کارآزمایی بالینی تصادفی شده

Randomized clinical trials are the gold standard for evaluating the effectiveness and safety of medical interventions. Some unpredictable challenges may affect the results of these studies. Therefore, the aim of this study was to identify the challenges of clinical trial studies in different stages including design, conduct, analysis, and reporting.

This study was a qualitative study using content analysis performed from 2017 to 2019. The study population included 13 clinical trial experts who were selected through purposeful sampling. Semi-structured interviews were conducted with all subjects. Data saturation was achieved after 13 interviews.

Among the 4 steps of design, conduct, analysis, and reporting, the majority of the challenges were related to conducing randomized clinical trials. Lack of knowledge of researchers, subjects, sponsors and physicians and supervisory and ethical challenges were the main challenges related to performing these studies. Poor design and lack of clinical equipoise were considered as the main challenges in the design step. Inappropriate analytical methods due to the absence of statistician in these studies were considered as the most common challenge related to analysis. Finally, lack of familiarity with international guidelines was the most important challenge in reporting.

There are many challenges in different steps of clinical trial studies. Therefore, additional education sessions focusing on the related guidelines and standards as well as GCP workshops for researchers can be helpful.

Diabetes mellitus (DM) is a major epidemic public health problem of the 20th century. One of the most common complications of DM is peripheral neuropathy. This complication remains a big unsolved challenge for DM patients, endocrinologists, and nurses. The purpose of this study was to investigate the effectiveness of a warm foot bath on peripheral neuropathy in diabetic patients.

This randomized clinical trial was conducted on 70 diabetic patients at the Yazd Diabetes Research Center, Yazd, Iran. The study population was selected using the convenience sampling technique. They were randomly assigned into two groups of control (receiving routine care) and intervention (receiving routine care plus a warm foot bath). A warm foot bath was administered for 8 sessions lasting 20 min every other day, over 2 weeks. The data collection tool (i.e., a questionnaire) was completed by interviewing and examination in three phases (i.e., before the intervention and two weeks and one month after the intervention). The data were analyzed in SPSS software.

According to results, the mean neuropathy scores were obtained as 7.24, 4.51, and 4.39 before the intervention, two weeks post-intervention, and one month after the intervention, respectively. Based on the physical examination, these values were estimated at 4.09, 3.12, and 2.90 for the mentioned time points, respectively. With regard to the control group, the mean neuropathy scores in the three phases were respectively 7.48, 7.7, and 6.78 based on the history taking and 4.33, 4.7, and 3.84 according to the physical examination. The results revealed a significant difference between the intervention and control groups in terms of the posttest mean neuropathic score (P<0.001).

Considering the mean changes in peripheral neuropathy in diabetic patients, a warm foot bath can be recommended as an effective and simple nonpharmacological and home care intervention. However, it is required to perform further research in this domain.

The study was designed to determine the effect of thirty days of pomegranate extract oral supplementation on plasma inflammatory and oxidative stress biomarkers as well as serum metabolic profiles, in overweight and obese individuals.

In this randomized, double-blind, placebo-controlled study 48 obese and overweight participants were randomly assigned to receive either 1000 mg of pomegranate extract (PE), or a placebo (PL), daily for 30 days. At baseline, and after 30 days of treatment, anthropometric parameters, dietary intake, plasma concentrations of malondialdehyde (MDA), interleukin-6 (IL-6) and hyper sensitive-C reactive protein (hs-CRP) and levels of serum lipids, glucose and insulin were assessed.

Thirty days of PE supplementation resulted in a significant decrease in mean serum levels of glucose, insulin, total cholesterol, LDL-C, and plasma MDA, IL-6 and hs-CRP. HDL-C significantly increased following the PE versus the PL intervention.

Our study suggests that pomegranate extract consumption may reduce complications linked with obesity through ameliorating the systemic inflammation and lipid profile. Future studies with larger sample size are required to verify these results.

Enoxaparin using in cardiac patients to prevent the development, of coronary artery bypass grafting. The pain of the injection location is an unfavorable result subcutaneous injection of enoxaparin, causes patient discomfort. The aim of this study was to evaluate the effect of lavender oil on pain and comfort in cardiac patients after injection of enoxaparin.

This clinical trial study was performed on 50 heart patients in Shahid Beheshti Hospital in Kashan. For collected information used a researcher-made checklist including two parts: demographic, pain scale and comfort. Patients were specified to intervention and control groups, rate of pain and comfort were measured immediately and 5 minutes after two intermittence injections with VAS visual scale. Data by using software SPSS version 16 and Statistical tests including t-test and chi-square were analyzed.

Findings showed that the two groups not differ significantly in demographic characteristics. In the intervention group in the second injection, the patient's pain was decreased immediately (P < 0.001) and 5 minutes (P < 0.001) after the first injection, also comfort level of the patients in the intervention group was significantly higher than the control group (P < 0.001).

Lavender oil has a significant effect on the pain decreasing and increasing the level comfort of patients taking enoxaparin, so it can be used to relieve pain and increase the level comfort of patients taking enoxaparin.

Multiple sclerosis (MS) is a chronic disease of central nervous system, which causes a lot of complications and problems for patients and leads to their disability and dependency in life. The aim of this study was to determine the effectiveness of self-care training program on controlling disease-related complications in women with multiple sclerosis.   In this interventional study, 70 women with multiple sclerosis were selected by simple random sampling. The selected subjects were randomly assigned to two groups of intervention and control. Data were collected using a researcher-made questionnaire and completed by structured interview. The training classes were held in two sessions for the test group and the questionnaires were completed again by both groups three months later. Data were analyzed using independent t-, paired t-, Chi-square, Fisher exact, and Mann-Whitney tests.   The mean score of self-care of the patients in the intervention group significantly increased after the intervention; so that their mean score increased from 35.42 to 59.51 (p<0.05). Moreover, Before the intervention, the mean score of muscle cramp of the intervention group, was 3.4; fatigue, 4.14; constipation, 3.17; and amnesia, 3.25; But after self-care training program, this mean decreased to 1.91, fatigue to 2.68, constipation to 1.2, and amnesia to 1.71 (p<0.05).   Reduction in MS physical complications in the intervention group, as compared to the control group, was indicative of the positive effect of the training program. Therefore, it seems that training these patients and encouraging them to perform the self-care program can have beneficial results.

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive age women. In the present study, the effect of weight loss diet and vitamin D supplementation was investigated on total testosterone, anthropometric indices, and body composition in patients PCOS. In this controlled clinical trial, 60 PCOS women with vitamin D deficiency, were randomly received vitamin D3 supplementation orally at the dose of 50000IU/week along with weight-loss intervention or one placebo/week along with weight-loss diet for 12 weeks. At the beginning and the end of the study, indices, such as anthropometric, body composition, serum level of 25-hydroxyvitamin D3, and total testosterone, were measured using parametric and non-parametric tests. After a 12-week intervention, the median of serum 25-hydroxyvitamin D3 significantly increased from 18.5 to 42.69ng/ml in vitamin D group compared to the placebo group (p<0.001). Moreover, the mean of weight, body mass index (BMI), Waist circumference, hip circumference, waist to hip ratio, and fat mass significantly decreased in both groups, but was not different between the two groups. The mean of total testosterone decreased from 0.7 to 0.5ng/ml in vitamin D group, which was not statistically significant. According to the results of this study, vitamin D supplementation in combination with low-calorie diet had no effect on total testosterone.

There are several reports regarding the beneficial effects of omega-3 fatty acids on inflammatory factors and lipid profile. However, different sources of this kind of fatty acids have not been much studied. The objective of this study was to compare the effects of consumption of walnut (plant source of omega-3 fatty acid) salmon fish (marine source of omega-3 fatty acid) and their combination on inflammatory factors and serum levels of lipids in overweight and obese women. In this clinical trial study, 99 overweight and obese women underwent three weight reducing interventions, including diets with fish (300g per week), walnut (18walnuts per week) or combination of fish and walnut (150g fish and 9walnuts per week) for 12weeks. Inflammatory factors and serum lipids were measured at baseline and the end of the study. ANCOVA test was used to analyze the data. The decrees in LDL (p=0.03), hs-CRP (p<0.01), TNF-α (p=0.01), and IL-6 (p<0.01) and increase in HDL (p<0.01) in the combination of fish and walnut group was significantly higher compared to fish group and walnut group. A decrease was also observed in triglyceride (TG) in the fish group compared to other groups (p=0.07), although this difference was not significant. Changes in weight and waist circumference in the combination of fish and walnut group was relatively significant compared to other groups. The results of this study showed that the effect of combined use of plant and marine sources of omega-3 fatty acids on the reduction of inflammatory factors and improvement of the lipid profile, is more beneficial than the separate consumption of fish or walnut.

Bleeding and pain are complications of tooth extraction, that preventive measures to reduce the severity of these complications will improve service quality and increase patient comfort. The aim of the present study was to determine the effect of Gelatamp on pain and gingival bleeding after tooth extraction.

This double blind randomized controlled clinical trial, was carried out on 71 patients referring to dentistry centers for extraction of two teeth at the same location in the maxilla or mandible. After tooth extraction, dressing was randomly performed using Gelatamp in one side and sterile gauze in another side. Bleeding and pain after tooth extraction were recorded at different times. Data were analyzed using chi square, Mann-Whitney, and Friedman statistical tests.

In this study, the mean (±SD) age of the patients was 29.29±6.01 and 52.1% of the subjects, were female. In the Gelatamp group, bleeding had stopped in the first hour in 97.2% of cases and only in 2.8% of cases, bleeding had stopped within 1-4 hours after tooth extraction. In the control group, bleeding continued in 50.7% and 49.3% of the cases, within the first hour and 1-4 hours after tooth extraction, respectively; this difference was statistically significant. The pain severity recorded at different times in the Gelatamp group, was significantly lower than the control group.

The results of this study showed that using Gelatamp in the dental cavity after tooth extraction surgery, can reduce the amount of bleeding and pain intensity.

Polycystic ovary syndrome (PCOS) is a common endocrine disorder associated with metabolic complications, which affects about 5-10% of women of reproductive age. The present study was designed with the objective of investigating the effect of selenium supplementation on lipid profile and indices of glucose and insulin metabolism in women with PCOS.
This randomized double-blind controlled clinical trial, was conducted on 70 women with PCOS (age range, 18-40years)s. The participants were randomly divided into two groups (each 35 subjects), including the group that received selenium supplementation (200µg, daily) and the group that received placebo (100mg cellulose, daily) for 8 weeks. Fasting blood samples were collected at baseline and after 8 weeks. Data was analyzed using the analysis of covariance (ANCOVA) statistical test.
Selenium supplementation significantly decreased the serum insulin level (-29.83±47.29vs .07±77.12pmol/l, p=0.013), homeostasis model of assessment-insulin resistance (HOMA-IR) (-1.15±1.81vs .42±3.09, p=0.011), homeostatic model assessment beta cell function (HOMA-B) (-19.06±30.95vs .55±47.99, p=0.017), and increased the quantitative insulin sensitivity check index (QUICKI) (.03±0.04 vs .0009±0.05, p=0.032) compared to the placebo group. In addition, serum triglyceride level (-0.14±0.55vs .11±0.30mmol/l, p=0.025) and very-low-density lipoprotein (VLDL) concentration (-0.03±0.11 vs .02±0.06 mmol/L, p=0.025) significantly decreased after the intervention.
The findings of this study revealed that daily intake of selenium supplement in women with PCOS may have beneficial effects on insulin metabolism indices, serum triglyceride level, and VLDL level

Labor pain is one of the most severe pains. Given the importance of reducing labor pain and prioritizing natural delivery, this study was performed with the objective of investigating the effect of local heat therapy on pain, delivery outcomes, and rate of satisfaction in primiparous women.
This clinical trial study was conducted on 80 primiparous women in Karaj city. The samples were selected using easy sampling and assigned to two groups, then, pain severity, delivery outcomes, and rate of satisfaction, were recorded in the two groups,. Data were analyzed using independent and dependent t-tests at the significance level of p In this study, there was a significant difference between the two groups in variables of severity of pain, mean duration of first and second stages of the labor, frequency distribution of satisfaction of the studied subjects in terms of the type of intervention, satisfaction from the delivery process, first experience of breastfeeding, and mothers’ satisfaction from embracing their newborn babies (p Based on the results of this study, it seems that control of pain and making satisfaction using noninvasive methods of local heat therapy without affecting adverse maternal and fetal outcomes, promote progression and encourage mothers for normal delivery.

Chronic viral hepatitis B is a global health problem, which, if not treated, can lead to some serious complications, such as liver cirrhosis and hepatocellular carcinoma. In this study, the effect of antiviral therapy with tenofovir, was investigated on reduction of liver fibrosis and improvement of liver function in patients with chronic hepatitis C.
In this clinical trial, 40 patients with chronic hepatitis B underwent antiviral therapy with tenofovir 300 mg daily. Demographic information and results of laboratory tests (before treatment and 6 months after the start of treatment), were collected using a checklist. Liver stiffness was measured and recorded using a fibroscan device (before and 6 months after the treatment). Data were analyzed using Wilcoxon and paired t- tests. The level of significance was considered to be p Among 40 patients, one person was excluded from the project due to lack of follow-up. Of remaining 39 patients, 27 subjects (69.2%) were male and 12 subjects (30.8%) were female. The mean age of the patients was 47.53±13.68 years. The mean levels of AST, ALT, Child score, and liver stiffness did not show significant improvement during a 6-month follow-up according to Wilcoxon and paired t- tests.
This study showed that although hepatic fibrosis and liver function in patients with chronic hepatitis B are reversible after treatment, changes require long-term treatment and follow-up.

Osteoporosis is one of the disasters of the recent century. Given the greater involvement of women in all age groups, prevention of osteoporosis is essential in women. Individual empowerment is one of the strategies to prevent the growth of osteoporosis. In this research, the role of empowerment model-based education, was investigated in the prevention of osteoporosis in female students.
In this controlled trial, the target community (before and after) included female students of Islamic Azad University, Shahrekord Branch. The sampling method was two-stage stratified random sampling and the sample size was determined (75 people for each) in intervention and control group. Data were collected using a demographic questionnaire and a researcher-made questionnaire on individual empowerment for the prevention of osteoporosis (before the intervention and 3 months after intervention). Statistical analysis was carried out by independent t-test, paired t-test and Chi-square.
In this study, there was a significant increase in the scores of the constructs of knowledge (p The results of this study showed the educational intervention based on self-empowerment model can be effective in the improvement of female students in the prevention of osteoporosis.

Irisin, as a myokine, has been known in reducing obesity and converting white to brown adipose tissue. The purpose of this study was to investigate the effect of high-intensity interval training and L-arginine supplementation on serum level of Irisin and body fat percentage in overweight and obese men.
In this randomized clinical trial, 40 young healthy overweight and obese men (mean age, 24.5±6.5 years and body mass index, 29.4± 3.6kg/m2), were randomly assigned to 4 groups of high-intensity interval training, L-arginine supplementation, high-intensity interval trainingarginine supplementation, and placebo. The training program consisted of 3 sessions/week high-speed interval running for 6 weeks. L-arginine supplement was consumed orally 6gr/day. Blood sampling and measurement of body fat percentage, was performed 24 hours before and 48 hours after training program and supplementation. Data were analyzed using ANCOVA and post-hoc Bonferroni tests (p The serum level of irisin significantly increased following 6 weeks of high-intensity interval training and high-intensity interval trainingarginine supplementation (pvalues= 0.017 and 0.019, respectively). While L-arginine consumption did not cause any significant changes in the level of irisin (p=0.19). Body fat percentage had no significant changes following 6 weeks of high-intensity training and L-arginine consumption (p>0.05).
According to the findings of this study, 6 weeks of high-intensity interval training and high-intensity interval training accompanied by L-arginine supplementation can be an effective step in facilitating the activation of brown adipose tissue through increasing the serum level of irisin. Thus, high-intensity interval training can be used as a method in the treatment of obesity.

Obesity leads to cardiovascular diseases, diabetes, and hypertension. Sleep disorder can also cause obesity and overweight through changing the levels of neuropeptides, such as ghrelin and leptin as well as other mechanisms. In the present study, the effect of vitamin D supplement, was investigated on anthropometric indices in overweight or obese individuals with sleep disorder.
In this double-blinded clinical trial study, statistical population consisted of 74 overweight or obese women and men (age, 20-50 years) with sleep disorder who referred to Golestan Hospital in Ahvaz city. The mean serum level of vitamin D in the studied subjects was less than 30ng/ml. In the treatment group, 50000 units of vitamin D was taken for 8 weeks (once per week), and in the placebo group, 4 pearls were taken for 8 weeks. Plasma level of 25(OH)D3, weight, body mass index, waist circumference, waist to hip ratio, sunlight exposure period, physical activity, and 3-day food recall, were measured at the beginning of the study and 8 weeks later.
Serum level of 25(OH)D3 significantly increased from 24.7ng/ml to 37.6ng/ml after 8 weeks of intervention in the treatment group (p The results of this study showed Vitamin D supplementation increased serum level of Vitamin D and reduced waist circumference in overweight or obese subjects suffering from sleep disorder.

Osteoporosis is a preventable disease. Insufficient knowledge is one of the major causes of high prevalence of osteoporosis. In this study, the effect of education via email, was assessed on osteoporosis-preventive behaviors among female students.
This clinical trial study (pretest, posttest and with control), was performed on 170 female students of Mazandaran University (state and non-medical university) in 2013. In this study, email was used as an educational tool to improve physical activity and calcium intake among female students. Data collection tool was a valid questionnaire consisting of 3 sections [demographic, calcium intake (FFQ), and physical activity (IPAQ)]. Emails were sent to the students during 4 weeks. Data were analyzed before and 3 months after the education using independent t-, paired t-, and Chi square tests.
The amount of calcium intake in the experimental group significantly increased after the education compared to the control group (p=0.009). Also, the score of physical activity significantly increased after education compared to the control group (p The results of this study showed that new communication technologies could be used for health education purposes. Therefore, sending emails can affect osteoporosis-preventive behaviors among adolescents, especially young women.

Randomized controlled trials often suffer from two major problems, i.e., noncompliance and missing outcomes. One potential solution to this problem is using the intention-to-treat (ITT) analysis approach. Therefore, the aim of this study was to review the concept of ITT and the most important issues related to it in practice since RCT researchers utilize it as a guide in order to improve the quality of RCT studies.
Methods & Materials: A review study was performed using available resources and comprehensive analysis. For this purpose, we searched the relevant articles in databases including Ovid/Medline, SCOPUS, Web of Science, Google scholar and Magiran. The key words that were used included randomized clinical trials, randomized controlled trials, intention-to-treat analysis, per-protocol analysis, ITT, as-treated.
The advantages of ITT, the critique of ITT, the alternatives of ITT and their limitations, missing data and their management in clinical trial studies were discussed in this paper.
ITT approach, due to its adherence to the principles of randomization, protects clinical trials from confounding and bias and therefore leads to the generation of the highest quality scientific evidence in the clinical research field. ITT should be considered a strategy at all stages of research, including the design of study, implementation and data analysis, and it should not be considered only a statistical approach.

Suction causes complications, such as tachycardia and hypertension due to stimulation of the sympathetic nervous system or complications, such as bradycardia and hypotension due to vagal nerve stimulation. The aim of the present study was to compare the effect of open endotracheal tube suction with two different sizes of suction catheter on changes of heart rate and blood pressure in patients hospitalized in intensive care unit.
This clinical trial study was performed as a pretest-posttest study using comparative intervention and random sampling. Thirty-six patients hospitalized in intensive care unit of Yasuj Shahid Beheshti Hospital underwent suction with two catheter sizes of 12 and 14. Changes in blood pressure and heart rate (before, during, and 5 and 20 minutes after the suctioning), was recorded. To compare the amount of changes in heart rate and blood pressure at different stages of suction, repeated measures ANOVAwas used.
In this study, the heart rate increased more during suction with catheter 14 compared to the catheter 12, and the difference was significant (p=0.000). Increase in heart rate up to 20 min after suction, was higher with larger catheter compared to the smaller catheter, and the difference was significant (p=0.000). Systolic blood pressure increased after suction with large catheter, and the difference was significant (p=0.050). The diastolic blood pressure had the highest increase in 5 min after the suction, but there was no significant difference between the two catheter (p=0.186).
The use of small size catheter during suction, causes less increase in heart rate and blood pressure.

Randomized Controlled Trials (RCT) are important tools for evidence based health care decisions. The aim of this study was to evaluate the quality of published randomized controlled trials in the Journal of Military Medicine and also follow the trend of changing process of the quality of the report during time.
This study is a journal based assessment. All clinical trials that had been conducted on humans and had a control group during 1999-2015 and were published in the Journal of Military Medicine were included in the current survey. For all articles, data (descriptive) such as year of publication, the university, the sample size and gender of the subjects, the scope of patients, type of outcome, trial and comparison group and the university ethics approval, was extracted. Also, the quality of each clinical trial was carried out by one assessor using CONSORT 2010 and Jadad scale. In this study, in addition to the items individually, the trend of overall score for checklist (Consort 2010) and scale (Jadad) over time (1999 to 2015) were also assessed.
Results revealed that 36 RCTs with the consideration of the study criteria (having control group, the study is conducted on humans) were published from 1999 to 2015 in the Journal of Military Medicine. As observed, in 22 (61.1%) of the studies, the first author or the corresponding author were from the Baqiyatallah University of Medical Sciences. The parameters which measured the level of physical health, knowledge and skills and readiness, pain, mental and social health outcomes were 23 (63.8 %) , 9(25 %), 2 (5.6 %) and 2 (5.6 %) reports, respectively. Also, the cover and dress, chemotherapy, other drug therapy, education, training and other interventions were 4 (11.1%), 9 (25%), 4 (11.1%), 10 (27.8%), 7 (19.4%) and 2 (5.6%), respectively. According to CONSORT checklist (7 items), the best report was related to completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed (6a). In order to survey the trend of CONSORT and Jadad during time periods, time periods were divided them into 4 categories; 2005 and before that, 2006 to 2008, 2009 to 2011 and 2012 to 2015. The changes of the CONSORT index is not significant. The average score of RCT according to the Jadad scale was 1.78±1.12 (35.55% of their maximum possible total score of scale). According to the time period categorization, the changes of the Jadad index was not significant.
Some of the weaknesses in the quality of reporting, including the method of randomization, blinding and registration of trial can be improved by using standard reporting tools (e.g. CONSORT checklist and Jadad Scale) in the process of submitting and thesis judgment, by training courses held by journal editors for researchers and also by using methodologist's consult.

In clinical conditions, it has been shown that Kinesio Taping (KT) is effective for many musculoskeletal disorders, but its effect on chronic low back pain (CLBP) has not been well studied. The purpose of this study was to compare the effects of sham and actual KT in patients with non-specific CLBP.
In this single-blind controlled clinical trial, the statistical sample size was 40 patients with non-specific CLBP. The subjects of experimental group (N=20; mean age, 48.6 years) received KT for paravertebral muscles with 10-15% tension in 8 sessions (during 4 weeks); while in control group (N=20, mean age, 50.3 years), KT was applied without tension in the same period of time. The primary variables included pain intensity and CLBP-related disability following a 4-week intervention; however, secondary variables were intensity of pain and disability, 12 weeks after the end of intervention. The data analysis was performed using descriptive statistical tests and linear analysis of variance.
In this study, KT application with tension caused no significant change in pain intensity and disability (4 weeks after intervention) (p>0.05). Also, no significant between-group difference was observed for the measured variables (p>0.05).
Based on the results of this study, application of KT with tension to generate skin convolutions was not more effective compared to its application without tension. These results may challenge the suggested mechanisms for effectiveness of KT. Therefore, further researches are required to resolve this challenge.

Pre-surgery anxiety is a common factor among the individuals referring to the operating room. The present study has been conducted with the objective of investigating the effect of lavender essential oil on the anxiety, hemodynamic changes, and pain using the aromatherapy method.
This single-blinded clinical trial study was performed on 64 patients candidate for surgery with average anxiety score (46-56). The samples were divided into two equal groups (N=32 in each group). The first group had lavender aromatherapy for 20 min and the second group had aromatherapy with distilled water for 20 min. Finally, the levels of hemodynamic changes, pain, and the state (clear) and trait (hidden) anxiety, were investigated using the Spielberger State-Trait Anxiety (STAI) questionnaire once at the night before surgery and once on the day of surgery after aromatherapy.
In this study, 30 male patients (46.9%) and 34 female patients (53.1%) with the mean age of 28.2±6.4 (minimum 17 and maximum 40 years old) were investigated. Spielberger trait mean score was not significant in control and aromatherapy group before and after the anesthesia. Spielberger state anxiety mean score in control group before and after the anesthesia was respectively obtained 52.1±1.5 and 50.2±2, which was not significantly different, but this mean in aromatherapy group before and after the anesthesia was respectively 51.9±3.8 and 45±2, the difference of which was significant (p=0.03). The mean pain score during exit from recovery in control and aromatherapy groups was, respectively, 45.3 and 29.5, the difference of which was significant (Z=-2.55, p=0.01).
Considering the reduction of pain and anxiety in the recovery before and after aromatherapy by the Lavender essential oil, especially in subjects with moderate anxiety, it seems that use of this plant before surgery is effective in the reduction of anxiety.