Assessment of work-related stress and burnout among clinical research occupations

Statistical analysis

Sociodemographic aspects were expressed as frequencies and percentages. Age was recorded considering intervals of < 30 years; 30 to 39 years; 40 to 49 years; 50 to 59 years; and 60 to 80 years (age intervals of the National Vaccination Plan in Mexico). For both types of surveys, normality was assessed using the Shapiro-Wilk test and equality of variances using the Levene test. Sample comparisons were performed using the Mann-Whitney U test for nonparametric data or the t test for parametric data. In comparisons where the sample size was greater than 20, Cohen’s d was used, and when the sample size was less than 20, Hedges’ h was used. In the present study, only stressors with medium to large effects and a significance level ≤0.05% were considered.

Statistical analysis was performed with the IBM SPSS statistical package (version 26, IBM Corporation, Armonk, NY, USA).

Ethical approval

The study was conducted in accordance with the General Law for the Protection of Personal Data. Ethical approval was granted by the Research Ethics Committee of Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V. (Folio number: CEI:000001) on December 8 of 2022. The surveys are carried out continuously in the company as part of an internal programme, and ethical approval was sought retrospectively when the authors decided to publish the results. After a complete description of the study to the participants, written informed consent was obtained. The confidentiality of the participants was guaranteed.

Sociodemographic aspects

The organization consists of healthcare professionals such as nurses, lab technicians, receptionists, managers, and general practitioners, in addition to personnel who support the development of clinical research, marketing, among others. In the present study, 80 people were contacted to participate, of which 79 participated and completed both surveys. Table 1 describes the number of employees by occupation, all employees who participated in the study and those who participated in both surveys (Flores Luna et al., 2023).

During the coronavirus disease 2019 (COVID-19) pandemic, personnel working in this area had variable schedules due to the high demand for COVID tests. The administrative area includes managers, assistants and receptionists who manage the company’s objectives, paperwork and the logistics of company events. Clinical operations, on the other hand, focus on managing the execution of clinical research projects for the pharmaceutical industry and are composed of nurses, clinical research coordinators, pharmacists, specialists, and general managers.

The sample included 53 women and 26 men, so the sample was mainly represented by women, which may establish a bias in the results. In terms of age, most respondents were under 30 years of age, single, childless, and the most represented occupation corresponded to clinical operations (28%); in this occupation, the main activities were focused on conducting clinical studies sponsored by the pharmaceutical industry, followed by administration and medical services (Table 1), all persons participating in the study. Note that the number of people per occupation is not the same, which may represent a bias in the results.

Work stress

Job Stress Severity (JS-S)

When evaluating the effect of stress severity among all occupations, it was possible to establish that of the 30 stressful situations, 5 showed significant results (Table 2). These are the main causes of stress common to all occupations recorded. According to Santos et al. (2011), the predominant items are part of the subscales of work pressure (4th), lack of support (10th, 17th) and lack of organization (30th).

Although the overall severity effect was medium, we continued with the particular evaluation of the JS-S scale in each of the occupations, finding significant results with large effects, mainly in the occupations of medical services with 10 stressful situations (items 1, 2, 3, 6, 11, 13, 17, 21, 27 and 30) and administration with 7 (2, 5, 7, 16, 20, 26, 29). For both occupations, most of the items are associated with the subscale lack of organization, in addition to intense work pressure, predominating in administration (Santos et al., 2011). Both occupations had in common the stressful situation of performing work in free time. On the other hand, clinical operations, financial and commercial presented large effects with 2 (item 4 and 10), 1 (item 10) and 1 (item 11) stressful situations, respectively (data not shown).

Frequency of occupational stress (JS-F). The survey revealed that the most frequent stressful situation is related to insufficient salary, although the effect was medium (Table 3). When analyzing the occupation of medical services and administration, it was observed that the items with large effect that were most frequently reported were 2b (I have to do work in my free time), 16b (In critical situations, decisions are made without careful analysis), 20b (Poorly motivated peers), 26b (Excessive compliance goals) and 29b (Poorly motivated peers). The most predominant items were associated with the lack of organization subscale (Santos et al., 2011).

Work Stress Index (JS-X). The results of the general work stress index (JS-X) indicate a moderate level of stress across all occupations, with a Cohen’s d of 0.46 and Hedges’ g of 0.47.

In the stress survey, the reliability values of Cronbach’s α coefficients were above 0.85 (JS-S: 0.97, JS-F 0.94 and JS-X: 0.97), so they can be rated as very satisfactory; thus, the results are compatible with the theoretical frame of reference (Holmström et al., 2008).

Burnout syndrome

The global average burnout shows a low trend of exhaustion (DP: 4.3; PA: 42.8; EE: 18.5), however, the global results of the emotional exhaustion scale (EE: 18.5) provided evidence of an onset of a moderate burnout syndrome among all the occupations evaluated. When performing the correlation analysis, the EE scale presented a strong positive correlation with the general result of burnout, regardless of the type of occupation (Table 4). For the PA scale, despite not being significant, a negative relationship was found with respect to burnout (r = -0.034, p = 0.768), which is consistent with other studies where it is established that this response is strongly determined by organizational processes and structures (Piko, 2006).

Similarly, it is observed in the scatter diagrams, where the high positive correlation between the EE scale and burnout is evident, and in the case of the DP scale, despite presenting a low R² value (0.608), it can also indicate its influence in the burnout response (Figure 1).

Figure 1. Data scatter diagrams for each of the scales (DP, EE and PA) as a function of the overall Burnout response.

Abbreviation: A: PD – Burnout ratio; B: EE-Burnout relationship and C: PA-Burnout relationship. R²: coefficient of determination. The 2 confidence bands simultaneously at 95%.

In Figure 2 we show the relationship between the scales (EE, PA and DP) and the occupations, confirming that the medical services personnel present a response of exhaustion associated with only two (EE and DP) of the 3 scales (Figure 2). West et al. (2009), mention that high values of depersonalization (DP) and emotional exhaustion (EE) and low values of personal accomplishment (PA) indicate exhaustion; however, in the present study, the PA scale for medical services did not show a high value of burnout.

Figure 2. Bar graphs relating each of the scales (EE, PA and DP) to the level of burnout among all occupations.

Abbreviations: Mk: Marketing; A: Administration; T: Trade; F: Finance; Co: Clinical Operations; Ms: Medical Services; O: Others.

In addition, people working in the marketing area presented a high level of burnout associated with the PA scale; it should be noted that the PA score is inversely proportional to the degree of burnout, i.e., the lower the performance or personal accomplishment score, the more affected the person is (González and De la Gándara, 2004). Job satisfaction has an important influence on work-related behaviors such as absenteeism, job performance and turnover intention (Piko, 2006). Other areas that registered moderate burnout scores were finance and clinical operations.

Shbeer and Ageel (2022) mention that the main cause of emotional exhaustion (EE) among medical services personnel is related to the nature of their tasks; in this sense, it states that workload, insufficient rewards in the workplace and unfair treatment with employees are the causes associated with EE. Chatterjee et al. (2021); mention in their study on stress in medical service personnel, that physicians tend to present high levels of anxiety due to stress, unlike nurses who develop more irritability; in general, they state that work overload leads to irritability. Piko (2006), suggests that an additional indicator to the burnout and stress survey may be the assessment of psychosomatic symptoms, which have been related to work stress and burnout.

The lack of evaluation of work stress or the presence of burnout and not having preventive programs can have repercussions on physical, emotional and psychological integrity (Corona et al., 2022) in addition to impacting work efficiency and reducing productivity in the company (Selmanovic et al., 2011).

Prevention activities to reduce stress and the incidence of burnout for workers not only in the medical services sector (Yadav & Sahu, 2022), but also for those who show signs of chronic stress or moderate burnout, contribute to the reorientation of organizational approaches; these activities include modifications of schedules, work processes, and generation of individual-centered strategies (Liebenberg et al., 2018). Shbeer and Ageel (2022) suggest taking breaks, physical activity and medical services promotion programs, to reduce burnout.

The results of this study allowed the managers of the company where the participants work to support the development of a psychosocial factors prevention plan referred to in the Mexican Official Standard NOM-035-STPS-2018; it included a detailed study of the medical services shift schedules, the creation of integration activities such as: monthly birthday celebrations, active breaks once a week and the teamwork model with dynamics focused on the needs of the community. The company also organizes talks to raise awareness about people with disabilities and against violence. In addition, the quality management system was established, which harmonized the company’s processes and procedures and promoted the development of job descriptions for personnel. These findings highlight the importance of evaluating and implementing customized strategies to overcome stress and burnout syndrome in specific functional areas within organizations. Such an approach can help to localize the main areas where employees are most affected and to tailor interventions that address the unique challenges faced by employees in different roles (Kim & Hye-Sun, 2022; Panigrahi, 2016; Salama et al., 2022).