The impact of the double blinded randomized control trial Brave Dreams on the nursing staff

• Main Authors: Clara Todini, Michela Zanandrea
• Format: Article
• Language: English
• Published: PAGEPress Publications 2018-10-01
• Series: Veins and Lymphatics
• Subjects: Brave Dreams trial; randomized control trials; chronic cerebrospinal venous insufficiency; multiple sclerosis; nursing.
• Online Access: https://www.pagepressjournals.org/index.php/vl/article/view/7662

The objective of this study is a qualitative pilot survey to evaluate the impact of the double-blinded randomized controlled surgical trial Brave Dreams on the nursery staff. Chronic cerebrospinal venous insufficiency (CCSVI) is a condition frequently associated to multiple sclerosis, and characterized by impaired venous drainage of the brain and spinal cord as a result of outflow obstruction in the extracranial venous system. The trial was of paramount importance, because the main objective was to test whether re-establishing a correct venous drainage could have therapeutic implications for multiple sclerosis patients, when the disease was associated to CCSVI. Basically, Brave Dreams assessed the efficacy and safety of percutaneous transluminal angioplasty of extracranial veins. To assess the impact of the trial on the nursery staff, an ad hoc questionnaire was used to test a sample of 8 nurses. The tests investigated 5 macro areas: i) managing of patient assistance; ii) how the research team trained the nursery staff; iii) unmasking efficacy; iv) the overall satisfaction of the nursery staff; v) possible introduction of subjects that explain the methodology of clinical trials during degree nursing education. Data analysis showed that assistance in a trial context must be personalized and based on primary nursing principles. It also showed that staff training was extremely satisfying and helpful to the study successful outcome. Furthermore, it showed that each patient was convinced to have undergone a percutaneous transluminal angioplasty, and not a sham procedure. Moreover, the survey showed a strong synergy between the patients and the nursery staff involved in the study. Our conclusions are to examine in depth the notions of professional deontology, ethical behavior and patients’ psychology whenever nurses are called to take part in clinical randomized trials.