The brisk air has remained within the tenure of the atmosphere. Maples are still bare, ever limber from the insidiously declining temperatures. Snow now paints the backdrop of the window pane. Winter, is in fact upon us. Through this paned glass, nurses look out at the vast horizon. How could they possibility conduct research within the realm of pediatric anxiety that meets ethical standards? Hey everyone, and welcome to the third installment of the Morning Read with Zach Gaudette.
Ethical principles for standing within current research denote the importance of safe guarding ethical standards for the protection of its participants (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, & Social Sciences and Humanities Research Council of Canada, p. 5). The Tri-Council Policy Statement (TCPS) on Ethical Conduct for Research Involving Humans provides a guiding framework for the application of ethical policy in research practice (Canadian Institutes of Health Research et al., 2014, p. 11). With successful application, research under construct is fortified in a legal and ethical manner (Canadian Institutes of Health Research et al., 2014, p. 13; Shaddy & Denne, 2010). Alternatively, ethics approval of the study should also be sought after when conducting research to further demonstrate ethical principles in conjunction with the potential to displaying clinical relevance (Agha, Borrelli, Vella-Baldacchino, Thavayogan, & Orgill, 2017).
As eluded to in the Morning Read: Volume II, the purpose of this research proposal will be to measure the effectiveness of therapeutic play on pediatric patients with varying developmental stages between the ages of two to six admitted for preoperative surgical procedures in two Ontario pediatric hospitals. The Randomized Control Trial (RCT) will employ the use of a positivist paradigm for the research proposal. This aligns the methodology to the appropriate paradigm, as the research question(s) pose to answer a single reality that can be measured with quantitative means (LoBiondo-Wood, Haber, Cameron, & Singh, 2018).
There are three core ethical considerations accompanied in the TCPS Ethical Conduct for Research Involving Humans document (Canadian Institutes of Health Research et al., 2014, p. 6). Accordingly, the considerations are stated as respect for persons, concern for welfare and justice (Canadian Institutes of Health Research et al., 2014, p. 6). All considerations will be present within the study and outlined below.
The samples inclusion criteria is based upon patients being between the ages of two to six years old, and needing to be undergoing elective surgery with parental consent obtained. Exclusion criteria is implemented for patients who have undergone numerous surgeries, if no consent could be obtained and if the patient has a diagnosed condition that is known to cause developmental delay. The research proposal plans to utilize the modified-Yale Preoperative Assessment Scale (m-YPAS), the Nipissing District Developmental Screen (NDDS), the State Trait Anxiety Inventory for Children (STAI-C) and vital signs as data collection methods. Exclusion criterion was placed based upon previous studies, literature, and in addition to maintaining ethical principles. Firstly, the need to exclude patients based upon the previous number of surgical interventions is emphasized due to the realization that previous literature states the recognition of pediatric development and milestones becoming impeded if several hospitalized visits are perceived as anxiety-provoking experiences (Al-Yateem, & Rossiter, 2016). Further, if no parental consent was obtained, then the need for exclusion is based upon standards set forth by the Canadian Institutes of Health Research et al. (2014), where consent in needed for participants to become a part of the study at hand (p. 46). This promotes the TCPS position on ethically considering respect for persons, as due to the pediatric nature of the research proposal, entrusted third-party parental consent of the patient will have to be obtained for inclusion within the study (Canadian Institutes of Health Research et al., 2014, p. 7).
Patient information will be safeguarded ensuring succinct confidentiality. Provided that, concerns for welfare is addressed in the research proposal. The TCPS expresses privacy, formal control of the patient’s information and informed consent as factors contributing to welfare within a study (Canadian Institutes of Health Research et al., 2014, p. 7). This will be achieved with patients being assigned a numerical character when obtaining, recording, and examining data throughout the entirety of the study. Continuing, only researchers conducting the research will have access to patient information with files being password protected. Informed consent will be obtained from the legal guardian(s) with the participant present, ensuring both parties understand the purpose and premise of the study.
Subsequently, ensuring justice within the research proposal also delineates importance to protecting pediatric participants. The relevance is highlighted within the Ethical Conduct for Research Involving Humans document, as the Canadian Institutes of Health Research et al. (2014) state pediatric patients as a vulnerable population due to the lack of autonomy they possess due to the inability to make informed decisions without guardian consent (p. 8). For the promotion of justice, participants should feel supported throughout the research study (Canadian Institutes of Health Research et al., 2014, p. 8). Perry et al. (2013) voice support for pediatric patients within hospitalized settings is best fostered with the child being able to see their parent whenever possible. Therefore, the study will ensure all participants will have easy accessibility to their parent or guardian when needed.
Thank you for continuing the journey with me, this has been an ethical installment of the Morning Read with Zach Gaudette.
Agha, R.A., Borrelli, M.R., Vella-Baldacchino, M., Thavayogan, R., & Orgill, D.P. (2017). The STROCSS statement: Strengthening the reporting of cohort studied in surgery. International Journal of Surgery, 46(1), 198-202. doi: https://doi.org/10.1016/j.ijsu.2017.08.586
Al-Yateem, N., & Rossiter R.C. (2017). Unstructured play for anxiety in pediatric inpatient care. Journal for Specialists in Pediatric Nursing, 22(1), 1-7. doi: 10.111/jspn.12166
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. (December 2014). Tri-Council policy statement: Ethical conduct for research involving humans. Retrieved from http://www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf
LoBiondo-Wood, G., Haber, J., Cameron, C., & Singh, M. D. (2018). Nursing research in Canada: Methods, critical appraisal, and utilization. Toronto, ON, Canada: Elsevier Canada.
Perry, S., Hockenberry, M., Lowdermilk, D.L., Wilson, D., Keenan-Lindsay, L., & Sams, C.A. (2013). Maternal child nursing care in Canada. Toronto: Elsevier.
Shaddy, R.E., & Denne, S.C. (2010). Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics, 125(2), 850-860. doi: 10.1542/peds.2010-0082