探討臨床研究護理師倫理道德困擾、工作壓力與職業倦怠

研究背景：倫理道德困擾在護理專業中指當護理師知道何為正確的事情且該去執行，但由於受到限制，無法採取適切行動時所產生的痛苦感。臨床試驗是發展新治療或新藥物必經之路，對於第一線接觸受試者的臨床研究護理師（clinical research nurse, CRN），可能面臨角色衝突或產生倫理困境，對執行試驗研究計畫和提供受試者照護，可能因為雙重角色義務而面臨獨特的倫理道德挑戰。研究目的：本研究主旨為探討臺灣臨床研究護理師於執行臨床試驗時感受的倫理道德困擾（moral distress）、工作壓力與職業倦怠現況及相關性。研究方法：本研究採用橫斷式設計，以立意取樣於臺灣執行臨床試驗之各醫療院所邀請具執行臨床試驗計畫6個月以上之臨床研究護理師參加，採問卷調查法以中文版倫理道德困擾問卷、中文版臨床研究護理師工作壓力源量表、職業倦怠（burnout）評估、憂鬱自我評估量表收集資料。研究結果：研究共納入197位研究護理師，發現臨床研究護理師職業倦怠高之相關因素包含：工作負荷高度、倫理道德困擾程度高、工作壓力大、憂鬱程度高、護理師工作年資10年以上、執行血液科試驗案等；另一方面，倫理道德困擾頻率高及執行第三期臨床試驗之研究護理師，反而呈現較少的職業倦怠，此多元羅吉斯迴歸模型整體解釋力為63.7%。另外也發現倫理道德困擾與工作壓力間確實存在顯著正相關，本研究發現倫理道德困擾之所以對職業倦怠產生效果，是透過工作壓力之故，因此，工作壓力高可能是倫理道德困擾和職業倦怠的中介變項，整體模型解釋力達曲線下面積（AUC）為0.912。結論：本研究結果顯示臨床研究護理師職業倦怠與倫理道德困擾、工作壓力、工作負荷、憂鬱等有相關性，且倫理道德困擾是透過工作壓力之中介，進而影響職業倦怠，職業倦怠與人力流失、臨床試驗執行品質、與試驗受試者互動等均息息相關，改善研究護理師之工作壓力與道德倫理困境，將是降低職業倦怠與提升臨床試驗品質的關鍵，應更加受到重視。

關鍵字

臨床研究護理師；道德困擾；倫理困境；工作壓力；工作負荷；職業倦怠

並列摘要

Background：Moral distress in the nursing profession refers to the suffering that arises when a nurse knows what is right and should be done, but is constrained from taking appropriate action. Clinical trials are the way to develop new treatments or new drugs. For the clinical research nurses (CRNs) who are in contact with study participants in the front line, they may face role conflicts or generate ethical dilemmas. Conducting clinical trial research and providing participant care may present unique ethical challenges due to dual role obligations for CRNs. Purpose：The purpose of this study was to investigate the current situation and correlation of ethical and moral distress, work stress and job-related burnout among clinical research nurses in Taiwan while conducting clinical trials. Methods：This study adopted a cross sectional study design, and invited CRNs with at least 6-months clinical trial experience to participant. Several instruments are used, including the Chinese version of Measure of Moral Distress – Healthcare Professionals (MMD-HP), The Chinese version of the Stressor Scale for Clinical Research Coordinator (SSCRC), a single-item measurement and assessment of burnout, and The Patient Health Questionnaire – 2 (PHQ-2). Results：A total of 197 CRNs were included in the study, and it was found that the factors related to the high burnout of CRNs included: high workload, high degree of ethical and moral distress, high work pressure, high degree of depression, nurses with more than 10 years of work experience, and execution of hematology trials. On the other hand, CRNs with a high frequency of ethical and moral distress and performing Phase III clinical trials showed less burnout, and the overall explanatory power of this multivariable logistic regression model was 63.7%. It was also found that there was indeed a significant positive correlation between ethical and moral distress and work stress. This study found that ethical and moral distress has an effect on burnout through work stress, so high work stress may be a mediating factor between ethical and moral distress and burnout. The overall model explains the area under the curve (AUC) of 0.912. Conclusions：The results of this study show that burnout of CRNs is associated with ethical and moral distress, work stress, workload, depression, etc. Moreover, ethical and moral distress are mediated by work stress, which in turn affects burnout, which is closely related to manpower loss, the quality of clinical trial execution, and interaction with trial participants. Improving the work stress and ethical and moral distress of CRNs will be the key to reducing burnout and improving the quality of clinical trials, and should be given more attention in the future.

並列關鍵字

Clinical Research Nurses ； CRN ； Moral Distress ； Ethical Dilemma ； Work Stress ； Workload ； Burnout

參考文獻

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探討臨床研究護理師倫理道德困擾、工作壓力與職業倦怠

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