Effects of counseling professional ethics principles on midwifery professional codes of ethics compliance and applicability rate among midwives in community health centers: a randomized clinical trial in Iran

Introduction Compliance with ethical principles is regarded as one of the key components in providing services in midwifery profession. This study was to evaluate the effects of counseling professional ethics principles on midwifery professional codes of ethics compliance and applicability rate among midwives working in community health centers in the city of Karaj, Iran. Methods This randomized controlled trial (RCT) was conducted in 2018 on a total number of 84 eligible midwives in two intervention and control groups, selected through multistage sampling method. The intervention group took part in six counseling sessions but the control group only received a training manual. Both groups then completed the Self-Reporting Questionnaire of Ethical Codes of Reproductive Health Providers (including 95 items in 14 domains) at three time points (before, immediately, and four weeks after intervention). Finally, the data were analyzed using the IBM SPSS Statistics (version 22) software via descriptive and inferential statistics. Results The findings showed that level of compliance and applicability rate in all 14 domains of midwifery professional codes of ethics were higher in the intervention group (after intervention) than those in the control group and trend of time changes in mean level of compliance and applicability rate of codes of ethics during the three time points were significantly different between both groups (p < 0.001). Conclusion Given the effectiveness of counseling professional ethics principles on midwifery professional codes of ethics compliance and applicability rate among the midwives working in community health centers, designing and applying this counseling approach was recommended to improve quality of reproductive health care services.


Introduction
Ethics, with a long history of over 2500 years all over the world [1], refers to principles and values governing individuals and collective behaviors, and determining if something is good or bad [2]. Ethics has always been a subject of debate among scientists, philosophers, and religious scholars, so it has become more problematic to distinguish ethical considerations from unethical ones [3]. The approach of today´s world can be also seen as a return to rationality and human ethics [4]. Therefore, ethics can be considered as the center of future world developments [5]. Medical ethics is also a branch of professional ethics, accounting for ethical and specialized codes practiced by medical professionals [6]. In this respect, the concept of codes of medical ethics encompasses ethical principles including beneficence, non-maleficence, respect for autonomy, and justice. Furthermore, ethical rules contain privacy, honesty, loyalty, and respect for privacy [7]. Among various medical professions, midwifery has particular holiness and sensitivity, so it is imperative to pay attention to its ethical foundations [6]. Midwives also play important roles in counseling and educating women, families, and communities in terms of health. Furthermore, they are responsible for maintaining and promoting maternal and child health [8].
The International Confederation of Midwives (ICM) was established in 1996 with a meeting of midwives from 72 countries to achieve the goal of promoting health status of women and children and improving quality of midwifery care services. The members of the ICM have thus far worked to fulfill the stated goals in formulating midwifery codes of ethics [9]. Accordingly, the Iranian Ministry of Health and Medical Education (MHME) developed and published 85 midwifery professional codes of ethics in 6 domains based on working conditions and dominant culture in 2013 with the aim of promoting quality of midwifery care services in this country [10]. It should be noted that midwives need to be well aware of ethical and legal scopes of their duties because of the wide variety of services offered in the broad field of reproductive health [11]. A number of studies have revealed that some aspects of professional ethics have been poorly observed.
In this respect, Rahimparvar et al. (2014) found that level of compliance with professional codes of ethics in midwives in the city of Tehran was generally moderate [9]. Mosalanejad and Ghorbanifar (2013) also reported that health care staff had no good levels of compliance with ethical principles, and they had even performed poorly on commitment and secrecy [12]. Moreover, Turkmen et al. (2015) suggested that most nurses working in pediatric clinics had attempted to comply with ethical codes, but they still tended to take training courses to learn further ethical codes [13]. To improve midwifery professional codes of ethics compliance and applicability rate, it seems of utmost importance to pay further attention to training and counseling these codes [9]. Counseling as an inevitable requirement in today´s world is a process that can lead to changes in perceptions, beliefs, attitudes, behaviors, and ultimately lifestyles [14,15]. In a counseling process, counselors can thus make use a range of counseling methods (individual and group) to help clients make practical changes in different aspects of their lives and careers [16].
In this regard, Namadi et al. (2018)  Therefore, based on the existing scientific literature on midwifery professional codes of ethics as well as their sensitivity and importance in promoting this field and in order to provide better quality services to clients, this study investigated the effects of counseling professional ethics principles on midwifery professional codes of ethics compliance and applicability rate among midwives working in community health centers in the city of Karaj, Iran.

Sample selection
This randomized controlled trial (RCT) was conducted on a population of 84 midwives working in community health centers in the city of Karaj in two intervention and control groups (42 individuals in each group), enrolled from July 23 to November 21, 2018; using multistage cluster sampling method. In the first phase of the sampling, the city of Karaj was first subdivided into northern, central, and southern regions. Then, a community health center was randomly selected from each region as the intervention group, and the closest center was considered as the control one. Random numbers were then sealed in a predetermined computer-made randomization opaque envelope.
Accordingly, the participants were allocated to an intervention and a control group. The sampling was further continued to obtain the desired samples (14 in each selected region). The Consolidated Standards of Reporting Trials (CONSORT) flow diagram of the study is described in Figure 1. The samples were voluntarily enrolled on the basis of inclusion criteria i.e. a Bachelor´s degree or higher in midwifery, at least one year of work experience related to midwifery, failure to attend professional ethics-related workshops for at least six months before, and no history of referrals to the Islamic Republic of Iran Medical Council (IRIMC) and other relevant authorities to explain professional practices or to dismiss charges. The exclusion criterion was refusal to attend more than one in-person counseling session in the intervention group.

Sample size
The sample size was estimated to be 33 in each group according to the study of Rahimparvar et al. (2014) that achieved a standard deviation of 0.552 for the professional codes of ethics in total [9], assuming counseling results in a half-unit increase and equality of variances between the intervention and control groups with 99% confidence interval and 90% test power using the following equation: . n = [(0.522 2 +0.522 2 )(2.58+1.28) 2 /0.5 2 ] = 33. Considering the 20% dropout during the intervention, the final sample size was calculated by 42 in each group.

Study protocol
The intervention group was initially provided with a training manual on professional midwifery ethics, then four 60-minute sessions of group counseling in a 14-person group and two 30-minute nonattendance sessions (Telegram social media) were held on a weekly basis in coordination with members and through notifications in advance on certain days and times. The design of counseling sessions in the intervention group is described in Table 1

Measurements
The data collection instrument was a two-part questionnaire; the first part was a demographic characteristics form and the second part was a survey of midwifery professional codes of ethics compliance and applicability rate adapted from the Self-Reporting Questionnaire of Ethical Codes of Reproductive Health Providers in 20 domains, designed and evaluated by FarajKhoda et al. (2012) in the form of a PhD dissertation on reproductive health in an exploratory study, whose psychometric evaluation had shown content validity of 0.94, consensus of expert panel members by 94%, internal consistency of 86%, and stability of 95% [19]. In this study, 14 domains were evaluated in 95 items including compliance with client´s human dignity (6 items), compliance with client´s right to make decisions (11 items), obtaining client´s informed consent (4 items), disclosure to client (6 items), keeping client´s information confidential and secrecy (8 items), disclosing client´s information (6 items), compliance with client´s privacy (8 items), principle of profitability to client (6 items), no harm to client (5 items), compliance with principle of justice (5 items), service provider relationship with colleagues (5 items), service provider relationship with community (4 items), duty of service provider (14 items), and compliance with professional codes by service provider (7 items). Both qualitative and quantitative methods were also used to assess the content validity of the questionnaire. To do so qualitatively, 10 professionals in reproductive health and professional ethics across Iran were asked to submit their correctional views in writing after careful study of the tool. After collecting expert opinions, necessary revisions in the questionnaire were considered. As well, quantitative content validity showed that all the items had a minimum content validity ratio (CVR), based on the Lawshe table (0.62), and all the items scored above content validity index (CVI) of 0.79, thereby indicating appropriateness. The reliability of the research instrument was also assessed using intracluster correlation coefficient (ICC), which was 0.87, indicating an acceptable consistency of the questionnaire. A 5-point Likert-type scale was also employed to measure the compliance of each ethical item (i.e. very low=1, low=2, moderate=3, high=4, and very high=5 levels of compliance). The applicability rate of each item was additionally measured using the same questionnaire and scale.

Statistical methods
The data were analyzed using the IBM SPSS Statistics (version 22) software via descriptive and inferential statistics. The Kolmogorov-Smirnov (K-S) test was also performed to examine the normality of the data. Parametric (repeated measures analysis of variance (ANOVA)) and non-parametric tests (generalized estimating equation (GEE)) were further used for data with normal and non-normal distribution; respectively. Chi-square test and/or independence t-test were also applied to investigate the correlation between two qualitative variables or grouped quantitative variables. Moreover, p<0.05 was considered as the significance level. Statistical analysis was carried out with an intention-to-treat (ITT) approach as emphasized by the CONSORT statement. To improve the reporting of the quality of trials, this statement declares that the number of participants in each group must be analyzed based on ITT principles [20].

Ethical considerations
The

Results
In terms of demographic characteristics, the largest age group in both however, there was a statistically significant post-intervention difference between the study groups (p < 0.05) ( Table 2, Table 3).
Furthermore, the results demonstrated that compliance and applicability rate in all 14 domains of midwifery professional codes of ethics were higher in the intervention group compared with the control one ( Table 4, Table 5). As well, the findings of the statistical tests revealed that the trend of time changes in the mean compliance and applicability rate for the codes of all ethical domains during the three time points were significantly different between the two groups, and the highest level of compliance and applicability rate with the codes in both groups was related to the second time point (that is, immediately after the intervention).

Discussion
The results of the present study established that counseling

Competing interests
The authors declare no competing interests.

Authors' contributions
SSH was involved in the conception of the study and data collection. ZMT contributed to the study design, oversaw the whole study process, conducted data interpretation, and revised the manuscript.
All the authors read and approved the final manuscript.

Acknowledgments
The authors would like to give special thanks to the Vice-Chancellor´s Office for Research at Alborz University of Medical Sciences for funding the study. The authors are also thankful to all midwifery staff working in community health centers in the city of Karaj for the completion of the questionnaires. Table 1: content of counseling sessions for intervention group      Non-attendance Uploading educational videos on importance of familiarity with codes of ethics in medical fields, uploading text files on 85 midwifery professional codes of ethics on the Telegram channel and requesting members by the channel administrator to see and study the content and ask any questions in case of ambiguities 3

Tables and figure
Attendance Education, counseling, group discussions, and role-plays in the first seven domains of the questionnaire of ethical codes of reproductive health providers used in this study 4 Attendance Education, counseling, group discussions, and role-plays in the second seven domains of questionnaire of ethical codes of reproductive health providers used in this study 5 Non-attendance Uploading scenarios related to 14 domains mentioned in the third and fourth sessions on the Telegram channel and asking members to leave their comments on the administrator page via announcing the number of each scenario 6 Attendance Conducting a group discussion on scenarios presented in the fifth session, summarizing importance of compliance with midwifery professional codes of ethics and its impact on quality of services provided to clients, answering members´ questions, completing the second-stage questionnaire at the end of the session, appreciating participants and presenting gifts to them