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IRCT20211124053172N1 IRCT 2022-01-01 Kerman University of Medical Sciences The effect of aromatherapy with lavender and cloves on headache severity caused by spinal anesthesia Comparison of the effect of aromatherapy with lavender and cloves on headache severity caused by spinal anesthesia in patients undergoing urological surgery in Bahonar Hospital in Kerman in 2021-2022 2021-12-11 anticipated 90 Complete https://irct.ir/trial/60394 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients who met the inclusion criteria were selected by convenience sampling method and randomly divided into three groups: aromatherapy with lavender, aromatherapy with cloves and control. To compile a random list, the online software https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used, the size of the blocks will be 6 and the two variables of gender (male / female) and age ( Less than 30 years old) will be considered as classes when creating a random list, Blinding description: At the beginning of the intervention, patients in the intervention group separately in the recovery so that other patients are not exposed to inhalation of the drug by one of the operating room staff who is not present in the study, A sterile gas with 3 drops of fragrance with the desired concentration of 5% (lavender or clove) is impregnated and placed at a distance of 10 cm from the patient's nose and the patient inhales it for 5 minutes This is repeated 8 hours and 24 hours later, and 30 minutes after the second and third interventions, the amount of pain is measured and recorded. The second intervention (8 hours after the operation) and the third (24 hours after the operation) are performed there due to the transfer of the patient to the urology department.In patients in the control group, inhalation of gas impregnated with normal saline is performed and 8 and 24 hours after surgery are examined for the desired variable. In the control group, no intervention is performed.And receive routine care as usual. In addition, all medications received by patients in a total of 24 hours after surgery are recorded in all three intervention and control groups.Also, the environmental conditions, including closing the doors and windows, minimizing the pleasant and unpleasant odors in the ward, are equalized for the three groups. Also, the two intervention groups were placed in separate rooms. 3 patients undergoing urological surgery. Intervention 1: Intervention group 1: At the beginning of the intervention, patients in the intervention group separately in recovery so that other patients are not exposed to inhalation of the drug, a sterile gas with 3 drops of lavender with a concentration of 5% impregnated and placed 10 cm from the patient's nose It is taken and the patient inhales it for 5 minutes, and this is repeated 8 hours and 24 hours later, and 30 minutes after the second and third interventions, the amount of pain is measured and recorded. The second intervention (8 hours after the operation) and the third (24 hours after the operation) are performed there due to the transfer of the patient to the urology department. Intervention 2: Intervention group 2: At the beginning of the intervention, patients in the intervention group separately in recovery so that other patients are not exposed to inhalation of the drug, a sterile gas with 3 drops of cloves with a concentration of 5% impregnated and placed 10 cm from the patient's nose It is taken and the patient inhales it for 5 minutes, and this is repeated 8 hours and 24 hours later, and 30 minutes after the second and third interventions, the amount of pain is measured and recorded. The second intervention (8 hours after the operation) and the third (24 hours after the operation) are performed there due to the transfer of the patient to the urology department. Intervention 3: Control group: There is no intervention in the control group and they receive routine care as usual. 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 more information.
public Atena Samareh Fekri
No 22 , Blv jomhouri 13
Kerman Iran (Islamic Republic of) 00000000000 +98 34 3211 3491 atena.samarehfekri@gmail.com Kerman University of Medical Sciences scientific Atena Samareh Fekri
No 22 , Blv jomhouri 13
Kerman Iran (Islamic Republic of) 00000000000 +98 34 3211 3491 atena.samarehfekri@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) No previous history of spinal anesthesia Classes 1 and 2 based on ASA classification Lack of blindness and deafness due to the use of visual pain scale No history of migraine and chronic headache Lack of sensitivity to aromatic substances No history of respiratory disease such as asthma, sinus disorders and rhinitis Do not use aromatherapy for the patient for a week before the intervention No mental health problems with a doctor's diagnosis Perform anesthesia by an anesthesiologist with a needle of the same size with just one attempt No coagulation disorders 18 years 60 years Both Perform re-spinal anesthesia Induction of general anesthesia Having an absolute rest of more than 8 hours Emergence of skin and respiratory allergies in the patient Preoperative headache pregnant women urological surgery Prevention Prevention Prevention Intervention group 1: At the beginning of the intervention, patients in the intervention group separately in recovery so that other patients are not exposed to inhalation of the drug, a sterile gas with 3 drops of lavender with a concentration of 5% impregnated and placed 10 cm from the patient's nose It is taken and the patient inhales it for 5 minutes, and this is repeated 8 hours and 24 hours later, and 30 minutes after the second and third interventions, the amount of pain is measured and recorded. The second intervention (8 hours after the operation) and the third (24 hours after the operation) are performed there due to the transfer of the patient to the urology department. Intervention group 2: At the beginning of the intervention, patients in the intervention group separately in recovery so that other patients are not exposed to inhalation of the drug, a sterile gas with 3 drops of cloves with a concentration of 5% impregnated and placed 10 cm from the patient's nose It is taken and the patient inhales it for 5 minutes, and this is repeated 8 hours and 24 hours later, and 30 minutes after the second and third interventions, the amount of pain is measured and recorded. The second intervention (8 hours after the operation) and the third (24 hours after the operation) are performed there due to the transfer of the patient to the urology department. Control group: There is no intervention in the control group and they receive routine care as usual. Pain score on the VAS scale. Timepoint: Pain measurement at the beginning of the study (before the intervention) and 30 minutes after the second intervention (8 hours after surgery) and the third (24 hours after surgery). Method of measurement: Visual Analog Scale (VAS). Kerman University of Medical Sciences Approved 2021-11-08 Kerman University of Medical Sciences campus of Kerman University of Medical Sciences, The beginning of Haft Bagh Alavi axis Kerman Kerman Iran (Islamic Republic of)