The effect of preoperative incentive spirometry (IS) on postoperative pain intensity, respiratory parameters, and quality of recovery in patients undergoing Coronary Artery Bypass Graft

Determining the effect of preoperative incentive spirometry (IS) on postoperative pain intensity, respiratory parameters, and quality of recovery in patients undergoing Coronary Artery Bypass Graft

Randomized clinical trial with parallel control group, double-blind, on 100 patients and randomization by permutation block method and random allocation method.

The place of research will be in open heart intensive care unit and heart surgery unit in 3 Mashhad hospitals. The procedure is as follows: after explaining the purpose and procedure to the patients, and if they have the conditions to enter the study, they are placed in 3 groups according to the EF of their heart. Then, in each group, according to the permutation block method and randomized allocation, each patient is placed in the intervention or control group. After the surgery, the patients of both groups will be monitored for 3 days and the required data will be obtained from them. During these 3 days, they will receive the same interventions and care. Double blinding is also done according to what was explained earlier.

The conditions for entering the study include informed consent, age between 18 and 70 years, stable hemodynamics, and type of off-pump surgery. Exclusion criteria: non-satisfaction; use of CPB pump; severe complications such as CVA; patient death.

Volumetric incentive spirometry is used 2 days before surgery in the intervention group. In every hour of the patient's wakefulness, he should breathe 10 times and practice with spirometry (the principles of which will be taught to the patient). In the control group, routine interventions after surgery, such as incentive spirometry, etc., are implemented.

Pain intensity; respiratory parameters; quality of recovery

Patients will be classified according to their EF level (according to what was explained in the sampling method) into 3 categories (equal to or more than 50%, between 40 and 50% and equal to or less than 40%). became. Then they will be divided into intervention and control groups using permutation blocks and random allocation method. The volume of each block will be 4 people. First, all the possible permutations were written for 4 people with 2 occurrences A (intervention) and B (control), which consisted of 6 different states. Each of them was given a code from 1 to 6. Now, each number from 1 to 6 was written on a sheet of equal size and selected one by one by lottery (for example, 3, 4, 1, 5, 2, and 6). According to the states written for each of these numbers, and the specified codes, we write their results. This random process for choosing between intervention or control for all patients of each group will continue until the selection of the last individual of the desired sample size.

This study is single blind. Patients who meet the necessary conditions to enter the study, after explaining about the method and purpose of the research and completing the written informed consent, enter the study. But they do not know whether they are in the control group or in the intervention group (they only know that they entered a research project with a specific goal). In this way, patients will be blinded. This blinding will reduce the bias error and increase the validity of the study.

After the completion of the study and conclusions by the research team, with the consent of the source university, namely Sabzevar University of Medical Sciences and the hospitals where the data were collected, the results of this study will be made available.

The access period will start 6 months after the results are published.

All people working in the field of medical sciences, especially nurses and doctors, including students, professors and clinical personnel (university and non-university) can access the results.

If you want to use the data, please contact me, Hamid Saboorifar.

You can communicate in the following ways: 1. Visit in person to Imam Zaman Hospital, Cardiology Department 2. Phone number: 00989156513677 3. Email: hmydsbwryfr@gmail.com

After announcing your request, this matter will be discussed with other colleagues who have a role in this research (including the honorable supervisor and the honorable professors of the consultant) and if they approve, the information you need will be sent as soon as possible.

Thank you for advancing scientific and research goals