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| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 張榮珍(Jung-Chen Chang) | |
| dc.contributor.author | Yuan-Chih Cheng | en |
| dc.contributor.author | 鄭媛之 | zh_TW |
| dc.date.accessioned | 2022-11-25T06:34:40Z | - |
| dc.date.copyright | 2021-11-09 | |
| dc.date.issued | 2021 | |
| dc.date.submitted | 2021-10-15 | |
| dc.identifier.citation | Bagiella, E., Bhatt, D. L., Gaudino, M. (2020, Jul 21). The Consequences of the COVID-19 Pandemic on Non-COVID-19 Clinical Trials. J Am Coll Cardiol, 76(3), 342-345. https://doi.org/10.1016/j.jacc.2020.05.041 Boughey, J. C., Snyder, R. A., Kantor, O., Zheng, L., Chawla, A., Nguyen, T. T., Hillman, S. L., Hahn, O. M., Mandrekar, S. J., Roland, C. L. (2021, Jul 8). Impact of the COVID-19 Pandemic on Cancer Clinical Trials. Ann Surg Oncol, 1-6. https://doi.org/10.1245/s10434-021-10406-2 Catania, G., Poirè, I., Bernardi, M., Bono, L., Cardinale, F., Dozin, B. (2012, Feb). The role of the clinical trial nurse in Italy. Eur J Oncol Nurs, 16(1), 87-93. https://doi.org/10.1016/j.ejon.2011.04.001 Chen, C. S., Wu, H. Y., Yang, P., Yen, C. F. (2005, Jan). Psychological distress of nurses in Taiwan who worked during the outbreak of SARS. Psychiatr Serv, 56(1), 76-79. https://doi.org/10.1176/appi.ps.56.1.76 Dziuban, C. D., Shirkey, E. C. (1974). 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| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/82267 | - |
| dc.description.abstract | "背景與目的：COVID-19疫情可能對臨床試驗執行產生重大影響，疫情也會造成臨床研究護理師(clinical research nurse, CRN)工作改變，本研究目的在了解CRNs執行臨床試驗，如何受到COVID-19疫情影響，以及CRNs在疫情期間的工作壓力感受與身心健康。 方法： 採橫斷式研究設計，以文獻回顧收集各國在COVID-19疫情期間受到影響之臨床試驗事務，發展疫情對CRNs執行臨床試驗之影響量表，並同時收集基本資料、壓力感受、心理健康指標與個人防疫行為等資料，透過網路問卷收集資料，採取不記名單次填答，資料以SPSS軟體進行描述性及推論性統計分析。 結果與討論：共收案150位CRNs，多為女性及於北部工作。在台灣臨床試驗於疫情期間受到的衝擊包含收案減少、受試者回診頻率降低、CRNs遠距工作與廠商遠距稽核等因應。疫情下CRNs工作壓力有顯著正相關因素包含: 預計離開目前工作、自述憂鬱分數高及「試驗執行受疫情影響而改變」(例如:由CRNs或藥師寄送藥物給病人、開案會議改線上會議、稽核以遠距進行、花更多時間與病人、醫院或廠商溝通協調、需要回覆更多詢問等)；而與CRNs工作壓力呈顯著負相關的因素則有受僱身份是由臨床試驗機構管理組織(Site Management Organization, SMO)所聘任、具碩士學歷、以及「試驗執行受疫情影響而改變」(例如:受試者延長回診或延長領藥時間、疫情下採遠距工作模式、疫情下運動量減少等)，以上之多變量迴歸最終模型之整體解釋量為59.5%。此外，COVID-19疫情對臨床試驗活動的主要影響如下：受試者招募較困難、受試者的追蹤評估被迫取消或減少頻率、CRNs須遠距工作及贊助商或衛生主管機關需要遠距稽核等。 結論與建議：許多臨床試驗項目在疫情期間受到影響，疫情爆發初期，試驗計畫書當中尚未列出疫情期間的應對方法，導致試驗委託者、主持人與CRNs等工作上面臨挑戰與實務執行上的困難，因而可能增加工作壓力，建議未來可以在計畫書中列出發生重大公衛事件時的處理方法，例如藥物寄送、遠距看診、檢驗頻率調整與稽核方法改變等調整做法，讓試驗團隊，尤其是第一線的CRNs，即使在疫情期間，也能夠以最有效率的方式應對，避免計畫書程序違反或受試者權益受損。" | zh_TW |
| dc.description.provenance | Made available in DSpace on 2022-11-25T06:34:40Z (GMT). No. of bitstreams: 1 U0001-1410202118564800.pdf: 2989544 bytes, checksum: 2a3e862174e973dc12a1432f223ce9bc (MD5) Previous issue date: 2021 | en |
| dc.description.tableofcontents | "論文口試委員審定書 i 致謝 ii 中文摘要 iii Abstract v 表目錄 xi 圖目錄 xii 第一章 緒論 1 第一節 研究動機與重要性 1 第二節 研究目的 2 第三節 研究問題 2 一、 COVID-19疫情下，研究護理師的工作壓力之探討。 2 二、 探討臨床試驗執行之不同面向，受COVID-19影響的項目與影響程度。 2 三、 分析CRNs工作壓力與背景資料、焦慮憂鬱、疫情影響、防疫行為間之關聯性。 2 第二章 文獻查證 3 第一節 臨床研究護理師 3 第二節 SARS對醫護人員造成的影響 3 第三節 COVID-19對醫護人員造成的影響 4 第四節 COVID-19的影響 4 一、 癌症治療 4 二、 臨床試驗 5 三、 疫情影響臨床研究護理師之工作 9 四、 護理師之工作壓力 10 第三章 研究方法 11 第一節 研究設計 11 第二節 研究對象與場所 11 一、 研究場所 11 二、 納入條件與排除條件 11 三、 樣本數估計 12 第三節 研究假設 13 一、 CRN之工作壓力與臨床試驗受影響項目呈現正相關 13 二、 CRN的背景會影響疫情期間的CRN工作壓力 13 第四節 研究工具 13 一、 基本資料 13 二、 病人健康量表(The Patient Health Questionnaire-2, PHQ-2) 13 三、 臨床研究護理師壓力源量表 13 四、 受到疫情影響之臨床試驗事務 14 五、 個人和COVID-19相關之改變 15 第五節 資料收集過程 16 第六節 資料統計與分析 16 一、 描述性統計 16 二、 推論性統計 16 第七節 倫理考量 17 第四章 研究結果 18 第一節 研究對象基本資料 18 第二節 專家效度檢定 21 第三節 SSCRC量表分析 26 第四節 臨床研究護理師身心健康情形 35 第五節 受疫情影響之臨床試驗項目量表之分析 38 一、 內在一致性分析 38 二、 臨床試驗項目受疫情影響之程度 39 第六節 個人防疫行為與感受量表相關分析 42 一、 內在一致性分析 42 二、 個人防疫行為與感受分析 43 第七節 受疫情影響之臨床試驗項目與CRNs工作壓力之相關性 44 第八節 CRN背景、身心健康、臨床試驗事務、防疫行為與工作壓力之相關性 47 一、 類別變項之編碼轉換 47 二、 SSCRC量表總分與各變項間的多元迴歸分析 49 第五章 討論 53 第一節 台灣於疫情期間受影響之臨床試驗項目 53 一、 工作模式 53 二、 試驗進度 54 三、 同意書 54 四、 監督與稽核 54 五、 不良反應與計畫書偏差Protocol deviation 54 第二節 疫情期間CRN工作壓力與相關之因素 55 一、 疫情間的工作壓力變化 55 二、 臨床試驗項目 55 三、 個人防疫行為與感受 56 四、 影響CRNs工作壓力之因素探討 56 第三節 CRNs疫苗接種態度 59 第四節 SSCRC因素分析 59 第六章 結論與建議 61 第一節 結論 61 第二節 限制 61 第三節 建議與未來應用 61 一、 臨床試驗Protocol中需列出發生重大公衛事件之應變方式 61 二、 CRN工作相關之建議 62 三、 臨床試驗執行之未來方向 62 第七章 參考資料 64 附錄 70 附錄一、專家效度問卷 70 附錄二、專家名單 75 附錄三、線性迴歸stepwise原始表格 75 附錄四、研究問卷 80" | |
| dc.language.iso | zh-TW | |
| dc.subject | 臨床研究護理師 | zh_TW |
| dc.subject | 工作壓力 | zh_TW |
| dc.subject | 臨床試驗 | zh_TW |
| dc.subject | 身心健康 | zh_TW |
| dc.subject | COVID-19 | zh_TW |
| dc.subject | 嚴重特殊傳染性肺炎 | zh_TW |
| dc.subject | Coronavirus pneumonia | en |
| dc.subject | COVID-19 | en |
| dc.subject | work-related stress | en |
| dc.subject | Clinical trial | en |
| dc.subject | Clinical research nurse | en |
| dc.subject | Mental health | en |
| dc.title | COVID-19疫情對臨床研究護理師工作內容及壓力感受之影響 | zh_TW |
| dc.title | The Impact of COVID-19 Pandemic on Clinical Research Nurses’ Practice and Work-Related Stress | en |
| dc.date.schoolyear | 109-2 | |
| dc.description.degree | 碩士 | |
| dc.contributor.oralexamcommittee | 陳建煒(Hsin-Tsai Liu),陳淑惠(Chih-Yang Tseng) | |
| dc.subject.keyword | 臨床研究護理師,臨床試驗,工作壓力,身心健康,COVID-19,嚴重特殊傳染性肺炎, | zh_TW |
| dc.subject.keyword | Clinical research nurse,Clinical trial,work-related stress,COVID-19,Coronavirus pneumonia,Mental health, | en |
| dc.relation.page | 86 | |
| dc.identifier.doi | 10.6342/NTU202103731 | |
| dc.rights.note | 未授權 | |
| dc.date.accepted | 2021-10-15 | |
| dc.contributor.author-college | 醫學院 | zh_TW |
| dc.contributor.author-dept | 護理學研究所 | zh_TW |
| dc.date.embargo-lift | 2026-10-01 | - |
| 顯示於系所單位： | 護理學系所 | |
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| U0001-1410202118564800.pdf 未授權公開取用 | 2.92 MB | Adobe PDF | 檢視/開啟 |
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