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IRCT20180321039135N1 IRCT 2018-09-04 Kerman University of Medical Sciences Study the effect of aromatherapy on patients after Percutaneous nephrolithotomy Comparing the effect of aromatherapy with lavender and Clary sage on Percutaneous nephrolithotomy postoperative pain, hemodynamic status, nausea and vomiting 2018-08-01 anticipated 90 Complete https://irct.ir/trial/30275 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The blocking method was used for randomization. For random allocation, the participants were divided into three groups, with a sample number of 30 in each group, randomization method was used. For this purpose, 15 blocks of 6 were used. In this method, the intervention and control groups are divided into three groups, A, B, C. Possible blocks were AABBCC, ABCABC, BACABC, CCBBAA, ABCCBA, CBACBA, numbers 1 to 6 were assigned to each of these blocks, respectively. Then the numbers from 1 to 6 were extracted from the random numbers table. (Obviously, in the case of extraction of the zero number, the number from 7 to 9 was again retrieved from the random number extraction), and it is selected in accordance with the extracted number of a block to identify 15 blocks. In the same way as the blocks are obtained, a list of 90 will be provided and the participants will be assigned respectively two groups A, B, and C respectively. N/A Percutaneous Nephrolithotomy (PCNL). Intervention 1: Intervention group 1: On each person, three interventions are performed after the operation. This is the first time after surgery in the operating room. The second and third turns are performed at 3 and 6 hours after surgery in the urological department. The intervention is stained with a sterile gas with 3 drops of aromatics (lavender) and placed at a distance of 10 cm from the nose of the patient and we instruct him to inhale for 5 minutes and 30 minutes after the intervention. We measure pain, hemodynamic status, and nausea in the patient's vomiting.All measurements for physiological indicators are performed at intervals of 5 to 10 minutes each time, and the average is recorded. Intervention 2: Intervention group 2: On each person, three interventions are performed after surgery. This is the first time after surgery in the operating room. The second and third turns are performed at 3 and 6 hours after surgery in the urological department. The intervention is stained with a 3-drops of aromatics (sage) and placed at a distance of 10 cm from the patient's nose and we instruct him to inhale for 5 minutes and 30 minutes after the intervention We measure the pain, hemodynamic status, and nausea in the patient's vomiting. All measurements for physiological indicators are performed at intervals of 5 to 10 minutes each time, and the average is recorded. Intervention 3: Control group: In the control group, blood pressure is taken from each person in three times and the relevant questionnaire is completed. The first turn is done after the work is done in the operating room. The second and third turns are performed at the 3rd and 6th hour after surgery in the urological department. All measurements for physiological indicators are performed at intervals of 5 to 10 minutes each time, and the average is recorded. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is still no plan to develop a program for sharing the data. According to the above sampling data time, the study will be completed by that time
public Mojdeh Amirhossaini
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3132 5856 m.amirhossaini@kmu.ac.ir Kerman University of Medical Sciences scientific Mahlagha Dehghan
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5856 m_dehghan86@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Patients undergoing Percutaneous nephrolithotomy Age 18-65 ASA classification I , II 18 years 65 years Both Coagulation disorder History of migraine and chronic headache History of allergy to medicinal herbs Meniere syndrome Respiratory problems during surgery Sensitiveness to aromatic substances A history of respiratory disease such as asthma, sinusitis and rhinitis Use hypnotics, sedative medicines or benzodiazepines a week before the onset of intervention Use the Aromatherapy for the patient within a week before the intervention begins Having psychological problems with doctor's diagnosis Treatment - Other Treatment - Other Treatment - Other Intervention group 1: On each person, three interventions are performed after the operation. This is the first time after surgery in the operating room. The second and third turns are performed at 3 and 6 hours after surgery in the urological department. The intervention is stained with a sterile gas with 3 drops of aromatics (lavender) and placed at a distance of 10 cm from the nose of the patient and we instruct him to inhale for 5 minutes and 30 minutes after the intervention. We measure pain, hemodynamic status, and nausea in the patient's vomiting.All measurements for physiological indicators are performed at intervals of 5 to 10 minutes each time, and the average is recorded. Intervention group 2: On each person, three interventions are performed after surgery. This is the first time after surgery in the operating room. The second and third turns are performed at 3 and 6 hours after surgery in the urological department. The intervention is stained with a 3-drops of aromatics (sage) and placed at a distance of 10 cm from the patient's nose and we instruct him to inhale for 5 minutes and 30 minutes after the intervention We measure the pain, hemodynamic status, and nausea in the patient's vomiting. All measurements for physiological indicators are performed at intervals of 5 to 10 minutes each time, and the average is recorded. Control group: In the control group, blood pressure is taken from each person in three times and the relevant questionnaire is completed. The first turn is done after the work is done in the operating room. The second and third turns are performed at the 3rd and 6th hour after surgery in the urological department. All measurements for physiological indicators are performed at intervals of 5 to 10 minutes each time, and the average is recorded. Systolic blood pressure average. Timepoint: At first and before the intervention, a blood pressure is measured once. The first intercourse is performed immediately after surgery in the operating room. Second and third interventions are performed 3 and 6 hours after the operation. In each intervention, the blood pressure is doubled at a time interval of 5 to 10 minutes, and then the average is recorded. All measurements related to blood pressure are performed 30 minutes after the intervention. Method of measurement: Digital Sphygmomanometer. Diastolic blood pressure average. Timepoint: At first and before the intervention, a Diastolic blood pressure is measured once. The first intercourse is performed immediately after surgery in the operating room. Second and third interventions are performed 3 and 6 hours after the operation. In each intervention, the blood pressure is doubled at a time interval of 5 to 10 minutes, and then the average is recorded. All measurements related to blood pressure are performed 30 minutes after the intervention. Method of measurement: Digital Sphygmomanometer. Incidence of nausea and vomiting. Timepoint: The first intermission is performed immediately after surgery in the operating room. Second and third interventions are performed 3 and 6 hours after the operation. All measurements for nausea and vomiting are performed 30 minutes after intervention. Method of measurement: Visual analog scale (VAS). Intensity of pain. Timepoint: The first intermission is performed immediately after surgery in the operating room. Second and third interventions are performed 3 and 6 hours after the operation. All measurements for nausea and vomiting are performed 30 minutes after intervention. Method of measurement: Visual pain assessment scale (VAS). Kerman University of Medical Sciences Approved 2018-07-11 Ethics Committee of Kerman University of Medical Sciences Kerman University Of Medical Sciences, Medical University Campus, Haft-Bagh Highway Kerman Kerman Iran (Islamic Republic of)