Management of participants
Given the external nature of the treatment employed in this study, achieving absolute blinding of participants was challenging. First, both treatment investigators and research nurses should be strictly instructed not to reveal specific treatment protocol details to patients. Secondly, to minimize the potential for inter-patient communication, it is advisable to avoid accommodating patients from different treatment groups in the same room. Lastly, patients must receive thorough education and it must be emphasized that they should not share their treatment information with anyone except their treating physician and research nurse. The participants’ understanding of these crucial blinding maintenance requirements will be assessed during the participant screening process. Any participant unable to comprehend these requirements will not be included in the study.