assessing the effect of inhalation of aromatherapy (Citrus aurantium) on post-operative pain after orthopedic surgery in lower limb

To determine the effect of aromatherapy with citrus aurantium essential oil on pain after orthopedic surgery

Experimental triple blind clinical trial study

This study is a randomized controlled clinical trial performed on 60 candidates for orthopedic surgery in Ayatollah Mousavi Hospital in Zanjan. In this study, patients were selected through convenience sampling based on inclusion criteria and then they were divided into intervention and control groups through randomized block allocation. Visual analogue scale (VAS) was used to collect data. The Pain was measured and recorded in both groups 4, 8 and 12 hours after surgery using VAS tool. If the VAS score was above 3, patients in the intervention group received aromatherapy with Citrus aurantium essential oil and the patients in the control group received aromatherapy with placebo (almond oil). During these three stages of intervention, 20 minutes after aromatherapy, pain was re-evaluated in both experimental and control groups using VAS.

Inclusion criteria :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. Exclusion criteria :Complications of post- surgery (bleeding, hematoma at the site of surgery) Need to oxygen therapy after surgery

The patients will be randomly divided into 2 groups: the first group will inhale 10% Citrus aurantium essential and the second group will inhale sweet almond

Post-operative pain

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.

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

Data sharing will be exclusively for Zanjan University of Medical Sciences

Up to 6 months after the completion of the project

Researchers working in Zanjan University of Medical Sciences

To do more research in this area with the permission of the Vice Chancellor for Research of Zanjan University of Medical Sciences

Nursing and Midwifery Faculty, Mahdavi Blvd, Karmandan settlement s.barghi7070@gmail.com

Submit a request to the Vice Chancellor for Research of Zanjan University of Medical Sciences