臨床研究護理師工作壓力與身心健康之相關性

Work Related Stress and Well-Being among Clinical Research Nurses

范育瑄(Yu-Hsuan Fan)

指導教授 ： 張榮珍

國立臺灣大學/醫學院/護理學研究所/碩士(2020年)

https://doi.org/10.6342/NTU202002097

摘要

【背景】
臨床試驗是新藥發展不可或缺的一部分，隨著醫療科技的進步，人口高齡化加劇，醫藥需求增加，全球藥品研發市場持續穩定增長，臨床試驗複雜度日益增進，因此業界與醫療機構(site)對臨床研究護理師(clinical research nurses, CRNs)的人才需求也不斷地提升。臺灣臨床試驗發展已逐步邁向國際水準，而臺灣雖近年來臨床試驗案件蓬勃發展，也受到國際肯定，CRNs的需求持續增加且工作挑戰持續增加，卻少有探討CRNs相關工作壓力與身心健康之研究，因此本研究主要探討CRNs工作壓力現況與相關因素，包含CRNs性格特質、身心健康、工作情境感受等，期能提高對CRNs職業壓力相關因素的重視與了解，持續改善CRNs專業執業環境的困境，以提升我國在臨床試驗國際舞台的競爭力。
【方法】
本研究為採橫斷式研究，以紙本與線上問卷兩種方法進行資料收集，以滾雪球方式在2020年4月至7月期間於台灣北、中、南各臨床試驗醫院、臨床試驗機構管理公司(Site Management Organization,SMO)、臨床試驗委辦公司(Contract Research Organization, CRO)邀請CRNs填答問卷。問卷包括基本屬性、臨床研究護理師壓力源量表(Stressor Scale for Clinical Research Coordinator, SSCRC)、華人健康量表與簡式性格量表。所得資料以統計軟體 SPSS 22.0版進行描述性及推論性統計分析。
【結果】
本研究有效問卷193份（有效反應率96.5%）。研究發現：(1)中文版SSCRC量表具良好信效度(Cronbach’s Alpha=0.917，CVI為0.83以上)(2)CRNs工作壓力來源在SSCRC量表六面向中，以「工作負荷」與「模糊不清的工作項目」兩層面壓力最高，而最高的單項壓力則是「工作角色太廣泛」、「很多工作要完成」及「執行臨床試驗時沒有充分權限」。CRNs感受工作情境壓力高的為「臨床試驗執行過程發生試驗偏差(protocol deviation)」、「臨床試驗設計與執行越來越複雜」及「研究團隊成員流動高」。(3)多元線性迴歸分析發現CRNs工作壓力高與「焦慮憂鬱」、「工作情境壓力」、「神經質性格」、「睡眠品質」及「臨床試驗為腫瘤或血液腫瘤科別」成顯著正相關；而與「薪資滿意度」及「生活品質」則是存在顯著負相關，另外本研究也發現(4)「近兩週睡眠品質」、「未來一年續任率」、「臨床護理師年資」及「CRN工作壓力」為CRN生活品質重要的影響因素。
【結論】
本研究顯示中文版臨床研究護理師壓力源量表具有極佳信效度，適用於台灣本圖研究。CRNs身心健康確實與工作壓力有顯著相關，而神經質性格、癌症科別臨床試驗及薪資福利滿意度也都是CRNs工作壓力重要關鍵因素，未來改善CRNs職場壓力可從上述各面向進行強化。CRNs工作負荷大與角色職責模糊是兩大重要壓力源，未來CRNs教育訓練的重要主題可針對處理試驗偏差以及複雜的臨床試驗研究設計，期待政府與試驗機構與雇主能持續改善CRNs工作量、明定專業角色內涵及發展CRNs專業訓練策略，這些努力將對台灣投身國際化臨床試驗品質提升與受試者安全保障具重要影響。

關鍵字

臨床試驗 ； 臨床研究護理師 ； 工作壓力 ； 神經質 ； 身心健康 ； 生活品質

並列摘要

Background
Clinical trials are indispensable in the development of new drugs. With the advancement of medical technology and the aging population, the demand for new drugs has increased. The global market of pharmaceutical research and new drugs development has grown steadily. The demand for clinical research nurses (CRNs) has been continueously increased due to the designs of clinical trials become gradually complex. The developments of clinical trials in Taiwan gradually achieve global recognition and thus the demand for CRNs grows as well as the complexity of trials intensifies. However, limited attention has been given to exploring the relationship between the work-related stress of CRNs and their well-being. The purpose of the study was to explore the relationship between work-related stress, personality trait, and mental health. It is hope to improve the understanding and attention for CRNs’ work-related stress, to get the CRNs out the dilemma from adverse conditions so as to boost Taiwan's competitiveness in the international stage of clinical trials.
Method
A cross-sectional design was applied in this study. The clinical research nurses (CRNs) were recruited by snowball sampling from hospitals, Site Management Organizations(SMO), and Contract Research Organizations(CRO) in Taiwan from April to July 2020. The online and paper-pencil measurement tools consisted of a basic demographic information questionnaire, the Chinese version of the Stressor Scale for Clinical Research Coordinator (SSCRC), 12-item Chinese Health Questionnaire (CHQ-12), and Maudsley Personality Inventory (MPI). The SPSS 22.0 statistics software was applied to process and analyze study data.

Result
A total of 193 valid questionnaires were analyzed at a responding rate of 96.5%. The major findings of this study includedthe followings. (1) the Chinese version of the SSCRC had satisfactory reliability and validity (Cronbach’s Alpha=0.917 and CVI≧0.83). (2) The work-related stress were from “Quantitative workload” and "Ambiguity of work". The highest stressful items rated by CRNs were "Q4.My role is too broad", "Q2.There is a great deal of work to be done," and “Q14.I do not have sufficient authority to perform clinical trials". Notably, "protocol deviation", "more complex design for clinical trials", and "the high turnover of research team members" were the highest stressful situations in the CRNs' work environments; (3) The multiple linear regression model indicated that "mental distress,” “work-related stressful situations,” “neuroticism trait,” “quality of sleep,” and “clinical trials in oncology or hematology” were positively associated with high stress scores and "satisfactory salary and benefits" and "good quality of life” were negatively associated with CRNs’ stress scores; and (4) "sleep quality in the last two weeks", "retention rate in the next year", "clinical nurses' seniority" and "the stress levels of CRN" were important factors associated with the quality of life among CRNs.
Conclusion
The results show that the Chinese version of SSCRC was a valid and reliable scale that can be allied in Taiwan. The mental health of CRNs was significantly related to work-related stress and neuroticism, cancer-related clinical trials, salary and welfare satisfaction were all important factors associated with CRNs’ work stress. Therefore, the government should paid more attention on the workload of CRNs, specify their professional roles, and professional training of CRNs. The educational topics for the CRNs training can consider the topics relate to management of protocol deviations, and complex design of the clinical trials.It is of hope that the government, the trail agencies, and the employers of the CRNs can continuously improve the workload, make clear role definitions and job descriptions, as well as develop the professional competencies of the CRNs. All these efforts will enhance the quality of global clinical trials conducted in Taiwan and have an important impact on the safety of trail participants.

並列關鍵字

Clinical Trials ； Clinical Research Nurses ； Work Related Stress ； Mental health ； Neuroticism ； Quality of Life

參考文獻

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