Methods of randomization and data collection
’ perception of anal pain, pruritus, pain, ’
RECRUITMENT
The allocation sequence was concealed from trial doctors and nurses and only revealed to the trial nurse upon the recruitment of a participant while keeping the trial doctor in oblivion. The sequence was generated by an investigator assigned for that purpose whilst the trial nurses enrolled, assigned participants to an intervention and also assessed outcomes. Study participants were blinded to the interventions. However, since the consistency of the products was distinguishable the trial doctors could not be blinded. The study used a quantitative data collection approach. A structured questionnaire consisted of three sections (1) socio-demographic characteristics, (2) patients’ perception, (3) ease of use of the lubricants. Patients’ perception of anal pain was evaluated with a Visual Analogue scale which rated pain from the most excruciating (10) to no pain (0). Peri-anal discomfort, pruritus, bowel and urinary urgency were assessed using 4-dimension Likert scales to each of the questions. Similarly, a 5-dimension Likert scale determined the ease of use of lubricants by clinicians. Questionnaires were administered through face-to-face interviews after written informed consent had been obtained with the privacy, confidentiality and security of patients’ data assured. Quality control measures instituted prior to data collection include (1) training of research assistants, trial doctors and nurses on data collection and informed consent. (2) Error correction. (3) Appropriate storage of investigational products. The data collected was entered daily and validated. The authors vouch for the accuracy of data and the fidelity of the study to the protocol.