5. Randomization Procedure
PIS
Patients were randomized into two arms, i.e., control and intervention arms, using single block randomization. Block randomization with unequal block sizes of 4 and 6 is used to minimize selection bias, and 1 : 1 allocation will be done for intervention and control groups. For each block in the sequence, the permutation was selected using simple random sampling, and the same was followed for each of the 31 blocks, as shown in the example, and allocation concealment was done. Participants had an equal probability of being assigned to any given group. Finally, 160 patients participated in the study. Each group consisted of 80 patients.Ethical clearance (441/2015) was obtained from the Institutional Ethics Committee of Kasturba Hospital, MAHE, Manipal, and registered under the Clinical Trial Registry of India's CTRI Registration Number: Trial REF/2017/12/016258. As per the ethical guidelines, a participant information sheet (PIS) and informed consent (IC) for participants were administered.