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IRCT20251118068029N1 IRCT 2025-11-20 Tehran University of Medical Sciences Studying the effect of motivational spirometry and diaphragmatic breathing on arterial blood oxygen saturation. Studying the effect of motivational spirometry and diaphragmatic breathing on arterial blood oxygen saturation in patients with COVID hospitalized 2025-11-22 anticipated 80 Complete https://irct.ir/trial/87567 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The study will be conducted as a randomized clinical trial with a parallel design. Due to the nature of the intervention, it was not possible to blind participants and administrators, but the statistical analyst will be blinded. Group allocation will be done with a random number table, Randomization description: In this study, after selecting the samples using a convenience method, participants will be assigned to two intervention groups (diaphragmatic breathing and motivational spirometry) in a 1:1 ratio using a computer-generated random number table. This process will be performed without researcher intervention and according to standard randomization principles. N/A Coronavirus disease (COVID-19)Respiratory hypoxia in patients with COVID-19 (with up to 50% lung involvement and no need for invasive ventilation). Intervention 1: Control group: Diaphragmatic breathing: The patient, in a sitting or semi-sitting position, places one hand on the chest and the other on the abdomen. Deep breathing is performed through the nose so that only the hand on the abdomen rises (the chest remains fixed), then with pursed-lips and gentle pressure on the abdomen, slow exhalation is performed (exhalation time is twice the inhalation time). The intervention will be performed in three periods of 10 breaths (rate of 10 breaths per minute) with a 30-second rest between periods. Intervention 2: Intervention group: Use of an incentive spirometry device (inspiratory type, Saadat Company, calibrated): The patient, in a sitting or semi-sitting position, after a complete exhalation, places the mouthpiece of the device completely in the mouth and takes a deep and slow breath to reach the maximum inspiratory volume with visual feedback from the device. After each inhalation, the mouthpiece is removed and a slow exhalation is performed (exhalation time is twice the inhalation time). The intervention will be performed exactly the same as the first group in three periods of 10 breaths with a 30-second rest between periods. Yes - There is a plan to make this available What will be shared: The main data file includes 80 patients (40 in the diaphragmatic breathing group + 40 in the incentive spirometry group). The variables in the data are: Demographic characteristics (age, gender, education level, length of hospitalization, percentage of lung involvement, oxygen therapy method, underlying disease). Vital signs and SpO₂ at four time points (before the intervention, immediately after, 5 minutes later, 10 minutes later). Complications during the intervention (tachycardia, bradycardia, respiratory distress, decreased consciousness, etc.). Randomization code and patient group This file can also be shared, but perhaps only parts of it will be published publicly. We will probably only share the raw and more detailed data with others upon formal request and approval from the ethics committee, because participant confidentiality is a red line for us. In general, we would like our data and findings to be shared with the world, but with caution and care, to both advance science and preserve the privacy of the samples. When: Access begins 6 months after results are published. To whom: Researchers working in academic institutions and industry Conditions: Our anonymized data is a treasure trove that we can share with caution. Researchers can use this data for statistical analyses, such as comparing means or examining correlations, or use educational documentation to design similar courses. All of this will be under the supervision of an ethics committee and with a commitment to confidentiality. To request access, they must provide a formal letter stating the purpose of the research, ethical approval from a reputable institution, and a commitment not to publish the raw data so that we can safely share this information with them. Where to obtain: To Dr. Ali Karimi Rozveh, faculty member of the project, email karimi_rozveh@yahoo.com How to obtain: In order for the documents or data files to reach the applicant, there are a few simple but important steps that need to be taken. Your request is like a letter that first reaches Dr. Ali Karimi Rozveh, the study’s director; simply submit it via email or by calling the Tehran University of Medical Sciences’ School of Nursing and Midwifery. He or she will review your request, including the intended use and ethical documents, and if everything is complete, will give initial approval. This usually takes about a week. Next, the data must be anonymized; for example, student names and codes are removed to maintain privacy. This step, which is performed by the research team, takes about 5 to 7 days. Then, the Tehran University of Medical Sciences’ Ethics Committee does a final review to make sure everything is in order. this also takes another week. Finally, the files will be sent to you via email or secure drive. Overall, if your application is complete and flawless, it will take about 2 to 3 weeks for this treasure to reach you. Comments:
public Ali Karimirozveh
Dr. Mirkhani St. (East Nusrat), Tawheed Square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 karimi_rozveh@yahoo.com Tehran University of Medical Sciences scientific Ali Karimirozveh
Dr. Mirkhani St. (East Nusrat), Tawheed Square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 karimi_rozveh@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Conscious and cooperative individuals Having a definite diagnosis of COVID-19 Maximum 50% lung involvement Requiring a physician’s order for respiratory physiotherapy Systolic and diastolic blood pressure ranged 100-140 mmHg and 60-90 mmHg, respectively Heart rate range of 60-100 beats per minute 18 years no limit Both Suffering from COPD or bronchospasm (based on medical reports confirmed by a specialist) Being under the prescription of drugs that control vital signs (e.g., dopamine, dobutamine, nitroglycerin) Need of invasive ventilation B97.2 Coronavirus as the cause of diseases classified to other chapters Rehabilitation Rehabilitation Control group: Diaphragmatic breathing: The patient, in a sitting or semi-sitting position, places one hand on the chest and the other on the abdomen. Deep breathing is performed through the nose so that only the hand on the abdomen rises (the chest remains fixed), then with pursed-lips and gentle pressure on the abdomen, slow exhalation is performed (exhalation time is twice the inhalation time). The intervention will be performed in three periods of 10 breaths (rate of 10 breaths per minute) with a 30-second rest between periods. Intervention group: Use of an incentive spirometry device (inspiratory type, Saadat Company, calibrated): The patient, in a sitting or semi-sitting position, after a complete exhalation, places the mouthpiece of the device completely in the mouth and takes a deep and slow breath to reach the maximum inspiratory volume with visual feedback from the device. After each inhalation, the mouthpiece is removed and a slow exhalation is performed (exhalation time is twice the inhalation time). The intervention will be performed exactly the same as the first group in three periods of 10 breaths with a 30-second rest between periods. Changes in arterial oxygen saturation (SpO₂) measured with a calibrated pulse oximeter at four times: before the intervention, immediately after the intervention, 5 minutes after the intervention, and 10 minutes after the intervention. Timepoint: Time points for measuring the main outcome (SpO₂ and other vital signs):Before the intervention (Baseline)Immediately after the end of the intervention5 minutes after the end of the intervention10 minutes after the end of the intervention. Method of measurement: The percentage of arterial oxygen saturation (SpO₂) will be measured non-invasively from the index or middle finger of the patient's non-dominant hand using a Saadat digital pulse oximeter device that has been calibrated and validated by the hospital's medical engineers. The measurement will be performed at four time points (before the intervention, immediately after, 5 minutes after, and 10 minutes after the intervention) and under the same conditions (sitting/semi-sitting position and complete patient rest), and the values ​​will be recorded directly from the ward's central monitor and pulse oximeter. Tehran University of Medical Sciences Approved 2022-04-27 Research Ethics Committee of Tehran University of Medical Sciences - Faculty of Nursing and Midwifer Somayeh St Tehran Tehran Iran (Islamic Republic of)