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IRCT20140304016843N13 IRCT 2021-01-01 Zanjan University of Medical Sciences The effect of inhalation of aromatherapy (Citrus aurantium) on postoperative pain assessing the effect of inhalation of aromatherapy (Citrus aurantium) on post-operative pain after orthopedic surgery in lower limb 2018-10-29 anticipated 60 Complete https://irct.ir/trial/52943 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Experimental triple blind clinical trial study, Randomization description: Candidate patient for orthopedic surgery will be selected through convenience sampling and will be divided into experimental and control groups by block random allocation method. To create two identical groups, first for each of group will be allocated letters A and B. Size of blocks will be four. After itemizing approximate all possible modes of 4 blocks (AABB, ABAB, BABA, BBAA, ABBA, BAAB) and assigning a number to each one, based on a random number table, 15 blocks will select to increase the number of samples to 60 people (30 people in the experimental group, 30 people in the placebo group). To allocate patients in the experimental or control groups, the type of intervention will be written on the envelope group A (i.e., Citrus aurantium) and group B (i.e., placebo). Envelopes will be arranged sequentially in random order. The patient will allocate to either of the groups based on the envelope label, Blinding description: In this study patients will be informed that they will participate in study but they will not know that they are in the experimental group or in the control group. Research assistances who will perform the intervention or evaluate the results of the intervention will not know that which group are the experimental group and which group are the control group .Citrus aurantium and placebo will be given to research assistants in the form two containers with the names A and B and will not be given explanatory about content of the container for them. Also, the research assistant who assessed pain after the intervention will not be informed of the experimental or control groups. The experimental and control groups will be introduced to someone who analyzes the results as groups A and B. Though, the fragrance of Citrus aurantium and sweet almond oil are different. But none of the patients knew they will in the experimental or control group. Also, for the research assistant who performed the intervention, Citrus aurantium will again introduce as drug A and almond oil as drug B. As mentioned earlier, the fragrance of Citrus aurantium is not the same as almond oil .The almond oil was selected as a placebo based on the opinion of an expert in pharmacognosy, because almond oil is not volatile and cannot be absorbed by inhalation. In addition, during the intervention, patients will be in a separate room in the intervention and control groups. On the other hand, patients will not know whether they are in the control group or in the control group. N/A post-operative pain. Intervention 1: In the experimental group, if the patients who underwent lower orthopedic surgery, their pain score by using VAS instrument was more than 3 after 4,8,12 hours after surgery, 4 drops of Citrus aurantium essential oil was poured on a cotton ball and the patient was asked to inhale it for 5 minutes at a distance of 20 CM. Then, after 20 minutes, the pain intensity was measured again on the visual analogue scale. Intervention 2: Control group: In the control group, similar to the intervention group at 4.8,12 hours after surgery, the severity of pain was assessed using the VAS instrument. If their postoperative pain score was more than 3, they were treated with sweet almond oil and then 20 minutes later - similar to experimental group, their pain intensity was assessed and recorded. Patients in both groups also received routine medications to relieve pain. Patients selected for experimental group were evaluated for allergy to Citrus aurantium essential oil by skin patch test containing Citrus aurantium before intervention. Yes - There is a plan to make this available What will be shared: Data sharing will be exclusively for Zanjan University of Medical Sciences When: Up to 6 months after the completion of the project To whom: Researchers working in Zanjan University of Medical Sciences Conditions: To do more research in this area with the permission of the Vice Chancellor for Research of Zanjan University of Medical Sciences Where to obtain: Nursing and Midwifery Faculty, Mahdavi Blvd, Karmandan settlement s.barghi7070@gmail.com How to obtain: Submit a request to the Vice Chancellor for Research of Zanjan University of Medical Sciences Comments:
public Sepideh Barghi
Nursing and Midwifery Faculty, Mahdavi Blvd, Karmandan settlement
zanjan Iran (Islamic Republic of) ۴۵۱۳۹۵۶۱۱۳ +98 24 3314 8318 s.barghi7070@gmail.com Zanjan University of Medical Sciences scientific Dr Nasrin Bahraminejad
School of Nursing and Midwifery, Mahdavi Blvd, Karmandan settlement
Zanjan Iran (Islamic Republic of) ۴۵۱۳۹۵۶۱۱۳ +98 24 3314 8325 bahrami_n@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Desiring to participate in the study - Having full awareness and cooperation - Healthy smell status - Not having: Coagulation disorder, Diabetes, Breathing disorder - Not having a history of allergy to plants - Having a fracture of the lower part of the femur and legs- Healthy visual and mind status to see and understand VAS tool - Not having surgery history Being older than 15 years old and older - Not having previous surgical experience and no drug addiction 15 years no limit Male Complications of post- surgery (bleeding, hematoma at the site of surgery) Need to oxygen therapy after surgery Patient’s unwillingness to participate in the study after first intervention G89.18 Other acute postprocedural pain Treatment - Other Treatment - Other In the experimental group, if the patients who underwent lower orthopedic surgery, their pain score by using VAS instrument was more than 3 after 4,8,12 hours after surgery, 4 drops of Citrus aurantium essential oil was poured on a cotton ball and the patient was asked to inhale it for 5 minutes at a distance of 20 CM. Then, after 20 minutes, the pain intensity was measured again on the visual analogue scale. Control group: In the control group, similar to the intervention group at 4.8,12 hours after surgery, the severity of pain was assessed using the VAS instrument. If their postoperative pain score was more than 3, they were treated with sweet almond oil and then 20 minutes later - similar to experimental group, their pain intensity was assessed and recorded. Patients in both groups also received routine medications to relieve pain. Patients selected for experimental group were evaluated for allergy to Citrus aurantium essential oil by skin patch test containing Citrus aurantium before intervention. Post operative pain. Timepoint: In 4, 8, and 12 hours after the transfer of the patient from the operating room to the surgical unit. Method of measurement: Visual analog Scale. Zanjan University of Medical Sciences Approved 2018-05-07 Ethics Committee of Zanjan University of Medical Sciences Zanjan University of Medical Sciences, Azadi blvd Zanjan Zanjan Iran (Islamic Republic of)