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IRCT20230208057364N1 IRCT 2023-03-10 Mazandaran University of Medical Sciences Comparison of the effect of massage with and without black seed oil on pain, nausea and vomiting of caesarean section patients using lumbar anesthesia. Comparison of the effect of foot reflexology massage with and without black seed oil on pain, nausea and vomiting, hemodynamic indicators and recovery quality of elective caesarean section patients under spinal anesthesia. 2023-02-19 anticipated 102 Complete https://irct.ir/trial/68571 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Parallel randomized clinical trial - patients are continuously referred and then entered into the study based on the type of random allocation. This research will be allocated to three groups of foot reflex massage with oil (O), foot reflex massage without oil (W), control (C) or routine before starting the study by block randomization method. The blocks of this research are 6 (OO, WW, CC) and 27 states will be created. First, the possible states of these 6 letters inside the blocks will be determined, and then the numbers of the blocks will be determined in a simple random manner using a table of random numbers. In this way, the type of intervention based on the desired letters will be determined with the number of each patient and will be kept in a master sheet, and finally, the intervention number of each patient will be inserted on a sheet when visiting and the type of intervention will be known at that moment (entry number The patient records are entered on the envelope and the type of intervention or control is specified inside the envelope. Gradually, according to the presence of eligible patients, the corresponding envelope is returned, and the type of intervention that is inside the non-transparent envelope is specified, and the desired technique will be done.). N/A Nausea and vomiting - pain - duration of discharge from recovery - hemodynamic indicators - digestive index (constipation) - shaving - urinary output - reflex massage - cesarean section - spinal anesthesia - black seed. Intervention 1: Intervention group: The first intervention group: The intervention group (reflex massage of the soles of the feet): pressure on three sensitive points, which are the solar plexus, pituitary gland, and heart, with the thumb. This pressure is to the extent that the upper third of the researcher's thumb turns white, and then massage is given to all the soles of the feet in a circular manner. The meaning of massage in this study is a 20-minute foot massage (10 minutes after the patient is stabilized on the operating bed and 10 minutes during recovery and 3 seconds of rest for every 2 minutes of direct pressure). The movement of the thumb or other fingers is circular clockwise and continuously on the reflective points without breaking the contact with the skin and will be done with black seed oil (Barij company).Before the intervention, in order for the researcher's hand to have more contact with the massage area, the patient's feet were first cleaned using a wet towel, then the researcher performed reflex foot massage without using cream or emollient with black seed oil in the intervention group for 20 minutes (10 minutes for each foot) and it is done first on the left foot and then on the right foot. If there is edema in the client's leg, more pressure is applied to perform the techniques. Intervention 2: Intervention group: The second intervention group: reflex massage of the soles of the feet: pressure on three sensitive points, which are the solar plexus, pituitary gland, and heart, with the thumb. This pressure is to the extent that the upper third of the researcher's thumb turns white, and then massage is given to all the soles of the feet in a circular manner. The meaning of massage in this study is a 20-minute foot massage (10 minutes after the patient is stabilized on the operating bed and 10 minutes during recovery and 3 seconds of rest for every 2 minutes of direct pressure). The movement of the thumb or other fingers is circular in the clockwise direction and continuously on the reflex points without breaking the contact with the skin and will be done with baby oil (Firooz Company). First, the patient's feet were cleaned using a wet towel, then the researcher performed a reflex foot massage without using cream or softener with black seed oil in the intervention group for 20 minutes (10 minutes on each foot, first on the left foot and then on the right foot). will be If there is edema in the client's leg, more pressure is applied to perform the techniques. Intervention 3: Control group: The touch without pressure will be applied with the same pattern as the sole reflex massage groups as a superficial and gentle massage at the same point. 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 Dr. Ebrahim Nasiri
Kilometer 17 of Farah Abad Road, Prophet Azam University Complex, Faculty of Paramedicine
Sari Iran (Islamic Republic of) 7771 +98 11 3354 2469 rezanf2002@yahoo.com Mazandaran University of Medical Sciences scientific Dr. Ebrahim Nasiri
Prophet Azam University Complex, Paramedical FacultyKm 17 Khazar Abad Road,Khazar Square
Sari Iran (Islamic Republic of) 7771 +98 11 3354 2469 rezanf2002@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Term of pregnancy Being 18-45 years old Not having a lesion at the place of application of touch Insensitivity to touch or massage No drug addiction Having no problems in speech, hearing and vision Not having known mental disorders Elective caesarean section Not having spinal restrictions No medical problems and no midwifery problems after surgery such as heavy bleeding Not having crises such as a history of divorce, loss of loved ones and immigration in the last 6 months 18 years 45 years Female The presence of spinal contraindications Presence of preeclampsia Emergency caesarean section Conversion of spinal anesthesia to general anesthesia for any reason Hemodynamic instability Lack of consent to participate in the research Migration Divorce Prevention Prevention Placebo Intervention group: The first intervention group: The intervention group (reflex massage of the soles of the feet): pressure on three sensitive points, which are the solar plexus, pituitary gland, and heart, with the thumb. This pressure is to the extent that the upper third of the researcher's thumb turns white, and then massage is given to all the soles of the feet in a circular manner. The meaning of massage in this study is a 20-minute foot massage (10 minutes after the patient is stabilized on the operating bed and 10 minutes during recovery and 3 seconds of rest for every 2 minutes of direct pressure). The movement of the thumb or other fingers is circular clockwise and continuously on the reflective points without breaking the contact with the skin and will be done with black seed oil (Barij company).Before the intervention, in order for the researcher's hand to have more contact with the massage area, the patient's feet were first cleaned using a wet towel, then the researcher performed reflex foot massage without using cream or emollient with black seed oil in the intervention group for 20 minutes (10 minutes for each foot) and it is done first on the left foot and then on the right foot. If there is edema in the client's leg, more pressure is applied to perform the techniques. Intervention group: The second intervention group: reflex massage of the soles of the feet: pressure on three sensitive points, which are the solar plexus, pituitary gland, and heart, with the thumb. This pressure is to the extent that the upper third of the researcher's thumb turns white, and then massage is given to all the soles of the feet in a circular manner. The meaning of massage in this study is a 20-minute foot massage (10 minutes after the patient is stabilized on the operating bed and 10 minutes during recovery and 3 seconds of rest for every 2 minutes of direct pressure). The movement of the thumb or other fingers is circular in the clockwise direction and continuously on the reflex points without breaking the contact with the skin and will be done with baby oil (Firooz Company). First, the patient's feet were cleaned using a wet towel, then the researcher performed a reflex foot massage without using cream or softener with black seed oil in the intervention group for 20 minutes (10 minutes on each foot, first on the left foot and then on the right foot). will be If there is edema in the client's leg, more pressure is applied to perform the techniques. Control group: The touch without pressure will be applied with the same pattern as the sole reflex massage groups as a superficial and gentle massage at the same point. Determining the postoperative pain level of patients at the time of discharge from recovery, 24 and 48 hours after surgery in caesarean section patients in the reflex massage groups with and without black seed oil and their control group, this scale was a ten-centimeter horizontal ruler ranging from zero to It was graded ten. The number zero indicated the absence of pain symptoms and the number ten meant the maximum intensity of the desired symptoms. Timepoint: Post-operative pain level, recovery time, 24 and 48 hours after the operation and after reflexology massage with and without black seed oil. Method of measurement: Visual analogue scale is used to measure the pain of the operation site. Determining the severity of nausea in patients during surgery, after surgery and 24 hours after surgery in caesarean section patients of reflexology massage groups with and without black seed oil and their control group, the visual scale for registering the severity of nausea is a self-report scale. Nausea with a grade above 7 is classified as severe, between 3.5 and 7 as moderate, and less than 3.5 as mild. Timepoint: Determining the severity of nausea in patients during surgery, after surgery and 24 hours after surgery and after reflexology massage with and without black seed oil. Method of measurement: Visual scale. To evaluate the amount of vomiting, counting the number of times vomiting is used. Vomiting more than 5 times is defined as severe, between 3-5 times as moderate and less than 3 times as mild. Timepoint: The amount of nausea and vomiting is measured after the intervention, during the operation, after the operation and 24 hours after the operation. Method of measurement: Visual scale. Measurement of hemodynamic indicators (systolic and diastolic blood pressure, pulse and spo2). Timepoint: Before the operation, after the birth of the baby and after the last suture in the cesarean section. Method of measurement: Monitoring device. Measuring the duration of recovery in two time periods. Timepoint: The moment of entering recovery and the time of discharge from recovery after applying massage. Method of measurement: It is recorded in minutes. Determining postoperative headache in patients. Timepoint: Recovery time, 24 and 48 hours after the operation. Method of measurement: The measurement of headache is a visual analogue scale, this scale was a ten-centimeter horizontal ruler graded from zero to ten. The number zero indicates the absence of pain symptoms and the number ten means the maximum intensity of the symptoms. 2. Determining shivering of patients. Timepoint: During recovery. Method of measurement: By observing the patient during recovery and at four levels, the absence of muscle tremors is scored as zero, straightening of hair, peripheral cyanosis: 1, visible muscle tremors in one muscle group: 2, visible muscle tremors in more than one muscle group: 3 and muscle tremors. Visible in all the muscles of the body: 4. 6. Digestive index (constipation). Timepoint: 24 and 48 hours after the operation. Method of measurement: The checklist of digestive complications is constipation. Constipation by asking the patient and the information entered in the patient's file in terms of passing gas, straining, flatulence, abdominal pain, firm consistency, lack of defecation. Determination of urinary output of patients. Timepoint: During operation, exit from recovery and 12 hours later in patients. Method of measurement: Urinary output is measured by a questionnaire. After the implementation of foot reflex massage interventions with and without black seed oil through the inserted urinary catheter, he will do it by observing the urine bag and the patient's file. Mazandaran University of Medical Sciences Approved 2023-02-14 Ethics committee of Mazandaran University of Medical Sciences Serah Joibar, the beginning of Vali Asr Highway (AJ), the headquarters of Mazandaran University of Medical Sciences and Health Services Amol Mazandaran Iran (Islamic Republic of)