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IRCT20230209057374N1 IRCT 2023-04-13 Mazandaran University of Medical Sciences Comparison of the effect of deep breathing with and without rosemary on pain, sleep quality and hemodynamic indicators in upper limb orthopedic surgery. Comparison of the effect of deep breathing with and without rosemary on pain, sleep quality and hemodynamic indicators during and after upper limb orthopedic surgery 2023-02-20 anticipated 102 Complete https://irct.ir/trial/68567 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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: deep breathing without rosemary (B), deep breathing with rosemary (R). , control (C) or routine will be assigned. The blocks of this study are 6 (BB, RR, CC) and 27 states will be created, first determine the possible states of these 6 letters inside the blocks and then randomly and using the table of random numbers number 17 from the block. which will be the completion of the number of samples will be determined (1-27) and in this way the type of intervention will be determined based on the desired letters with the number of each patient and will be kept in a master sheet and the continuous entry number of the patients will be inserted on the envelope respectively And the type of intervention or control is specified inside the envelope. Gradually, according to the presence of eligible patients, the relevant envelope is returned, and the type of intervention that is inside the non-transparent envelope is determined and the desired technique is performed, Blinding description: In order to blind the patients, the same cotton necklace is used for all patients, although the cotton impregnated with rosemary essential oil contains perfume, an effort is made to ensure that there is no communication between the patients during the study period. And to blind the researchers, the opening of the envelope was done by the secretary of the department, who has no role in the evaluation of the groups, and the person who measures the variables is not aware of the type of intervention. Considering the different forms of providing services to the study groups, the behaviors in dealing with the three groups are tried to be similar in terms of having a cotton necklace dipped in rosemary oil or normal saline and without these items. However, it is not possible to completely blind due to the smell of rosemary. N/A Any tear or fracture in the upper limbs. Intervention 1: The first intervention group: Deep breathing with rosemary while the necklace containing three drops of 4% rosemary essential oil from the essential plant company is poured on cotton and is placed at a distance of 20 cm from the person's nose and the person inhales its aroma, at first there are explanations about Breathing skills, deep breathing and its effects on physical and mental health are given, then deep breathing training is first done lying down and then sitting up, before the surgery with the help of educational notes and the researcher's guidance by the patients, so that in terms of learning and the correct execution of the technique will be controlled and this training will be face-to-face. On the first day, they will do this exercise 12 times at the beginning of the day and 12 times in the evening before dinner, for 15 minutes. To perform abdominal breathing, the patient is taught to lie on his back on the floor and to bend his legs slightly apart from the hip width so that the lower back rests comfortably on the floor. Place the healthy hand on your stomach. Take a slow and deep breath through the nose while slowly expanding the abdominal muscles up and to the side and the belly expands, hold your breath for 5 seconds and then exhale slowly and smoothly through the nose. Exhale all the air from your lungs. The patient looks and pays attention to the abdominal muscles while inhaling and exhaling. Intervention 2: The second intervention group: deep breathing without rosemary while the necklace containing normal saline is poured on cotton and placed at a distance of 20 cm from the person's nose and the person inhales it, at first explanations about breathing skills, deep breathing and its effects It is given on physical and mental health, then deep breathing training is first done lying down and then sitting up, before the surgery with the help of educational notes and the guidance of the researcher, the patients will be controlled in terms of learning and doing the technique correctly, and this Training will be face-to-face. On the first day, they will do this exercise 12 times at the beginning of the day and 12 times in the evening before dinner, for 15 minutes. To perform abdominal breathing, the patient is taught to lie on his back on the floor and to bend his legs slightly apart from the hip width so that the lower back rests comfortably on the floor. Place the healthy hand on your stomach. Take a slow and deep breath through the nose while slowly expanding the abdominal muscles up and to the side and the belly expands, hold your breath for 5 seconds and then exhale slowly and smoothly through the nose. Exhale all the air from your lungs. The patient looks and pays attention to the abdominal muscles while inhaling and exhaling. Intervention 3: Control group: the routine procedures of the ward and operating room will be performed and recorded, and they will use a cotton necklace without rosemary and normal saline. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Ebrahim Nasiri Formi
Paramedical Faculty of Sari - University Complex of the Great Prophet - 17 km of Khazarabad Road - Khazar Square - Sari
Sari Iran (Islamic Republic of) 7771 +98 11 3354 3246 rezanf2002@yahoo.com Mazandaran University of Medical Sciences scientific Ebrahim Nasiri Formi
Paramedical Faculty of Sari - University Complex of the Great Prophet - 17 km of Khazarabad Road - Khazar Square - Sari
Sari Iran (Islamic Republic of) 7771 +98 11 3354 3246 rezanf2002@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Over 18 years of age The ability to read and write and communicate in Persian The presence of any fractures and tears in the upper limbs (which will take approximately 30 minutes to 3 hours for surgery) Being fully alert Not suffering from any disease have respiratory problems such as asthma, bronchitis and emphysema Not smoking Not pregnant or breastfeeding Not allergic to rosemary Class one and two anesthesia ASA1 and ASA2 18 years no limit Both Discontinuing the study Unwanted cardiovascular and respiratory complications during anesthesia and surgery Suffering from compartment syndrome XIII Diseases of the musculoskeletal system and connective tissue Treatment - Other Treatment - Other Treatment - Other The first intervention group: Deep breathing with rosemary while the necklace containing three drops of 4% rosemary essential oil from the essential plant company is poured on cotton and is placed at a distance of 20 cm from the person's nose and the person inhales its aroma, at first there are explanations about Breathing skills, deep breathing and its effects on physical and mental health are given, then deep breathing training is first done lying down and then sitting up, before the surgery with the help of educational notes and the researcher's guidance by the patients, so that in terms of learning and the correct execution of the technique will be controlled and this training will be face-to-face. On the first day, they will do this exercise 12 times at the beginning of the day and 12 times in the evening before dinner, for 15 minutes. To perform abdominal breathing, the patient is taught to lie on his back on the floor and to bend his legs slightly apart from the hip width so that the lower back rests comfortably on the floor. Place the healthy hand on your stomach. Take a slow and deep breath through the nose while slowly expanding the abdominal muscles up and to the side and the belly expands, hold your breath for 5 seconds and then exhale slowly and smoothly through the nose. Exhale all the air from your lungs. The patient looks and pays attention to the abdominal muscles while inhaling and exhaling. The second intervention group: deep breathing without rosemary while the necklace containing normal saline is poured on cotton and placed at a distance of 20 cm from the person's nose and the person inhales it, at first explanations about breathing skills, deep breathing and its effects It is given on physical and mental health, then deep breathing training is first done lying down and then sitting up, before the surgery with the help of educational notes and the guidance of the researcher, the patients will be controlled in terms of learning and doing the technique correctly, and this Training will be face-to-face. On the first day, they will do this exercise 12 times at the beginning of the day and 12 times in the evening before dinner, for 15 minutes. To perform abdominal breathing, the patient is taught to lie on his back on the floor and to bend his legs slightly apart from the hip width so that the lower back rests comfortably on the floor. Place the healthy hand on your stomach. Take a slow and deep breath through the nose while slowly expanding the abdominal muscles up and to the side and the belly expands, hold your breath for 5 seconds and then exhale slowly and smoothly through the nose. Exhale all the air from your lungs. The patient looks and pays attention to the abdominal muscles while inhaling and exhaling. Control group: the routine procedures of the ward and operating room will be performed and recorded, and they will use a cotton necklace without rosemary and normal saline. Pain score. Timepoint: Recording the pain score of the operation site at the time of discharge from recovery and 24 hours, 48 hours, 4 days and 7 days after surgery. Method of measurement: Visual Analog Scale. Tourniquet site pain score. Timepoint: Discharge from recovery and 24 hours after the operation. Method of measurement: Visual Analog Scale. Evaluation of sleep quality. Timepoint: Evaluation of sleep quality the night before and the first night after surgery, as well as 48 hours, 4 days and 7 days after surgery. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Examining waking up during anesthesia, symptoms include: dizziness, rapid meiosis in response to light, tears, targeted movements of facial muscles and limbs, sweating, tachycardia, and increased blood pressure in response to painful stimulation (skin incision). Timepoint: The beginning of surgery (skin incision) and the end of surgery (skin suture). Method of measurement: Dizziness, rapid meiosis in response to light, tears, targeted movements of facial muscles and limbs, sweating, tachycardia, and increased blood pressure in response to painful stimulation (skin incision). Examining recall of events during anesthesia with questions: hearing the sounds during the operation, feeling the stretch of the viscera and feeling the pain. Timepoint: In 24 hours and 7 days after anesthesia. Method of measurement: Hearing the sounds during the operation, feeling the stretch of the viscera and feeling the pain. Registration of hemodynamic indicators including: systolic and diastolic blood pressure, heart rate and arterial blood oxygen. Timepoint: Entering the operating room, during the operation and at the time of discharge from recovery. Method of measurement: Monitoring device. Mazandaran University of Medical Sciences Approved 2023-01-16 Ethics Committee of Mazandaran University of Medical Sciences Journal Office - Research and Technology Deputy - Third Floor - Building No. 2, Mazandaran University of Medical Sciences and Healthcare Services - Moalem Square - Sari Sari Mazandaran Iran (Islamic Republic of)