Sampling procedure
pruritus, pain, urinary and bowel urgency, Cancer
CANCER
There were two treatment arms, Shea Lubricant (A) and 2% lidocaine gel (B). A clinical trial randomization software (National Cancer Institute Clinical Trial Randomization tool) was employed to allocate patients to the two groups using a 1:1 allocation ratio. Patients assigned odd numbers were randomized to Group A and those assigned an even number, to Group B. The process continued till the required number of participants was obtained in the two groups. The examination procedure was explained after informed consent was sought from each patient. Participants were assured of their privacy, confidentiality and their rights to opt out of the trial at any point in time without affecting access to quality care. Structured questionnaires were administered before, immediately and 30 min after the procedure to assess pain perception, peri-anal discomfort and pruritus, and urinary and bowel urgency. The questionnaire also evaluated trial doctors’ assessment of ‘ease of use’ of the lubricants.