@2024 Afarand., IRAN

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ISSN: 2252-0805    The Horizon of Medical Sciences 2018;24(1):23-28

Background
Annually, tens of millions of patients in the world undergo surgery. Surgery is a stress that induces endocrine and psychological responses (anxiety and fear) [1, 2].
Previous Studies
… [3-15]. Currently, Benzodiazepines are among the most commonly use precursors, and diazepam is one of the most widely used medicines and can be ingested or orally be used [16]. … [17]. Some medical herbs have anti-anxiety and sedation properties and are used to reduce anxiety before surgery [18]. Saffaran (Crocus Sativus. L) is one of the most widely used Iranian native herb. Saffron in addition to being a high-consumption food additive, has several pharmacological effects and is considered a potential drug [19-24]. … [25, 26]. Akhundzadeh et al. investigated the effect of saffron extract with imipramine as a common anti-depressant drug in the treatment of mild to moderate depression. The result of this study showed that saffron extract has the same efficacy of imipramine without its side effects [27]. The effects of safranal agonist on the AGABA receptor complex of benzodiazepine and opioid receptor have been shown in previous studies [28].
Aim(s)
Considering the native nature of saffron in Iran and, on the other hand, the anxiolytic and sedative effects of this plant, the aim of this study was to compare the effect of safranal consumption (Saffron) and diazepam tablets on anxiety reduction and improvement of vital signs before surgery in patients undergoing surgery urology (varicocele).
Research type
The present study is a double blind randomized clinical trial.
Research society, place and time
This research was conducted among patients undergoing urological surgery (varicocele) in 15 Khordad Hospital in Gonabad city in 2013.
Sampling method and number
At first, 70 patients candidate for urology surgery were evaluated using purposive sampling. Of the 70 patients evaluated, 16 were excluded of which 5 did not have entry criteria and 2 refused to participate in the study. During the allocation period to the control group (diazepam) and intervention (Safranal), one in the intervention group and 2 in the control group were excluded from the study due to cancellation of surgery. In the follow-up phase, no patient was eliminated. Eventually, 4 patient from the control group and 2 patients from the intervention group were excluded from the research due to incomplete completion of the questionnaire. Finally, 54 patients were left and randomly assigned to two intervention (29) and control (25) groups. The random number table and the assignment of each row to study groups were only informed by informed anesthesiologist and the interviewer nurse, and the patients did not know about their group and type of drug. The researchers had the related tables and the researchers were not aware of the type of drug used before being assigned to patients under study. The sample size was calculated according to previous studies [29] and based on the formula for comparing mean with 95% confidence level and 80% test power, for each group, 20 was obtained that 25 individuals were considered for probability drop. Criteria for entering the study included willingness to participate in the study, candidate for varicocele surgery, inclusion in class 1 and 2 of the American Society of Anesthesiology, aged 18-50, being male, lack of susceptibility to saffron and its compounds, and lack of receiving sedative drugs with the exception of medication under the investigation.
Used devices&materials
After obtaining the approval of the Ethics Committee of the Gonabad University of Medical Sciences, the research was registered at IRCT at IRCT201304255445N4. The Spielberger Anxiety Inventory (STAI) was used to collect data [30]. At the beginning of the study, all patients were examined by anesthesiologist and a urological surgeon, and all the preoperative measures were taken for patients. Prior to administering the drug, all patients were evaluated for clinical signs (heart rate and blood pressure) and anxiety was evaluated by Spielberger`s questionnaire by a trained nurse. The pharmacist produced 70 similar capsules, and capsules containing 500 mg of powdered sugar were selected. For the intervention group, each capsule contained 15 mg of safranal (Sigma, USA) and 485 mg of flour, and for the control group, each capsule contained 5 mg of oral diazepam with 495 mg of powdered sugar. The contents of the capsule were only known to the pharmacist and the capsules were placed in envelopes and encoded. The envelope codes were recorded at the top of the patients` questionnaire by the nurse who was not aware of the content, and was given to a statistician at the statistical analysis stage. The diazepam group received 5 mg oral diazepam (control), 3 hours before surgery with 100 ml of water, and the safranal group (intervention) received 15 mg of safranal, 3 hours before surgery plus 100 ml of water. At the entrance to the operating room, the Spielbergeer anxiety inventory was completed by patients. Patient autobiography data was recorded before intervention. During the study, patients were evaluated in terms of side effects of both drugs. Finally, the patients were compared in terms of the level of anxiety and vital signs in the two groups and the patients who did not complete the questionnaire were completely excluded. Data analysis was done using SPSS 11.5 software. Chi-square test was used to examine the history of surgery, level of education and occupation in the two groups. Independent T test was used to compare the mean age of the participants, compare the mean of anxiety score, and compare the mean of blood pressure and heart rate in the two groups.
Findings by Text
The mean age of the research units in the diazepam and safranal groups were 31.72±8.94 and 30.76±6.51 years respectively that both groups were homogeneous in this regard. There was no significant difference between the two groups regarding the level of education, type of occupation and history of surgery (p>0.05; Table 1).Before intervention, there was no significant difference between the two groups in terms of covert anxiety (trait anxiety) and overt anxiety (state anxiety) and anxiety was mild. After the intervention, there was a significant difference between the covert anxiety scores of the safranal group and diazepam group and the anxiety of the safranal group was decreased from mild level (before intervention) to zero level after the intervention. The covert anxiety scores in the diazepam group increased after the intervention compared to the pre-intervention stage, but significantly decreased in the safranal group (p=0.002; Table 2).After intervention, diastolic blood pressure in the safranal group was significantly lower than that of diazepam (p=0.049). However, there was no significant difference between heart rate and systolic blood pressure between the two groups (p>0.05; Table 3).
Main comparison to the similar studies
… [31-34].Various studies have been done on saffron and its effects on depression, including Shahmansouri et al. who compared short-term treatment with saffron capsule (30 mg daily for 6 weeks) and floccitin tablets (4 mg daily for 6 weeks), and saffron showed the same effect of antidepressant Fluccitin in patients [35]. … [36].In the research of Basirimoghadam et al., The anti-anxiety effect of 25 mg of dried extract of saffron was compared with diazepam 5 mg to reduction of preoperative anxiety. The results showed that dry extract of saffron had more anti-anxiety effects than diazepam and the mean of anxiety was significantly lower in saffron group (p=0.007).In that research, also, the Spielberger questionnaire was used to assess the severity of anxiety and patients completed the questionnaire 3 hours before surgery (before taking the medication) [29] which was consistent with the results of the present study (reducing the mean anxiety in patients, especially the hidden anxiety), and in fact, it can be concluded that safranal in dry extract of saffron has anti-anxiety effects. … [37-39].
Suggestions
It is suggested that a study be conducted to evaluate the effects of safranal in patients with high blood pressure.
Limitations
The most important limitation of the present study was the difference in the price of safranal with diazepam.
Conclusions
Saffranal consumption before surgery is more effective than diazepam in reducing the patients` covert anxiety in patients undergoing surgery (varicocele), but it does not affect overt anxiety. Also, safranal consumption leads to a reduction in diastolic blood pressure, compared to diazepam while it does not affect systolic blood pressure and heart rate.
Acknowledgments
The present study was supported by the Deputy Director of Research and Technology of the Army University of Medical Sciences of the Islamic Republic of Iran (AJA). The expert of elite affairs, the University’s Research Council, deputy research associate and research affairs manager are appreciated. Dear staff members of the Department of Anesthesiology, operating room of the 15th Khordad Bayadokh Hospital in Gonabad city, and patients who helped us with this study, are appreciated.
Conflict of interest
Non-declared
Ethical Permissions
This research was approved by the code A K/1/2/92 at the Ethics Committee of Gonabad University of Medical Sciences. Also, it has been registered in the clinical trial registration database IRCT201304255445N4.
Funding Sources
This research is the result of a collaborative research work between the Aja University of Medical Sciences and Gonabad University of Medical Sciences and has financial support from the Deputy of Research in both university.

TABLES and CHARTS

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