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IRCT20230223057511N1 IRCT 2023-05-08 Mazandaran University of Medical Sciences Investigating the effect of incentive spirometry and deep breathing exercise on sleeve surgery Comparison of the effect of incentive spirometry and deep breathing exercise on hemodynamic indicators and pulmonary complications during and after sleeve surgery. 2023-02-20 anticipated 75 Complete https://irct.ir/trial/68853 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: For this research, before the start of the study, after obtaining informed consent before the operation, the patients are referred continuously and available, and with the block randomization method, they are divided into three groups: incentive spirometry (I), deep breathing exercise (D), and control. (C) or routine will be assigned. The blocks of this study are 6 (II, DD, CC) which will create 27 states, first determine the possible states of these 6 letters inside the blocks and then randomly Simple and by using random numbers table number 17, the number of blocks that will complete the number of samples will be determined (1 - 27), in this way the type of intervention is determined based on the desired letters with the number of each patient and in a master sheet will be kept and the continuous entry number of the patients will be written on the envelope, and the type of intervention or control will be specified inside the envelope. Gradually, according to the presence of eligible patients, the relevant envelope is returned and the type of intervention inside the non-transparent envelope is determined and the desired technique is performed. N/A Sleeve surgery patients. Intervention 1: Intervention group: in the first intervention group, the intervention method is incentive spirometry. In this method, patients are placed in a sitting or semi-sitting position, and an incentive spirometry tube is placed in their mouth. They inhale and then hold their breath for 3-5 seconds and slowly exhale through the mouth as they remove the device. The patient performs this exercise 5 times two hours before the operation, two, six and ten hours after the operation. The average maximum inspiratory volume of the patient is recorded by incentive spirometry. Intervention 2: Control group: in the control group, only routine cares will be done. Usual hospital cares include : drug treatment, checking vital signs, controlling patients' pain and encouraging patients to breathe deeply. Intervention 3: Intervention group: the second intervention group, the intervention method is deep breathing exercise. In this method, the patient is sitting or semi-sitting, taking slow and deep breaths through the nose, at the same time, he presses the upper part of the abdomen with a pillow to reduce the pain. The patient inhales and then holds his breath for 3 to 5 seconds and exhales through pursed lips by squeezing the abdominal muscles. The patient performs this exercise 5 times two hours before the operation and two, six and ten hours after the operation. Yes - There is a plan to make this available What will be shared: Individual data of study participants is considered and all data can be shared after de-identification of individuals. When: The access period starts 6 months after publication of results To whom: Our data will only be available to researchers working in academic and scientific institutions Conditions: Our data will only be available to researchers working in academic and scientific institutions. Statistical analysis is possible on the data and they can use email to send requests. Where to obtain: Applicants can contact Fereshte Farzanmehr at the following address: Email: Fereshteh.Farzanmehr@gmail.com Postal code: 1468613831 Phone: 09128347148 How to obtain: After receiving the request by the researcher, the documents will reach the applicant within two weeks at most. Comments:
public Fereshteh Farzanmehr
Num. 136 , Second Floor, C1 Building, Sarvestan Residential Complex, Western Arghavan St.,Dadman Blvd, Sana't Squ., Tehran
Tehran Iran (Islamic Republic of) 1468613831 +98 21 2208 6052 Fereshteh.Farzanmehr@gmail.com Mazandaran University of Medical Sciences scientific Fereshteh Farzanmehr
Num. 136 , Second Floor, C1 Building, Sarvestan Residential Complex, Western Arghavan St.,Dadman Blvd, Sana't Squ., Tehran
Tehran Iran (Islamic Republic of) 1468613831 +98 21 2208 6052 Fereshteh.Farzanmehr@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Candidate patients for sleeve surgery Willing to cooperate ASA level one or two Having a BMI above 35 Age range from 16 to 76 years 16 years 76 years Both Patients with severe chest or upper abdominal pain (VAS more than 75). E66.01 Morbid (severe) obesity due to excess calories Prevention Prevention Prevention Intervention group: in the first intervention group, the intervention method is incentive spirometry. In this method, patients are placed in a sitting or semi-sitting position, and an incentive spirometry tube is placed in their mouth. They inhale and then hold their breath for 3-5 seconds and slowly exhale through the mouth as they remove the device. The patient performs this exercise 5 times two hours before the operation, two, six and ten hours after the operation. The average maximum inspiratory volume of the patient is recorded by incentive spirometry. Control group: in the control group, only routine cares will be done. Usual hospital cares include : drug treatment, checking vital signs, controlling patients' pain and encouraging patients to breathe deeply. Intervention group: the second intervention group, the intervention method is deep breathing exercise. In this method, the patient is sitting or semi-sitting, taking slow and deep breaths through the nose, at the same time, he presses the upper part of the abdomen with a pillow to reduce the pain. The patient inhales and then holds his breath for 3 to 5 seconds and exhales through pursed lips by squeezing the abdominal muscles. The patient performs this exercise 5 times two hours before the operation and two, six and ten hours after the operation. Blood oxygen saturation. Timepoint: Blood oxygen saturation is recorded two hours before surgery after using incentive spirometry and deep breathing exercise, during surgery and two, six and ten hours after surgery after using incentive spirometry and deep breathing exercise. The control group is also registered with the same pattern. Method of measurement: The way to measure blood oxygen saturation is by a portable pulse oximetry device. Heart rate. Timepoint: Heart rate is recorded two hours before surgery after using incentive spirometry and deep breathing exercise, during surgery and two, six and ten hours after surgery after using incentive spirometry and deep breathing exercise. The control group is also registered with the same pattern. Method of measurement: The way to measure the heart rate is by a portable pulse oximetry device. Blood pressure. Timepoint: Blood pressure is recorded two hours before surgery after using incentive spirometry and deep breathing exercise, during surgery and two, six and ten hours after surgery after using incentive spirometry and deep breathing exercise. The control group is also registered with the same pattern. Method of measurement: Blood pressure is measured by a sphygmomanometer. Blood PH. Timepoint: The level of blood PH is recorded two hours before the operation after using incentive spirometry and deep breathing exercise, during the operation and two, six and ten hours after the operation after using incentive spirometry and deep breathing exercise.The control group is also registered with the same pattern. Method of measurement: Blood PH is determined by venous blood gas analysis. Blood carbon dioxide. Timepoint: Blood carbon dioxide level is recorded two hours before the operation after using incentive spirometry and deep breathing exercise, during the operation and two, six and ten hours after the operation after using incentive spirometry and deep breathing exercise. The control group is also registered with the same pattern. Method of measurement: Blood carbon dioxide is determined by venous blood gas analysis. Pneumonia. Timepoint: The incidence of pneumonia after the surgery is checked by referring to the patient's file and examination of clinical symptoms by an expert up to two weeks. Method of measurement: Refer to the patient's file and check the clinical symptoms by the specialist. Atelectasis. Timepoint: The incidence of atelectasis after the surgery is checked by referring to the patient's file and examination of clinical symptoms by an expert up to two weeks. Method of measurement: Refer to the patient's file and check the clinical symptoms by the specialist. Length of hospitalization. Timepoint: The length of hospitalization is checked after the patient's discharge and by referring to the patient's file. Method of measurement: Referring to the patient's file. Mazandaran University of Medical Sciences Approved 2023-04-08 Ethics committee of Mazandaran University of Medical Sciences Journal office, Research and Technology Deputy,Third Floor,Building No2, Mazandaran University of Medical Sciences and Healthcare Services, Moalem Square, Sari Sari Mazandaran Iran (Islamic Republic of)