Studying the effect of motivational spirometry and diaphragmatic breathing on arterial blood oxygen saturation in patients with COVID hospitalized

compare the effect of diaphragmatic breathing and motivational spirometry on blood oxygen saturation (SpO₂) in patients with COVID-19.

An open-label, parallel, randomized clinical trial with 2 active intervention groups will be conducted on 80 COVID-19 patients at Sina Hospital, Tehran. The sample size will be calculated based on a previous study and allocated at a 1:1 ratio; the study will not have a clinical phase.

This study will be conducted in the COVID-19 ward of Sina Hospital, Tehran. 80 conscious COVID-19 patients will be divided into two groups of 40 and will receive a respiratory intervention session consisting of 3 sets of 10 breaths with 30 seconds of rest. SpO₂ and vital signs will be measured before, immediately, 5 and 10 minutes after the intervention. The study was open-label and only the statistical analyst will be blinded.

Inclusion criteria: COVID-19 patients with a confirmed diagnosis, conscious and cooperative, ≤50% lung involvement, physician prescription for respiratory physiotherapy, normal blood pressure and heart rate, no COPD/bronchospasm, no medications affecting vitals, and no need for invasive ventilation. Exclusion criteria: Instability of vital signs or level of consciousness, occurrence of complications during the intervention, or patient unwillingness to continue cooperation.

Diaphragmatic breathing group: Deep breathing focusing on diaphragm movement Incentive spirometry group: Using an incentive spirometer with deep, slow breathing to achieve maximum inspiratory volume, then slow exhalation

SpO₂ changes at four time points: baseline, immediately, 5 and 10 minutes after intervention; analysis with repeated measures ANOVA and Greenhouse-Geisser correction in both groups.

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.

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.

Access begins 6 months after results are published.

Researchers working in academic institutions and industry

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.

To Dr. Ali Karimi Rozveh, faculty member of the project, email karimi_rozveh@yahoo.com

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.