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IRCT20100919004775N14 IRCT 2022-11-16 Shiraz University of Medical Sciences The effect of aromatherapy with rose flowers on pain and anxiety before and after surgery The effect of aromatherapy with rose on anxiety and pain of patients before and after Endoscopic lithotripsy procedure 2022-10-23 anticipated 120 Complete https://irct.ir/trial/66206 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Experimental study of a three-blind clinical trial, Randomization description: The researcher will select the samples according to the conditions of entering the study and based on the purpose, in the form of available sampling. For randomization, permutation blocks will be used to assign people to two control and intervention groups. The samples are selected from two centers and are allocated in these classes by the method of alternating blocks of samples. Based on the sample size and the number of groups, 60 people will be allocated in each group and then the samples will be allocated to 5 blocks of 6 in each center. The random allocation list is prepared by online software on the web, Blinding description: In this study, the information will be informed that they will participate in a study, but they did not realize that they are in the control group or in the intervention group. The help of the researchers who conduct the intervention, I do not know which group is the experimental group, part of the group, and which group is the control group. Bottles of rose essential oil and placebo will be introduced with the help of researchers in the form of drug A and drug B. Also, helping the patients who evaluates the pain and the doctor before and after the intervention, I don't know which patient is in the intervention group and which patient is in the control group.For the one who will analyze the results, the intervention and control group will be introduced as group A and B. For the research assistant who will carry out the intervention, rose essence will be introduced as drug A and distilled water as drug B. In addition, during the study, the patients in the intervention group and the control group will be tried to be in separate rooms. On the other hand, the patients will not want to know whether they are in the control group or the control group. N/A Pain before and after surgery. Intervention 1: Intervention group:All patients will complete relevant questionnaires (demographics, pain intensity and anxiety) before aromatherapy. In the intervention group, 6 hours before the surgery, the researcher will soak the cotton with three drops of rose essential oil (provided by Barich Essential Oil Company, Kashan) and install it at a distance of 10 cm on the patient's clothes with a plastic pin, and then ask him You can breathe normally. When the patient is waiting in the operating room and in the preparation room before the operation,the severity of their pain and anxiety is also completed once again by the project partner. In the operating room, all patients are anesthetized by spinal anesthesia with Markain 10 mg and spinal needle number 25.After completing the surgery and reconnecting with the patients in the recovery room, the researcher will apply 3 drops of rose essential oil on cotton and place it on the patient's clothes at a distance of 10 cm, and he will be asked to wait for 6 Breathe normally. 6 hours after the surgery, the researcher will again measure the pain intensity and the level of anxiety of the patients using the mentioned questionnaires. Intervention 2: Control group: All patients will complete relevant questionnaires (demographics, pain intensity and anxiety) before aromatherapy. In the intervention group, 6 hours before the surgery, the researcher will soak the cotton with distilled water and attach it to the patient's clothes with a plastic pin at a distance of 10 cm, and then he will be asked to breathe normally. When the patient is waiting in the operating room and in the preparation room before the operation, the intensity of their pain and anxiety is also completed again by the project partner.In the operating room, all patients are anesthetized by spinal anesthesia with Markain 10 mg and spinal needle number 25. After the surgery is completed and reconnecting with the patients in the recovery room, the researcher again smears the distilled water on the cotton and It will be installed on the patient's clothes at a distance of 10 cm and he will be asked to breathe normally for 6 hours. 6 hours after the surgery, the researcher will again measure the pain intensity and the level of anxiety of the patients using the mentioned questionnaires. Yes - There is a plan to make this available What will be shared: We do not have data yet When: Access period starts after publish the article To whom: All people Conditions: For Operation Room Personnel Where to obtain: Corresponding Author How to obtain: Is email to Corresponding Author. Comments:
public Maryam Mohit
No 43,Yasaman Ave,Gulf of Fars Blvd
Shiraz Iran (Islamic Republic of) 7159764479 +98 71 3741 9784 maryammohit71@gmail.com Shiraz University of Medical Sciences scientific Zinat Mohebbi
Sadra - Danesh Blvd. - Eram St. - Farhang St. in front of Farhang 3
Shiraz Iran (Islamic Republic of) 7199414477 26033641 Mohebbi04@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Enjoying mental-psychological health No hearing or speech impairment Hemodynamic stability Absence of chronic pain No use of anti-anxiety and pain relievers Olfactory health No history of food and seasonal allergies no limit no limit Both Addicted people or those who use narcotic drugs or painkillers for a long time Patients who need medication or measures other than routine care during surgery to eliminate complications and reduce pain intensity Expression of disapproval to continue the research G89.18 Other acute postprocedural pain Treatment - Other Treatment - Other Intervention group:All patients will complete relevant questionnaires (demographics, pain intensity and anxiety) before aromatherapy. In the intervention group, 6 hours before the surgery, the researcher will soak the cotton with three drops of rose essential oil (provided by Barich Essential Oil Company, Kashan) and install it at a distance of 10 cm on the patient's clothes with a plastic pin, and then ask him You can breathe normally. When the patient is waiting in the operating room and in the preparation room before the operation,the severity of their pain and anxiety is also completed once again by the project partner. In the operating room, all patients are anesthetized by spinal anesthesia with Markain 10 mg and spinal needle number 25.After completing the surgery and reconnecting with the patients in the recovery room, the researcher will apply 3 drops of rose essential oil on cotton and place it on the patient's clothes at a distance of 10 cm, and he will be asked to wait for 6 Breathe normally. 6 hours after the surgery, the researcher will again measure the pain intensity and the level of anxiety of the patients using the mentioned questionnaires Control group: All patients will complete relevant questionnaires (demographics, pain intensity and anxiety) before aromatherapy. In the intervention group, 6 hours before the surgery, the researcher will soak the cotton with distilled water and attach it to the patient's clothes with a plastic pin at a distance of 10 cm, and then he will be asked to breathe normally. When the patient is waiting in the operating room and in the preparation room before the operation, the intensity of their pain and anxiety is also completed again by the project partner.In the operating room, all patients are anesthetized by spinal anesthesia with Markain 10 mg and spinal needle number 25. After the surgery is completed and reconnecting with the patients in the recovery room, the researcher again smears the distilled water on the cotton and It will be installed on the patient's clothes at a distance of 10 cm and he will be asked to breathe normally for 6 hours. 6 hours after the surgery, the researcher will again measure the pain intensity and the level of anxiety of the patients using the mentioned questionnaires Pain before and after surgery. Timepoint: 6 hours before the operation - immediately after the intervention - 6 hours after the operation. Method of measurement: Visual analog Scale. Anexiety before and after surgery. Timepoint: 6 hours before the operation - immediately after the intervention - 6 hours after the operation. Method of measurement: Spielberger questionnaire. Chancellor for Research and Technology of Shiraz University of Medical Sciences Approved 2022-10-08 Ethics Committee Faculty of Nursing and Midwifery of Shiraz University of Medical Sciences Faculty of Nursing and Midwifery, Namazi Hospital, Zand Street Shiraz Fars Iran (Islamic Republic of)