention group: They received all the necessary medication based on the diagnosis of the relevant medical team (Same with the control group) ; And also the patients were asked, after receiving adequate information and training about the procedure, to inflate a balloon, by blowing up and empty it at least 5 times a day and for a minimum 5 times each time, while lying on the bed. In case of insufficient power to inflate the balloon, the balloon was substituted with a latex glove. The balloons and/or latex gloves were replaced daily. Intensity of dyspnea at rest. Timepoint: At the beginning of the study (before the intervention) and on days 1 and 2 after the intervention. Method of measurement: Based on Borg Modified Scale. Intensity of dyspnea after 50 meters of walking with pulse oximeter. Timepoint: At the beginning of the study (before the intervention) and on days 1 and 2 after the intervention. Method of measurement: Based on Borg Modified Scale. Oxygen saturation of arterial blood without oxygen therapy. Timepoint: At the beginning of the study (before the intervention) and on days 1 and 2 after the intervention. Method of measurement: After 5 minutes of separation from the oxygen mask by the same pulse oximeter. Arterial blood oxygen saturation with oxygen therapy. Timepoint: At the beginning of the study (before the intervention) and on days 1 and 2 after the intervention. Method of measurement: In the case of oxygen therapy, by the same pulse oximeter. Gender. Timepoint: Upon entering the study. Method of measurement: Based on identity information. ‌Body mass index. Timepoint: Upon entering the study. Method of measurement: Patient weight (Kg) divided by patient height to the power of 2 (m). Age. Timepoint: Upon entering the study. Method of measurement: Based on identity information. Extent of pulmonary involvement. Timepoint: Upon entering the study. Method of measurement: Based on a CT scan report. Qazvin University of Medical Sciences Approved 2020-05-20 Ethics and Research Committee of Qazvin University of Medical Sciences Dept. of research, Qazvin University of Medical, Mavedat Ave., Shahid Beheshti Blv.,Qazvin, Iran. Qazvin Qazvin Iran (Islamic Republic of)