| Summary: | 碩士 === 國立臺灣大學 === 護理學研究所 === 107 === Background
Clinical trials establish the effectiveness of new treatment for diseases to enrich human’s well-being. According to the Ministry of Health and Welfare’s annual reports, the number of clinical trials in Taiwan has increased from 119 in 2004 to 298 in 2017 and the figures are still increasing. Previous studies have proved clinical research nurses (CRNs) play a vital and active role in excellence and the quality of clinical trials. To understand the professional role performance and responsibility increases its importance. Self-efficacy is highly associated with work performance and quality of professional role because it can impact on people’s motivation, perseverance, and resilience. Self-efficacy has been identified as the foundation of behavioral motivation, psychological well-being, and personal achievement as well as the key of professional executives and quality of performance. Self-efficacy, however, can be affected by one’s personality traits and physical and mental health status. There is limited information regarding the CRNs’ self-efficacy of professional roles and performance in Taiwan. This research aimed to (1) compare background characteristics, personality trait, mental health between CRNs and Registered Nurses (RNs); and (2) explore the associations among self-efficacy of professional role and performance, personality traits, mental health status, and background characteristics.
Method
A cross-sectional study with snowball sampling was conducted in hospitals, contract research organization, site management organization, and pharmapeutical company in Taiwan. The CRNs and RNs were asked to complete either hard-copy or electronic questionnaire anonymously. This structured questionnaire comprised the role responsibilities of CRNs, Chinese Health Questionnaire, Eysenck Personality Questionnaire-Revised Short, and background information.
Results
A total of 134 CRNs and 104 RNs were recruited. The CRNs were 5 years older and more married, and higher educated than their RNs counterparts. CRNs were experienced in clinical trials with averaged 5.3 years experiences, 70% involving in 4 or more trials. The CRNs’ reported to have higher quality of sleep and life than did RNs. There is no significant difference between two groups in their resignation in the coming year. For both groups, the possibility of transferring to other institute with the same job type was about 40% and the possibility of changing departments in the same institute or leaving nursing profession were all around 20%. There was 50.8% in CRNs and 65.4% in RNs not to be considered as mentally well-being. As for the personality, there was also a significant difference in neuroticism between CRNs (score=4.6±3.1) and RNs (score=5.6±3.3) (T-test=2.478, p=.014) but not in extraversion. The CRNs rated their self-efficacy on professional role and performance: protection of study subjects (2.77±0.67), clinical care of study subjects (2.77±0.65), coordination and management of clinical trials (2.75±0.67), advanced nursing competency (2.09±0.76).
We further analyzed the factors related to high self-efficacy in the CRNs by using stepwise multiple logistic regression. The results indicated the experiences of involving in the clinical trials (adjusted Odd Ratio (aOR)=4.13，95%CI=1.89-9.02), perceived quality of sleep in past two weeks (aOR=3.04，95%CI=1.40-6.61), high possibility of transferring to new institute with same work type (aOR=2.83，95%CI=1.30-6.14) were 3 significant factors. On the other hand, by using multivariate stepwise linear regression analysis found experiences of involving in the clinical trials(β=2.292, p<0.001), educational level(β=9.112, p=0.021), common mental disorder(β=-2.249, p=0.016), and the possibility of leaving nursing profession (β=0.150, p=0.029) were significant factors related to the CRN’s high self-efficacy.
Conclusion
Overall, this research results showed the CRNs were older, more married, with higher education, better quality of sleep and life, less mental symptoms, and lower neuroticism trait than their RNs counterparts. In order to enhance CRNs’ self-efficacy of professional role and work performance, more professional training and educational opportunities are required. Furthermore, it is suggested to continually improve sleep quality, work stability and promotion opportunity for CRNs.
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