Introduction
Informed consent (IC) is an ethical and legal requirement for any therapeutic intervention and the patient should be informed about all aspects of the treatment [1]. Although IC is a crucial issue during medical procedures, the process and its content are very challenging. Physicians often believe that IC is just a formal act in which the patient’s signature is obtained,  regardless of whether they have received sufficient information [2]. To obtain IC, individuals should be informed about the risks, benefits, and alternatives to the treatment method and make free and voluntary decisions. IC is a process by which the doctor interacts with the patient and enables them to make a knowledgeable decision about the treatment option. IC includes the form that patients have to read and sign. Meanwhile, the oral communication helps doctors build a stronger relationship with the patients, which some researchers believe is a prerequisite for making rational decisions [3, 4, 5, 6]. Through appropriate communication, a trained and skilled doctor can help patients determine the best treatment option, and improve their health status; also, the patient’s rights and independence are respected within a relationship based on trust. Studies have demonstrated a significant relationship between a qualified IC and better clinical outcomes and patient satisfaction. Additionally, IC reduces the risk of litigation against physicians [7, 8, 9, 10].
Despite the importance of this issue, related studies are limited in our country. Considering different cultures and beliefs, study results cannot be generalized to other areas. Accordingly, this subject was investigated in Alzahra Hospital as an academic and referral center for all types of gynecological and obstetric surgeries. This study aims to investigate the quality of obtaining IC for spinal anesthesia (SA) as a common anesthesia method in this medical center. It should be noted that patient dissatisfaction with the procedure is considered as an absolute contraindication of SA.
Methods
After the approval of the Vice-Chancellor for Research and Technology of Guilan University of Medical Sciences, this cross-sectional analytical study was performed in Al-Zahra Teaching Hospital in 2021.
The inclusion criteria comprised the following items: patients over the age of 18 years who were candidates for elective gynecological surgeries under SA, providing IC, having no cognitive impairment, able to communicate properly, and having a stable hemodynamic status.
The exclusion criteria comprised the following items: having difficulty in answering the questions because of lingual differences, having any congenital, psychological, or behavioral problems, having emergency surgeries, having unstable hemodynamic parameters, change of anesthesia technique to general anesthesia, and having the need to transfer the patient to the intensive care unit at the end of surgery. 
A questionnaire containing demographic data and 20 specific questions divided into 4 areas (9 questions about providing information, 2 questions about comprehensibility of the consent form, 4 questions about voluntary informed consent and interaction, and 5 questions about communication with the doctor) was filled out via a direct interview. The mean scores below 25% of the total were considered poor, 25% to 50% were average, 50% to 75% were good, and equal to or higher than 75% were excellent.
Results
The data of 259 patients with a mean age of 31.72±6.71 years were analyzed. The majority of the patients (57.1%) were over 30 years old. In addition, 93.4% were candidates for cesarean section. 
In terms of providing information to the patient, comprehensibility of the consent form, and voluntary obtaining consent a poor situation was reported at 95.4%, 91.5%, and 98.1% respectively. However, in terms of communication with the physician, 46.3% of the patients were in a good state and 20.1% were in an excellent state. Regarding the relationship between age (P=0.857), education (P=0.034), and type of surgery (P=0.7) with the quality of IC, only a statistically significant relationship between the level of education and the quality of informed consent was observed. In the aspect of the level of education, in all patients at any level of education, satisfaction with the communication with the doctors was recognized. However, a significant difference was observed among the classified groups (P=0.004).
Discussion
The results of this study showed acceptable scores only in the field of communication with the physician. Other areas, such as providing information to the patient, comprehensibility, and voluntary consent were in poor condition. This study revealed that the quality of the IC process in this academic center was far from the optimal situation and needs to be improved. The content of IC forms has always been a complex issue. Anesthesia methods are different from surgical methods in terms of nature and potential risks. Therefore, it is wise to design an IC containing risks, benefits, and alternatives for anesthesia procedures [11]. One of the fundamental aspects of IC is to provide sufficient information to the patient. Failure to receive adequate information results in the patient’s litigation against the physician [12]. 
Understanding the consent form is another influential component of IC. Therefore, the importance of physicians’ awareness of patients’ education level and providing information based on the patient’s understanding, and ensuring the understanding of the provided information by asking questions of the patient and answering their questions are emphasized [13]. Voluntary consent is another area of IC. Accordingly, the patient’s choice and decision should be informed freely and based on the received comprehensive information. The patient’s feeling of compulsion can be a moral barrier to conscious consent because one of the principles of conscious consent is the patient’s understanding and agreement on treatment [14]. IC is one of the basic and essential rights of patients [12]. Therefore, IC is an ethical and legal process aimed at promoting patient health and respecting their independence [14, 15]. As a result, it is recommended that the methods, diagnostic and therapeutic benefits, side effects, nature of the disease, and prognosis be provided to the patient along with any information required in the decision-making process. Information should be provided at the right time, in the patient’s best conditions in a stress-free situation, and according to the patient’s characteristics, such as language, education, and ability to understand.
In our experience, it was concluded that the IC process did not provide adequate decision-making tools to the patients while patients’ communication with the physician was well scored. Great attempts should be made and practical and effective programs should be considered for this purpose. One of the essential interventions should be adding educational courses to medical education curriculums. Furthermore, to improve physicians’ interactive communication skills all levels, including graduate physicians, must participate in these medical training programs.

Ethical Considerations
Compliance with ethical guidelines
This study was approved by the Ethics Committee of the Guilan University of Medical Sciences (Ethics Code: IR.GUMS.REC.1400.301). All ethical principles were considered in this research. The participants were aware of the research process and their information was kept confidential.

Funding
This study was supported by the Deputy for Research and Technology of Guilan University of Medical Sciences.

Authors' contributions
Study concept and design: Gelareh Biazar and Abbas Sedighinejad; Data acquisition, analysis, and interpretation: Sarina rajaei and Samaneh Ghazanfar Tehran; Drafting of the manuscript: Gelareh Biazar and Mahin Tayefeh Ashrafiyeh; Statistical analysis: Zahra Atrkarroushan and Samaneh Ghazanfar Tehran; Editing & Review: Mohadese Ahmadi and Mahin Tayefeh Ashrafiyeh; Investigation and Resources: Bahram Naderi Nabi, Atoosa Etezadi and Mohadese Ahmadi; Study supervision: Abbas Sedighinejad and Bahram Naderi Nabi.

Conflicts of interest
The authors declare no conflict of interest.

Acknowledgements
The authors would like to thank the personnel of the Anesthesiology Research Center of Guilan University of Medical Sciences for their collaboration in this study.


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